Trial Outcomes & Findings for Acupuncture for Chronic Low Back Pain in Older Adults (NCT NCT04982315)

Last Updated: 2026-01-06

Results Overview

Change in back-related disability is defined as score change in Roland Morris Disability Questionnaire (RMDQ), a 24-item questionnaire which asked whether 24 specific activities were limited due to back pain during the past week. The RMDQ is scored from 0 to 24, with higher scores indicating more disability. Greater change between baseline and 6-months would indicate greater improvement.

Recruitment status

COMPLETED

Study phase

Target enrollment

807 participants

Primary outcome timeframe

Baseline to 6-month

Results posted on

2026-01-06

Participant Flow

Participants with chronic low back pain that had persisted for \>3 months were recruited from four different health systems. The first participant was enrolled in August 2021 and the last participant was enrolled October 2022.

Of 12,438 participants screened for eligibility, 800 were randomized and enrolled in the study.

Participant milestones

Participant milestones
Measure	Usual Care Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study.	Standard Acupuncture Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Enhanced Acupuncture Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.
Overall Study STARTED	266	265	269
Overall Study 3-Month Survey	218	247	252
Overall Study 6-Month Survey	223	247	248
Overall Study 12-Month Survey	220	244	239
Overall Study COMPLETED	237	260	256
Overall Study NOT COMPLETED	29	5	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study.	Standard Acupuncture Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Enhanced Acupuncture Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.
Overall Study Death	1	0	1
Overall Study Lack of Efficacy	0	0	2
Overall Study Withdrawal by Subject	24	1	2
Overall Study Dealing with health/life issues	3	4	7
Overall Study Privacy concerns	1	0	0
Overall Study Withdrawal by research team	0	0	1

Baseline Characteristics

Missing data for 2 participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=266 Participants Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study.	Standard Acupuncture n=265 Participants Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Enhanced Acupuncture n=269 Participants Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Total n=800 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=266 Participants	0 Participants n=265 Participants	0 Participants n=269 Participants	0 Participants n=800 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=266 Participants	0 Participants n=265 Participants	0 Participants n=269 Participants	0 Participants n=800 Participants
Age, Categorical >=65 years	266 Participants n=266 Participants	265 Participants n=265 Participants	269 Participants n=269 Participants	800 Participants n=800 Participants
Age, Continuous	73.7 Years STANDARD_DEVIATION 6.0 • n=266 Participants	73.4 Years STANDARD_DEVIATION 5.8 • n=265 Participants	73.8 Years STANDARD_DEVIATION 6.1 • n=269 Participants	73.6 Years STANDARD_DEVIATION 6.0 • n=800 Participants
Age, Customized 65-74 years old	157 Participants n=266 Participants	159 Participants n=265 Participants	156 Participants n=269 Participants	472 Participants n=800 Participants
Age, Customized 75-84 years old	94 Participants n=266 Participants	95 Participants n=265 Participants	98 Participants n=269 Participants	287 Participants n=800 Participants
Age, Customized 85+ years old	15 Participants n=266 Participants	11 Participants n=265 Participants	15 Participants n=269 Participants	41 Participants n=800 Participants
Sex: Female, Male Female	167 Participants n=266 Participants	164 Participants n=265 Participants	164 Participants n=269 Participants	495 Participants n=800 Participants
Sex: Female, Male Male	99 Participants n=266 Participants	101 Participants n=265 Participants	105 Participants n=269 Participants	305 Participants n=800 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=266 Participants	33 Participants n=265 Participants	28 Participants n=269 Participants	85 Participants n=800 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	230 Participants n=266 Participants	217 Participants n=265 Participants	227 Participants n=269 Participants	674 Participants n=800 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=266 Participants	15 Participants n=265 Participants	14 Participants n=269 Participants	41 Participants n=800 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=266 Participants	2 Participants n=265 Participants	1 Participants n=269 Participants	6 Participants n=800 Participants
Race (NIH/OMB) Asian	14 Participants n=266 Participants	16 Participants n=265 Participants	13 Participants n=269 Participants	43 Participants n=800 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=266 Participants	0 Participants n=265 Participants	0 Participants n=269 Participants	3 Participants n=800 Participants
Race (NIH/OMB) Black or African American	41 Participants n=266 Participants	55 Participants n=265 Participants	43 Participants n=269 Participants	139 Participants n=800 Participants
Race (NIH/OMB) White	187 Participants n=266 Participants	159 Participants n=265 Participants	186 Participants n=269 Participants	532 Participants n=800 Participants
Race (NIH/OMB) More than one race	4 Participants n=266 Participants	9 Participants n=265 Participants	5 Participants n=269 Participants	18 Participants n=800 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=266 Participants	24 Participants n=265 Participants	21 Participants n=269 Participants	59 Participants n=800 Participants
Education HS Diploma or less	33 Participants n=266 Participants • Missing data for 2 participants	36 Participants n=264 Participants • Missing data for 2 participants	38 Participants n=268 Participants • Missing data for 2 participants	107 Participants n=798 Participants • Missing data for 2 participants
Education At least some college	147 Participants n=266 Participants • Missing data for 2 participants	154 Participants n=264 Participants • Missing data for 2 participants	141 Participants n=268 Participants • Missing data for 2 participants	442 Participants n=798 Participants • Missing data for 2 participants
Education College graduate or higher degree	86 Participants n=266 Participants • Missing data for 2 participants	74 Participants n=264 Participants • Missing data for 2 participants	89 Participants n=268 Participants • Missing data for 2 participants	249 Participants n=798 Participants • Missing data for 2 participants
Clinical Site IFH	39 Participants n=266 Participants	42 Participants n=265 Participants	42 Participants n=269 Participants	123 Participants n=800 Participants
Clinical Site KPNC	96 Participants n=266 Participants	93 Participants n=265 Participants	97 Participants n=269 Participants	286 Participants n=800 Participants
Clinical Site KPWA	62 Participants n=266 Participants	62 Participants n=265 Participants	61 Participants n=269 Participants	185 Participants n=800 Participants
Clinical Site Sutter	69 Participants n=266 Participants	68 Participants n=265 Participants	69 Participants n=269 Participants	206 Participants n=800 Participants
Household Income Less than $25,000	30 Participants n=261 Participants • Missing data for 38 participants.	37 Participants n=260 Participants • Missing data for 38 participants.	32 Participants n=241 Participants • Missing data for 38 participants.	99 Participants n=762 Participants • Missing data for 38 participants.
Household Income $25,000 - $49,999	47 Participants n=261 Participants • Missing data for 38 participants.	42 Participants n=260 Participants • Missing data for 38 participants.	35 Participants n=241 Participants • Missing data for 38 participants.	124 Participants n=762 Participants • Missing data for 38 participants.
Household Income $50,000 - $99,999	77 Participants n=261 Participants • Missing data for 38 participants.	79 Participants n=260 Participants • Missing data for 38 participants.	67 Participants n=241 Participants • Missing data for 38 participants.	223 Participants n=762 Participants • Missing data for 38 participants.
Household Income $100,000 - $149,999	64 Participants n=261 Participants • Missing data for 38 participants.	72 Participants n=260 Participants • Missing data for 38 participants.	76 Participants n=241 Participants • Missing data for 38 participants.	212 Participants n=762 Participants • Missing data for 38 participants.
Household Income $150,000 or more	43 Participants n=261 Participants • Missing data for 38 participants.	30 Participants n=260 Participants • Missing data for 38 participants.	31 Participants n=241 Participants • Missing data for 38 participants.	104 Participants n=762 Participants • Missing data for 38 participants.
Received Disability for Lower Back Pain	29 Participants n=266 Participants	24 Participants n=265 Participants	24 Participants n=269 Participants	77 Participants n=800 Participants
Married or Domestic Partnered	156 Participants n=266 Participants	147 Participants n=265 Participants	152 Participants n=269 Participants	455 Participants n=800 Participants
Pain Limits Work Never	13 Participants n=265 Participants • Missing data for 2 participants	12 Participants n=265 Participants • Missing data for 2 participants	8 Participants n=268 Participants • Missing data for 2 participants	33 Participants n=798 Participants • Missing data for 2 participants
Pain Limits Work Some Days	134 Participants n=265 Participants • Missing data for 2 participants	122 Participants n=265 Participants • Missing data for 2 participants	120 Participants n=268 Participants • Missing data for 2 participants	376 Participants n=798 Participants • Missing data for 2 participants
Pain Limits Work Most Days	71 Participants n=265 Participants • Missing data for 2 participants	79 Participants n=265 Participants • Missing data for 2 participants	78 Participants n=268 Participants • Missing data for 2 participants	228 Participants n=798 Participants • Missing data for 2 participants
Pain Limits Work Every Day	47 Participants n=265 Participants • Missing data for 2 participants	52 Participants n=265 Participants • Missing data for 2 participants	62 Participants n=268 Participants • Missing data for 2 participants	161 Participants n=798 Participants • Missing data for 2 participants
BMI Underweight (<18.5 kg.m2)	3 Participants n=261 Participants • Missing data for 12 participants	4 Participants n=263 Participants • Missing data for 12 participants	4 Participants n=264 Participants • Missing data for 12 participants	11 Participants n=788 Participants • Missing data for 12 participants
BMI Normal (18.5 - <25 kg/m2)	73 Participants n=261 Participants • Missing data for 12 participants	80 Participants n=263 Participants • Missing data for 12 participants	85 Participants n=264 Participants • Missing data for 12 participants	238 Participants n=788 Participants • Missing data for 12 participants
BMI Overweight (25 - <30 kg/m2)	99 Participants n=261 Participants • Missing data for 12 participants	94 Participants n=263 Participants • Missing data for 12 participants	93 Participants n=264 Participants • Missing data for 12 participants	286 Participants n=788 Participants • Missing data for 12 participants
BMI Obese (>=30 kg/m2)	86 Participants n=261 Participants • Missing data for 12 participants	85 Participants n=263 Participants • Missing data for 12 participants	82 Participants n=264 Participants • Missing data for 12 participants	253 Participants n=788 Participants • Missing data for 12 participants
BMI Mean	28.4 kg/m^2 STANDARD_DEVIATION 6.4 • n=261 Participants • Missing BMI data for 12 participants	28.1 kg/m^2 STANDARD_DEVIATION 6.0 • n=263 Participants • Missing BMI data for 12 participants	28.0 kg/m^2 STANDARD_DEVIATION 5.9 • n=264 Participants • Missing BMI data for 12 participants	28.1 kg/m^2 STANDARD_DEVIATION 6.1 • n=788 Participants • Missing BMI data for 12 participants
Frailty Robust Health	82 Participants n=257 Participants • Missing complete data for 33 participants	63 Participants n=255 Participants • Missing complete data for 33 participants	78 Participants n=255 Participants • Missing complete data for 33 participants	223 Participants n=767 Participants • Missing complete data for 33 participants
Frailty Pre-Frailty	126 Participants n=257 Participants • Missing complete data for 33 participants	134 Participants n=255 Participants • Missing complete data for 33 participants	128 Participants n=255 Participants • Missing complete data for 33 participants	388 Participants n=767 Participants • Missing complete data for 33 participants
Any Opioid in Prior 3 Months	44 Participants n=266 Participants	35 Participants n=265 Participants	31 Participants n=269 Participants	110 Participants n=800 Participants
Long-term Opioid Therapy	14 Participants n=266 Participants	7 Participants n=265 Participants	3 Participants n=269 Participants	24 Participants n=800 Participants
Frailty Frailty	49 Participants n=257 Participants • Missing complete data for 33 participants	58 Participants n=255 Participants • Missing complete data for 33 participants	49 Participants n=255 Participants • Missing complete data for 33 participants	156 Participants n=767 Participants • Missing complete data for 33 participants
Frailty Mean	1.3 units on a scale STANDARD_DEVIATION 1.2 • n=257 Participants • Missing data for 33 participants.	1.5 units on a scale STANDARD_DEVIATION 1.2 • n=255 Participants • Missing data for 33 participants.	1.3 units on a scale STANDARD_DEVIATION 1.2 • n=255 Participants • Missing data for 33 participants.	1.4 units on a scale STANDARD_DEVIATION 1.2 • n=767 Participants • Missing data for 33 participants.
Medical Morbidity (Elixhauser)	2.4 units on a scale STANDARD_DEVIATION 1.9 • n=265 Participants • Missing data for 2 participants	2.6 units on a scale STANDARD_DEVIATION 2.1 • n=264 Participants • Missing data for 2 participants	2.5 units on a scale STANDARD_DEVIATION 2.1 • n=269 Participants • Missing data for 2 participants	2.5 units on a scale STANDARD_DEVIATION 2.0 • n=798 Participants • Missing data for 2 participants
Multiple Musculoskeletal Pain Conditions	224 Participants n=266 Participants	220 Participants n=265 Participants	243 Participants n=269 Participants	687 Participants n=800 Participants
Number of Musculoskeletal Pain Conditions	1.6 Number of conditions STANDARD_DEVIATION 1.1 • n=266 Participants	1.7 Number of conditions STANDARD_DEVIATION 1.2 • n=265 Participants	1.7 Number of conditions STANDARD_DEVIATION 1.0 • n=269 Participants	1.7 Number of conditions STANDARD_DEVIATION 1.1 • n=800 Participants
Types of Painful Conditions Back pain	229 Participants n=266 Participants	228 Participants n=265 Participants	250 Participants n=269 Participants	707 Participants n=800 Participants
Types of Painful Conditions Neck pain	59 Participants n=266 Participants	60 Participants n=265 Participants	43 Participants n=269 Participants	162 Participants n=800 Participants
Types of Painful Conditions Fibromyalgia	2 Participants n=266 Participants	6 Participants n=265 Participants	5 Participants n=269 Participants	13 Participants n=800 Participants
Types of Painful Conditions Limb/extremity, joint, and non-systemic, non-inflammatory arthritic pain	175 Participants n=266 Participants	176 Participants n=265 Participants	197 Participants n=269 Participants	548 Participants n=800 Participants
Types of Painful Conditions Musculoskeletal chest pain	36 Participants n=266 Participants	38 Participants n=265 Participants	34 Participants n=269 Participants	108 Participants n=800 Participants
Types of Painful Conditions Headache or migraine	26 Participants n=266 Participants	19 Participants n=265 Participants	22 Participants n=269 Participants	67 Participants n=800 Participants
Types of Painful Conditions Toothache, ear or jaw pain	3 Participants n=266 Participants	8 Participants n=265 Participants	6 Participants n=269 Participants	17 Participants n=800 Participants
Types of Painful Conditions General pain	127 Participants n=266 Participants	134 Participants n=265 Participants	147 Participants n=269 Participants	408 Participants n=800 Participants
Substance Use Disorder Diagnosis Substance use disorder	6 Participants n=266 Participants	8 Participants n=265 Participants	4 Participants n=269 Participants	18 Participants n=800 Participants
Substance Use Disorder Diagnosis Opioid use disorder	2 Participants n=266 Participants	1 Participants n=265 Participants	1 Participants n=269 Participants	4 Participants n=800 Participants
Substance Use Disorder Diagnosis Stimulant use disorder	0 Participants n=266 Participants	0 Participants n=265 Participants	1 Participants n=269 Participants	1 Participants n=800 Participants
Substance Use Disorder Diagnosis Sedative use disorder	0 Participants n=266 Participants	0 Participants n=265 Participants	2 Participants n=269 Participants	2 Participants n=800 Participants
Substance Use Disorder Diagnosis Alcohol use disorder	3 Participants n=266 Participants	8 Participants n=265 Participants	0 Participants n=269 Participants	11 Participants n=800 Participants
Substance Use Disorder Diagnosis Cannabis use disorder	2 Participants n=266 Participants	1 Participants n=265 Participants	0 Participants n=269 Participants	3 Participants n=800 Participants
Substance Use Disorder Diagnosis Other substance use disorder	0 Participants n=266 Participants	0 Participants n=265 Participants	0 Participants n=269 Participants	0 Participants n=800 Participants
Mental Health Mood Disorder Diagnosis Anxiety	46 Participants n=266 Participants	35 Participants n=265 Participants	46 Participants n=269 Participants	127 Participants n=800 Participants
Mental Health Mood Disorder Diagnosis Depression	40 Participants n=266 Participants	42 Participants n=265 Participants	37 Participants n=269 Participants	119 Participants n=800 Participants
General Anxiety Disorder Subscale of PHQ-4 (GAD 3+)	53 Participants n=266 Participants	63 Participants n=265 Participants	57 Participants n=269 Participants	173 Participants n=800 Participants
Personalized Health Questionnaire-2 (PHQ-2) (depression threshold of 3+)	51 Participants n=266 Participants	62 Participants n=265 Participants	49 Participants n=269 Participants	162 Participants n=800 Participants
Roland Morris Disability Questionnaire-Revised	12.86 units on a scale STANDARD_DEVIATION 5.5 • n=266 Participants	13.49 units on a scale STANDARD_DEVIATION 5.4 • n=265 Participants	13.19 units on a scale STANDARD_DEVIATION 5.5 • n=269 Participants	13.18 units on a scale STANDARD_DEVIATION 5.5 • n=800 Participants
Pain (PEG)	5.45 units on a scale STANDARD_DEVIATION 2.2 • n=266 Participants	6.06 units on a scale STANDARD_DEVIATION 1.9 • n=265 Participants	5.76 units on a scale STANDARD_DEVIATION 2.0 • n=269 Participants	5.85 units on a scale STANDARD_DEVIATION 2.0 • n=800 Participants
Tobacco, Alcohol, Prescription Medication, and Other Substance User (TAPS) Tool Tobacco Use	17 Participants n=266 Participants	19 Participants n=265 Participants	13 Participants n=269 Participants	49 Participants n=800 Participants
Pain Intensity	5.73 units on a scale STANDARD_DEVIATION 1.9 • n=266 Participants	6.06 units on a scale STANDARD_DEVIATION 1.9 • n=265 Participants	5.76 units on a scale STANDARD_DEVIATION 2.0 • n=269 Participants	5.85 units on a scale STANDARD_DEVIATION 2.0 • n=800 Participants
PROMIS Physical Function Subscale	38.31 units on a scale STANDARD_DEVIATION 6.4 • n=266 Participants	38.16 units on a scale STANDARD_DEVIATION 6.5 • n=265 Participants	38.14 units on a scale STANDARD_DEVIATION 6.8 • n=269 Participants	38.2 units on a scale STANDARD_DEVIATION 6.6 • n=800 Participants
PROMIS Sleep Disturbance Subscale	53.1 units on a scale STANDARD_DEVIATION 8.3 • n=266 Participants	54.63 units on a scale STANDARD_DEVIATION 8.6 • n=265 Participants	53.14 units on a scale STANDARD_DEVIATION 8.1 • n=269 Participants	53.62 units on a scale STANDARD_DEVIATION 8.3 • n=800 Participants
PROMIS Fatigue Subscale	55.19 units on a scale STANDARD_DEVIATION 8.7 • n=266 Participants	56.08 units on a scale STANDARD_DEVIATION 9.0 • n=265 Participants	54.75 units on a scale STANDARD_DEVIATION 9.0 • n=269 Participants	55.34 units on a scale STANDARD_DEVIATION 8.9 • n=800 Participants
Tobacco, Alcohol, Prescription Medication, and Other Substance User (TAPS) Tool Alcohol Use	40 Participants n=266 Participants	38 Participants n=265 Participants	36 Participants n=269 Participants	114 Participants n=800 Participants
PROMIS Engagement in Social Roles Subscale	45.72 units on a scale STANDARD_DEVIATION 8.2 • n=266 Participants	45.14 units on a scale STANDARD_DEVIATION 8.3 • n=265 Participants	45.55 units on a scale STANDARD_DEVIATION 8.5 • n=269 Participants	45.48 units on a scale STANDARD_DEVIATION 8.3 • n=800 Participants
Pain Catastrophizing	9.12 units on a scale STANDARD_DEVIATION 5.7 • n=266 Participants	10.77 units on a scale STANDARD_DEVIATION 5.9 • n=265 Participants	9.45 units on a scale STANDARD_DEVIATION 6.1 • n=269 Participants	9.78 units on a scale STANDARD_DEVIATION 5.9 • n=800 Participants
High Impact Chronic Pain	112 Participants n=266 Participants	125 Participants n=265 Participants	138 Participants n=269 Participants	375 Participants n=800 Participants
Sciatica	163 Participants n=266 Participants	186 Participants n=265 Participants	195 Participants n=269 Participants	544 Participants n=800 Participants
Expectations of Acupuncture	6.36 units on a scale STANDARD_DEVIATION 2.4 • n=266 Participants	6.37 units on a scale STANDARD_DEVIATION 2.4 • n=265 Participants	6.38 units on a scale STANDARD_DEVIATION 2.5 • n=269 Participants	6.37 units on a scale STANDARD_DEVIATION 2.4 • n=800 Participants
Sleep Duration	6.52 hours STANDARD_DEVIATION 1.3 • n=266 Participants	6.35 hours STANDARD_DEVIATION 1.5 • n=265 Participants	6.44 hours STANDARD_DEVIATION 1.4 • n=269 Participants	6.44 hours STANDARD_DEVIATION 1.4 • n=800 Participants
Fear Avoidance	49 Participants n=266 Participants	50 Participants n=265 Participants	51 Participants n=269 Participants	150 Participants n=800 Participants
Tobacco, Alcohol, Prescription Medication, and Other Substance User (TAPS) Tool TAPS Positive Screen (Any Use)	86 Participants n=266 Participants	73 Participants n=265 Participants	74 Participants n=269 Participants	233 Participants n=800 Participants
Tobacco, Alcohol, Prescription Medication, and Other Substance User (TAPS) Tool Illicit Drug Use	35 Participants n=266 Participants	30 Participants n=265 Participants	42 Participants n=269 Participants	107 Participants n=800 Participants
Tobacco, Alcohol, Prescription Medication, and Other Substance User (TAPS) Tool Prescription Drug Use	11 Participants n=266 Participants	6 Participants n=265 Participants	7 Participants n=269 Participants	24 Participants n=800 Participants
Self-Management Program Back Pain	23 Participants n=266 Participants	21 Participants n=265 Participants	30 Participants n=269 Participants	74 Participants n=800 Participants
Self-Management Program Other Needs	8 Participants n=266 Participants	4 Participants n=265 Participants	3 Participants n=269 Participants	15 Participants n=800 Participants
Self-Management Program None	234 Participants n=266 Participants	240 Participants n=265 Participants	235 Participants n=269 Participants	709 Participants n=800 Participants
Use of Mind-Body Techniques Back Pain	56 Participants n=264 Participants • Missing data for 9 participants.	60 Participants n=261 Participants • Missing data for 9 participants.	57 Participants n=266 Participants • Missing data for 9 participants.	173 Participants n=791 Participants • Missing data for 9 participants.
Use of Mind-Body Techniques Other Needs	29 Participants n=264 Participants • Missing data for 9 participants.	25 Participants n=261 Participants • Missing data for 9 participants.	31 Participants n=266 Participants • Missing data for 9 participants.	85 Participants n=791 Participants • Missing data for 9 participants.
Use of Mind-Body Techniques None	179 Participants n=264 Participants • Missing data for 9 participants.	176 Participants n=261 Participants • Missing data for 9 participants.	178 Participants n=266 Participants • Missing data for 9 participants.	533 Participants n=791 Participants • Missing data for 9 participants.
Use of Online Pain Management Program Back Pain	7 Participants n=266 Participants • Missing data for 7 participants.	8 Participants n=262 Participants • Missing data for 7 participants.	7 Participants n=265 Participants • Missing data for 7 participants.	22 Participants n=793 Participants • Missing data for 7 participants.
Use of Online Pain Management Program Other Needs	3 Participants n=266 Participants • Missing data for 7 participants.	0 Participants n=262 Participants • Missing data for 7 participants.	0 Participants n=265 Participants • Missing data for 7 participants.	3 Participants n=793 Participants • Missing data for 7 participants.
Use of Online Pain Management Program None	256 Participants n=266 Participants • Missing data for 7 participants.	254 Participants n=262 Participants • Missing data for 7 participants.	258 Participants n=265 Participants • Missing data for 7 participants.	768 Participants n=793 Participants • Missing data for 7 participants.
Psychological Counseling Back Pain	17 Participants n=266 Participants • Missing data for 4 participants	10 Participants n=265 Participants • Missing data for 4 participants	8 Participants n=265 Participants • Missing data for 4 participants	35 Participants n=796 Participants • Missing data for 4 participants
Psychological Counseling Other Needs	4 Participants n=266 Participants • Missing data for 4 participants	3 Participants n=265 Participants • Missing data for 4 participants	4 Participants n=265 Participants • Missing data for 4 participants	11 Participants n=796 Participants • Missing data for 4 participants
Psychological Counseling None	245 Participants n=266 Participants • Missing data for 4 participants	252 Participants n=265 Participants • Missing data for 4 participants	253 Participants n=265 Participants • Missing data for 4 participants	750 Participants n=796 Participants • Missing data for 4 participants
How has COVID affected your ability to get healthcare in the last 3 months? Reduced your ability to get healthcare a lot	22 Participants n=265 Participants • Missing data for 5 participants	31 Participants n=263 Participants • Missing data for 5 participants	17 Participants n=267 Participants • Missing data for 5 participants	70 Participants n=795 Participants • Missing data for 5 participants
How has COVID affected your ability to get healthcare in the last 3 months? Reduced your ability to get healthcare a little	59 Participants n=265 Participants • Missing data for 5 participants	47 Participants n=263 Participants • Missing data for 5 participants	61 Participants n=267 Participants • Missing data for 5 participants	167 Participants n=795 Participants • Missing data for 5 participants
How has COVID affected your ability to get healthcare in the last 3 months? Not affected your ability to get healthcare	180 Participants n=265 Participants • Missing data for 5 participants	181 Participants n=263 Participants • Missing data for 5 participants	182 Participants n=267 Participants • Missing data for 5 participants	543 Participants n=795 Participants • Missing data for 5 participants
How has COVID affected your ability to get healthcare in the last 3 months? Improved your ability to get healthcare	4 Participants n=265 Participants • Missing data for 5 participants	4 Participants n=263 Participants • Missing data for 5 participants	7 Participants n=267 Participants • Missing data for 5 participants	15 Participants n=795 Participants • Missing data for 5 participants
How has COVID affected your overall health in the last 3 months? Your overall health is a lot worse	17 Participants n=262 Participants • Missing data for 9 participants	21 Participants n=261 Participants • Missing data for 9 participants	19 Participants n=268 Participants • Missing data for 9 participants	57 Participants n=791 Participants • Missing data for 9 participants
How has COVID affected your overall health in the last 3 months? Your overall health is a little worse	81 Participants n=262 Participants • Missing data for 9 participants	85 Participants n=261 Participants • Missing data for 9 participants	72 Participants n=268 Participants • Missing data for 9 participants	238 Participants n=791 Participants • Missing data for 9 participants
How has COVID affected your overall health in the last 3 months? Not affected your overall health	159 Participants n=262 Participants • Missing data for 9 participants	152 Participants n=261 Participants • Missing data for 9 participants	172 Participants n=268 Participants • Missing data for 9 participants	483 Participants n=791 Participants • Missing data for 9 participants
How has COVID affected your overall health in the last 3 months? Improved your overall health	5 Participants n=262 Participants • Missing data for 9 participants	3 Participants n=261 Participants • Missing data for 9 participants	5 Participants n=268 Participants • Missing data for 9 participants	13 Participants n=791 Participants • Missing data for 9 participants
Use of various types of pain relievers for Back Pain NSAIDs	161 Participants n=266 Participants	155 Participants n=265 Participants	171 Participants n=269 Participants	487 Participants n=800 Participants
Weekly Exercise Other Movement	42 Participants n=266 Participants	39 Participants n=265 Participants	47 Participants n=269 Participants	128 Participants n=800 Participants
Use of various types of pain relievers for Back Pain Acetaminophen	148 Participants n=266 Participants	174 Participants n=265 Participants	162 Participants n=269 Participants	484 Participants n=800 Participants
Use of various types of pain relievers for Back Pain Cannabis	50 Participants n=266 Participants	53 Participants n=265 Participants	59 Participants n=269 Participants	162 Participants n=800 Participants
Use of various types of pain relievers for Back Pain CBD Only	47 Participants n=266 Participants	48 Participants n=265 Participants	42 Participants n=269 Participants	137 Participants n=800 Participants
Use of various types of pain relievers for Back Pain Herbal/Nutritional Supplements	77 Participants n=266 Participants	61 Participants n=265 Participants	81 Participants n=269 Participants	219 Participants n=800 Participants
Weekly Exercise Active Exercise	179 Participants n=266 Participants	190 Participants n=265 Participants	195 Participants n=269 Participants	564 Participants n=800 Participants
Weekly Exercise Low Back Exercise	116 Participants n=266 Participants	137 Participants n=265 Participants	128 Participants n=269 Participants	381 Participants n=800 Participants
Weekly Exercise (number of days) Weekly active exercise	3.1 Days STANDARD_DEVIATION 2.7 • n=266 Participants	3.24 Days STANDARD_DEVIATION 2.7 • n=265 Participants	3.25 Days STANDARD_DEVIATION 2.6 • n=269 Participants	3.2 Days STANDARD_DEVIATION 2.7 • n=800 Participants
Weekly Exercise (number of days) Weekly low back exercise	2.02 Days STANDARD_DEVIATION 2.6 • n=266 Participants	2.13 Days STANDARD_DEVIATION 2.6 • n=265 Participants	2.19 Days STANDARD_DEVIATION 2.7 • n=269 Participants	2.12 Days STANDARD_DEVIATION 2.7 • n=800 Participants
Weekly Exercise (number of days) Weekly other movement	.56 Days STANDARD_DEVIATION 1.6 • n=266 Participants	.42 Days STANDARD_DEVIATION 1.3 • n=265 Participants	.48 Days STANDARD_DEVIATION 1.4 • n=269 Participants	.49 Days STANDARD_DEVIATION 1.5 • n=800 Participants
3+ Days/Week of Exercise 3+ Days of Active Exercise	145 Participants n=266 Participants	146 Participants n=265 Participants	157 Participants n=269 Participants	448 Participants n=800 Participants
3+ Days/Week of Exercise 3+ Days of Low Back Exercise	95 Participants n=266 Participants	98 Participants n=265 Participants	101 Participants n=269 Participants	294 Participants n=800 Participants
3+ Days/Week of Exercise 3+ Days of Other Movement	25 Participants n=266 Participants	21 Participants n=265 Participants	21 Participants n=269 Participants	67 Participants n=800 Participants
Roland Morris Disability Questionnaire Revised (RMDQ-R) - Back-Related Dysfunction (>=18 score) Roland Score >=18	59 Participants n=266 Participants	70 Participants n=265 Participants	67 Participants n=269 Participants	196 Participants n=800 Participants
Roland Morris Disability Questionnaire Revised (RMDQ-R) - Back-Related Dysfunction (>=18 score) Roland Score <18	207 Participants n=266 Participants	195 Participants n=265 Participants	202 Participants n=269 Participants	604 Participants n=800 Participants

PRIMARY outcome

Timeframe: Baseline to 6-month

Population: Participants were individuals \>= 65 years of age with non-specific chronic low back pain (cLMP) persisting for \>=3 months with pain-related interference (\>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment.

Outcome measures

Outcome measures
Measure	Standard Acupuncture n=265 Participants Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Enhanced Acupuncture n=269 Participants Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Usual Care n=266 Participants Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study.
Change in Back-related Disability at 6-month Post Randomization (Continuous)	-3.1 change in score from baseline on scale Interval -3.7 to -2.5	-3.6 change in score from baseline on scale Interval -4.3 to -3.0	-2.1 change in score from baseline on scale Interval -2.7 to -1.5

SECONDARY outcome

Timeframe: Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months

Change in back-related disability is defined as score change in RMDQ, a 24-item questionnaire which asked whether 24 specific activities were limited due to back pain during the past week. The RMDQ is scored from 0 to 24, with higher scores indicating more disability. Greater change between baseline and 3-months or 12-months would indicate greater improvement.

Outcome measures

Outcome measures
Measure	Standard Acupuncture n=265 Participants Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Enhanced Acupuncture n=269 Participants Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Usual Care n=266 Participants Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study.
Change in Back-related Disability at 3-, and 12-month (Continuous) 12 Months	-3.0 score change from baseline on a scale Interval -3.5 to -2.5	-3.5 score change from baseline on a scale Interval -4.2 to -2.8	-1.8 score change from baseline on a scale Interval -2.5 to -1.1
Change in Back-related Disability at 3-, and 12-month (Continuous) 3 Months	-3.4 score change from baseline on a scale Interval -3.8 to -3.0	-3.4 score change from baseline on a scale Interval -3.8 to -3.0	-2.0 score change from baseline on a scale Interval -2.6 to -1.4

SECONDARY outcome

Timeframe: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months

The MCID is measured by a 30% improvement (reduction) on the Roland Morris Disability Questionnaire Revised (RMDQ-R). The MCID reflects clinical improvement and estimates the percentage of individuals with a 30% improvement by intervention arm and 95% confidence intervals are adjusted means of a binary variables estimated using modified Poisson regression. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6. doi: 10.1093/aje/kwh090. PMID: 15033648.

Outcome measures

Outcome measures
Measure	Standard Acupuncture n=265 Participants Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Enhanced Acupuncture n=269 Participants Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Usual Care n=266 Participants Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study.
Achieving Minimal Clinically Important Difference (MCID) in Back-related Disability at 3-, 6-, and 12-months (Binary) 3 Months	42.0 adjusted percentage of participants Interval 38.0 to 46.4	42.0 adjusted percentage of participants Interval 38.0 to 46.4	29.9 adjusted percentage of participants Interval 24.9 to 36.0
Achieving Minimal Clinically Important Difference (MCID) in Back-related Disability at 3-, 6-, and 12-months (Binary) 6 Months	39.1 adjusted percentage of participants Interval 33.1 to 46.1	43.8 adjusted percentage of participants Interval 38.0 to 50.4	29.4 adjusted percentage of participants Interval 24.3 to 35.5
Achieving Minimal Clinically Important Difference (MCID) in Back-related Disability at 3-, 6-, and 12-months (Binary) 12 Months	37.7 adjusted percentage of participants Interval 33.6 to 42.3	43.8 adjusted percentage of participants Interval 39.0 to 49.2	28.4 adjusted percentage of participants Interval 23.4 to 34.4

SECONDARY outcome

Timeframe: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months

Change in pain intensity and pain interference with enjoyment of life and general activity will be measured by PEG, a 3-item pain-intensity and pain-related interference composite measure assessing pain intensity, and pain interference with enjoyment of life and general activity. Each item is measured by a 0 to 10 scale with 10 indicating greater pain intensity or pain interference. The scores are then averaged with a higher average score indicating greater pain interference/intensity.

Outcome measures

Outcome measures
Measure	Standard Acupuncture n=265 Participants Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Enhanced Acupuncture n=269 Participants Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Usual Care n=266 Participants Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study.
Change in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (Continuous) 6 Months	-1.1 change of score from baseline on a scale Interval -1.3 to -0.8	-1.5 change of score from baseline on a scale Interval -1.8 to -1.3	-0.6 change of score from baseline on a scale Interval -0.9 to -0.3
Change in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (Continuous) 3 Months	-1.4 change of score from baseline on a scale Interval -1.5 to -1.3	-1.4 change of score from baseline on a scale Interval -1.5 to -1.3	-0.6 change of score from baseline on a scale Interval -0.8 to -0.4
Change in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (Continuous) 12 Months	-1.1 change of score from baseline on a scale Interval -1.3 to -0.9	-1.3 change of score from baseline on a scale Interval -1.5 to -1.1	-0.7 change of score from baseline on a scale Interval -0.9 to -0.4

SECONDARY outcome

Timeframe: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months

The MCID is measured by a 30% improvement (reduction) on the PEG. The MCID reflects clinical improvement and estimates the percentage of individuals with a 30% improvement by intervention arm and 95% confidence intervals are adjusted means of a binary variables estimated using modified Poisson regression. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6. doi: 10.1093/aje/kwh090. PMID: 15033648.

Outcome measures

Outcome measures
Measure	Standard Acupuncture n=265 Participants Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Enhanced Acupuncture n=269 Participants Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Usual Care n=266 Participants Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study.
Achieving MCID in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (Binary) 3 Months	41.1 adjusted percentage of participants Interval 37.6 to 44.9	41.1 adjusted percentage of participants Interval 37.6 to 44.9	23.3 adjusted percentage of participants Interval 18.7 to 29.1
Achieving MCID in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (Binary) 6 Months	35.0 adjusted percentage of participants Interval 30.5 to 40.2	40.5 adjusted percentage of participants Interval 35.6 to 46.1	29.4 adjusted percentage of participants Interval 24.4 to 35.5
Achieving MCID in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (Binary) 12 Months	35.9 adjusted percentage of participants Interval 31.3 to 41.0	35.8 adjusted percentage of participants Interval 30.4 to 42.2	29.5 adjusted percentage of participants Interval 24.5 to 35.5

SECONDARY outcome

Timeframe: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months

Change in the Patient-Reported Outcomes Measurement and Information System (PROMIS) Physical functioning short form 6b from the PROMIS-29 (6 items). The 6-item Physical function scale measures self-reported ability to perform activities rather than the actual performance of those activities. Each question has five response options, ranging from one to five. Raw scores range from 6 to 30, with higher scores indicating greater ability. The scores are then standardized using a T-score metric in which 50 is the reference mean and 10 is the standard deviation (SD) of that population.

Outcome measures

Outcome measures
Measure	Standard Acupuncture n=265 Participants Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Enhanced Acupuncture n=269 Participants Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Usual Care n=266 Participants Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study.
Change in Physical Functioning at 3-, 6- and 12-month (Continuous) 3 Months	1.6 change in score from baseline on a scale Interval 1.2 to 2.1	1.6 change in score from baseline on a scale Interval 1.2 to 2.1	0.8 change in score from baseline on a scale Interval 0.1 to 1.4
Change in Physical Functioning at 3-, 6- and 12-month (Continuous) 6 Months	1.2 change in score from baseline on a scale Interval 0.6 to 1.8	1.8 change in score from baseline on a scale Interval 1.2 to 2.5	1.0 change in score from baseline on a scale Interval 0.4 to 1.7
Change in Physical Functioning at 3-, 6- and 12-month (Continuous) 12 Months	1.7 change in score from baseline on a scale Interval 1.0 to 2.3	1.5 change in score from baseline on a scale Interval 0.9 to 2.0	1.0 change in score from baseline on a scale Interval 0.3 to 1.7

SECONDARY outcome

Timeframe: Study primary outcome timepoint: 6 months; Test of Standard Acupuncture: 3 months; Test of Maintenance effect: 12 months

Patient Global Impression of Change in Overall Pain (1 item). This is a 0 to 6 scale ranging from much worse to much better, with higher scores indicating more improvement.

Outcome measures

Outcome measures
Measure	Standard Acupuncture n=265 Participants Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Enhanced Acupuncture n=269 Participants Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Usual Care n=266 Participants Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study.
Patient Global Impression of Change (PGIC) at 3-, 6-, and 12- Months 3 Months	4.5 Change in score from baseline on a scale Interval 4.4 to 4.6	4.5 Change in score from baseline on a scale Interval 4.4 to 4.6	3.4 Change in score from baseline on a scale Interval 3.2 to 3.5
Patient Global Impression of Change (PGIC) at 3-, 6-, and 12- Months 6 Months	4.0 Change in score from baseline on a scale Interval 3.8 to 4.1	4.6 Change in score from baseline on a scale Interval 4.4 to 4.7	3.3 Change in score from baseline on a scale Interval 3.1 to 3.5
Patient Global Impression of Change (PGIC) at 3-, 6-, and 12- Months 12 Months	3.9 Change in score from baseline on a scale Interval 3.7 to 4.1	4.1 Change in score from baseline on a scale Interval 4.0 to 4.3	3.3 Change in score from baseline on a scale Interval 3.1 to 3.6

SECONDARY outcome

Timeframe: SAE: 12 months from electronic health record data; AE: 12 months from acupuncture treatment records and follow-up interviews.

Serious adverse events were defined as hospitalizations and deaths. Only potentially treatment-related non-serious adverse events were reported in the acupuncture arms (not usual care).

Outcome measures

Outcome measures
Measure	Standard Acupuncture n=265 Participants Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Enhanced Acupuncture n=269 Participants Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Usual Care n=266 Participants Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study.
Serious Adverse Effects (SAE)/Non-Serious Adverse Effects (AE) Adverse Events (AEs)	24 events	27 events	0 events
Serious Adverse Effects (SAE)/Non-Serious Adverse Effects (AE) Serious Adverse Events (SAEs)	24 events	24 events	18 events

OTHER_PRE_SPECIFIED outcome

Timeframe: Study primary outcome timepoint: Baseline to 6 months (sleep quality)

Change in sleep quality is measured by the six-item Patient-Reported Outcomes Measurement and Information System (PROMIS) Sleep Disturbance Short Form 6a. The raw computed score has a range of 6-30 with higher scores indicating more sleep disturbance. The raw score is converted to a T-score with mean of 50, standard deviation of 10. Higher T-scores indicate worse sleep quality. PROMIS Sleep Scoring Manual. Published online June 3, 2022. https://www.healthmeasures.net/images/PROMIS/manuals/Scoring\_Manual\_Only/PROMIS\_Sleep\_Scoring\_Manual\_03June2022.pdf

Outcome measures

Outcome measures
Measure	Standard Acupuncture n=265 Participants Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Enhanced Acupuncture n=269 Participants Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Usual Care n=266 Participants Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study.
Change in Sleep Quality	-1.62 Change in T-score from baseline Interval -2.4 to -0.84	-2.19 Change in T-score from baseline Interval -3.17 to -1.22	-1.18 Change in T-score from baseline Interval -2.14 to -0.22

OTHER_PRE_SPECIFIED outcome

Timeframe: Study primary outcome timepoint: Baseline to 6 months (sleep duration); Test of Standard Acupuncture: Baseline to 3 months (sleep duration only); Test of Maintenance effect: Baseline to 12 months (sleep duration only)

Change in 1-item sleep duration scale for sleep duration.

Outcome measures

Outcome measures
Measure	Standard Acupuncture n=265 Participants Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Enhanced Acupuncture n=269 Participants Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Usual Care n=266 Participants Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study.
Change in Sleep Duration at 3-, 6- and 12-month 12 Months	0.18 change in hours from baseline Interval 0.04 to 0.31	0.27 change in hours from baseline Interval 0.16 to 0.37	0.13 change in hours from baseline Interval -0.1 to 0.27
Change in Sleep Duration at 3-, 6- and 12-month 3 Months	0.17 change in hours from baseline Interval 0.08 to 0.26	0.17 change in hours from baseline Interval 0.08 to 0.26	0.17 change in hours from baseline Interval 0.03 to 0.31
Change in Sleep Duration at 3-, 6- and 12-month 6 Months	0.12 change in hours from baseline Interval 0.0 to 0.25	0.2 change in hours from baseline Interval 0.08 to 0.32	0.02 change in hours from baseline Interval -0.1 to 0.15

OTHER_PRE_SPECIFIED outcome

Timeframe: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months

Change in PRO scores about the frequency of being anxious or having uncontrollable worry over the past two weeks from the GAD-2, which is part of the PHQ-4. Each item is measured by a 0 to 3 scale with 3 indicating greater anxiety. GAD-2 range is 0-6, with 6 being greater anxiety symptoms.

Outcome measures

Outcome measures
Measure	Standard Acupuncture n=265 Participants Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Enhanced Acupuncture n=269 Participants Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Usual Care n=266 Participants Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study.
Change in Symptoms Suggesting Clinically Relevant Anxiety at 3-, 6- and 12-month (Continuous) 12 Months	-0.4 change in score from baseline on a scale Interval -0.5 to -0.3	-0.3 change in score from baseline on a scale Interval -0.4 to -0.1	0.0 change in score from baseline on a scale Interval -0.2 to 0.2
Change in Symptoms Suggesting Clinically Relevant Anxiety at 3-, 6- and 12-month (Continuous) 3 Months	-0.2 change in score from baseline on a scale Interval -0.3 to 0.0	-0.2 change in score from baseline on a scale Interval -0.3 to 0.0	0.0 change in score from baseline on a scale Interval -0.1 to 0.2
Change in Symptoms Suggesting Clinically Relevant Anxiety at 3-, 6- and 12-month (Continuous) 6 Months	-0.3 change in score from baseline on a scale Interval -0.4 to -0.1	-0.2 change in score from baseline on a scale Interval -0.4 to 0.0	0.1 change in score from baseline on a scale Interval -0.2 to 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months

Change in PRO scores about the frequency of depressed mood and anhedonia over the past two weeks from the PHQ-2. Each item is measured by a 0 to 3 scale with 3 indicating greater depression. Total score is 0-6, with 6 indicating greater depression.

Outcome measures

Outcome measures
Measure	Standard Acupuncture n=265 Participants Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Enhanced Acupuncture n=269 Participants Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Usual Care n=266 Participants Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study.
Change in Symptoms Suggesting Depression at 3-, 6- and 12-month (Continuous) 3 Months	-0.2 change in score from baseline on a scale Interval -0.3 to -0.1	-0.2 change in score from baseline on a scale Interval -0.3 to -0.1	0.0 change in score from baseline on a scale Interval -0.2 to 0.1
Change in Symptoms Suggesting Depression at 3-, 6- and 12-month (Continuous) 6 Months	-0.2 change in score from baseline on a scale Interval -0.4 to -0.1	-0.3 change in score from baseline on a scale Interval -0.4 to -0.1	0.0 change in score from baseline on a scale Interval -0.2 to 0.2
Change in Symptoms Suggesting Depression at 3-, 6- and 12-month (Continuous) 12 Months	-0.4 change in score from baseline on a scale Interval -0.5 to -0.3	-0.3 change in score from baseline on a scale Interval -0.4 to -0.2	-0.2 change in score from baseline on a scale Interval -0.4 to -0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months

Change in fatigue will be measured by a change in T-score of the 4-item Patient-Reported Outcomes Measurement and Information System (PROMIS) Fatigue Subscale - SF 4a. This PROMIS measure has a T-score with a mean of 50 and a standard deviation of 10, meaning a score of 50 is average. Higher T-scores indicates greater fatigue. PROMIS Fatigue Scoring Manual. Published online November 4, 2016. https://www.fda.gov/media/137977/download

Outcome measures

Outcome measures
Measure	Standard Acupuncture n=265 Participants Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Enhanced Acupuncture n=269 Participants Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Usual Care n=266 Participants Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study.
Change in Fatigue at 3-, 6- and 12-month (Continuous) 3 Months	-3.27 change in T-score from baseline Interval -4.09 to -2.46	-3.27 change in T-score from baseline Interval -4.09 to -2.46	-2.42 change in T-score from baseline Interval -3.43 to -1.41
Change in Fatigue at 3-, 6- and 12-month (Continuous) 6 Months	-2.06 change in T-score from baseline Interval -3.14 to -0.97	-2.52 change in T-score from baseline Interval -3.69 to -1.35	-1.55 change in T-score from baseline Interval -2.61 to -0.48
Change in Fatigue at 3-, 6- and 12-month (Continuous) 12 Months	-2.47 change in T-score from baseline Interval -3.39 to -1.54	-3.50 change in T-score from baseline Interval -4.26 to -2.74	-1.18 change in T-score from baseline Interval -2.24 to -0.12

OTHER_PRE_SPECIFIED outcome

Timeframe: Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months

Change in ability to engage in social roles will be measured by the 4-item subscale for ability to participate in social roles in PROMIS. PROMIS measures are standard T-score range of 20-80, with higher scores indicating greater ability to engage in social roles.

Outcome measures

Outcome measures
Measure	Standard Acupuncture n=265 Participants Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Enhanced Acupuncture n=269 Participants Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.	Usual Care n=266 Participants Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study.
Change in Ability to Engage in Social Roles at 3-, 6- and 12-month (Continuous) 3 Months	1.6 change in score from baseline on a scale Interval 1.0 to 2.2	1.6 change in score from baseline on a scale Interval 1.0 to 2.2	0.4 change in score from baseline on a scale Interval -0.5 to 1.2
Change in Ability to Engage in Social Roles at 3-, 6- and 12-month (Continuous) 6 Months	1.3 change in score from baseline on a scale Interval 0.5 to 2.1	1.6 change in score from baseline on a scale Interval 0.5 to 2.6	0.5 change in score from baseline on a scale Interval -0.4 to 1.4
Change in Ability to Engage in Social Roles at 3-, 6- and 12-month (Continuous) 12 Months	1.6 change in score from baseline on a scale Interval 0.9 to 2.3	1.4 change in score from baseline on a scale Interval 0.6 to 2.1	-0.2 change in score from baseline on a scale Interval -1.0 to 0.6

Adverse Events

Usual Care

Serious events: 18 serious events

Other events: 0 other events

Deaths: 2 deaths

Standard Acupuncture

Serious events: 24 serious events

Other events: 24 other events

Deaths: 0 deaths

Enhanced Acupuncture

Serious events: 24 serious events

Other events: 27 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Andrea Cook, PhD - Principal Investigator

Kaiser Permanente Washington

Phone: 206-287-4257

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place