Trial Outcomes & Findings for Validation of the STarT Back Screening Tool in the Military (NCT NCT03127826)
NCT ID: NCT03127826
Last Updated: 2026-06-24
Results Overview
The RMDQ measures low back pain related disability by prompting the participant using 24 statements. The score ranges from 0 to 24 with higher scores indicating greater disability
COMPLETED
NA
290 participants
1 year
2026-06-24
Participant Flow
Participant milestones
| Measure |
Usual Care
* "Managing Low Back Pain" pamphlet from DoD/VA
* No specific guidance regarding physical therapy (PT) or other referrals, thus decision to refer or not will be made by the primary care manager (PCM) according to their preference
|
Risk Stratified Care
* "Managing Low Back Pain" pamphlet from DoD/VA
* Self-management education and tools
* 2-item spinal manipulation screening/delivery if indicated
Low Risk:
* Home Exercise Program as indicated
* No referral for ongoing physical therapy
Medium Risk and High Risk
* Referral to physical therapy for ongoing care at physical therapists discretion
* Managed by a "psychologically informed physical therapy" trained physical therapist
|
|---|---|---|
|
Overall Study
STARTED
|
145
|
145
|
|
Overall Study
COMPLETED
|
145
|
145
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Validation of the STarT Back Screening Tool in the Military
Baseline characteristics by cohort
| Measure |
Usual Care
n=145 Participants
* "Managing Low Back Pain" pamphlet from DoD/VA
* No specific guidance regarding physical therapy (PT) or other referrals, thus decision to refer or not will be made by the primary care manager (PCM) according to their preference
|
Risk Stratified Care
n=145 Participants
* "Managing Low Back Pain" pamphlet from DoD/VA
* Self-management education and tools
* 2-item spinal manipulation screening/delivery if indicated
Low Risk:
* Home Exercise Program as indicated
* No referral for ongoing physical therapy
Medium Risk and High Risk
* Referral to physical therapy for ongoing care at physical therapists discretion
* Managed by a "psychologically informed physical therapy" trained physical therapist
|
Total
n=290 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.6 Years
STANDARD_DEVIATION 8.8 • n=20 Participants
|
34.7 Years
STANDARD_DEVIATION 8.1 • n=20 Participants
|
33.6 Years
STANDARD_DEVIATION 8.8 • n=40 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=20 Participants
|
46 Participants
n=20 Participants
|
94 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=20 Participants
|
99 Participants
n=20 Participants
|
196 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=20 Participants
|
28 Participants
n=20 Participants
|
58 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=20 Participants
|
77 Participants
n=20 Participants
|
157 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
22 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
30 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
42 Participants
n=20 Participants
|
44 Participants
n=20 Participants
|
86 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=20 Participants
|
101 Participants
n=20 Participants
|
204 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Active Duty Service Member
|
118 Participants
n=20 Participants
|
125 Participants
n=20 Participants
|
243 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The primary analysis included individuals with a baseline score AND at least 1 additional time point. This explains the discrepancy between the total that completed the study (N-290) and the number analyzed here (N=270). There were 11 in the usual care group and 9 in the risk-stratified care group that did not have additional scores other than baseline.
The RMDQ measures low back pain related disability by prompting the participant using 24 statements. The score ranges from 0 to 24 with higher scores indicating greater disability
Outcome measures
| Measure |
Usual Care
n=134 Participants
* "Managing Low Back Pain" pamphlet from DoD/VA
* No specific guidance regarding physical therapy (PT) or other referrals, thus decision to refer or not will be made by the primary care manager (PCM) according to their preference
|
Risk Stratified Care
n=136 Participants
* "Managing Low Back Pain" pamphlet from DoD/VA
* Self-management education and tools
* 2-item spinal manipulation screening/delivery if indicated
Low Risk:
* Home Exercise Program as indicated
* No referral for ongoing physical therapy
Medium Risk and High Risk
* Referral to physical therapy for ongoing care at physical therapists discretion
* Managed by a "psychologically informed physical therapy" trained physical therapist
|
|---|---|---|
|
Roland-Morris Disability Questionnaire (RMDQ)
|
5.16 points on a scale
Interval 4.37 to 6.09
|
5.14 points on a scale
Interval 4.36 to 6.07
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The primary analysis included individuals with a baseline score AND at least 1 additional time point. This explains the discrepancy between the total that completed the study (N-290) and the number analyzed here (N=270). There were 11 in the usual care group and 9 in the risk-stratified care group that did not have additional scores other than baseline.
The PROMIS Pain Interference domain provides a T-score based on the population mean of 50 (standard deviation of 10), with higher scores indicating higher pain interference
Outcome measures
| Measure |
Usual Care
n=134 Participants
* "Managing Low Back Pain" pamphlet from DoD/VA
* No specific guidance regarding physical therapy (PT) or other referrals, thus decision to refer or not will be made by the primary care manager (PCM) according to their preference
|
Risk Stratified Care
n=136 Participants
* "Managing Low Back Pain" pamphlet from DoD/VA
* Self-management education and tools
* 2-item spinal manipulation screening/delivery if indicated
Low Risk:
* Home Exercise Program as indicated
* No referral for ongoing physical therapy
Medium Risk and High Risk
* Referral to physical therapy for ongoing care at physical therapists discretion
* Managed by a "psychologically informed physical therapy" trained physical therapist
|
|---|---|---|
|
Patient Reported Outcomes Measurement Information System - Pain Interference
|
51.74 T-Score
Interval 50.41 to 58.74
|
52.50 T-Score
Interval 51.21 to 57.95
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The primary analysis included individuals with a baseline score AND at least 1 additional time point. This explains the discrepancy between the total that completed the study (N-290) and the number analyzed here (N=270). There were 11 in the usual care group and 9 in the risk-stratified care group that did not have additional scores other than baseline.
The EQ-5D is a generic quality of life questionnaire lhat assesses quality of life on a scale that can be referenced to other disease conditions. The EQ-5D covers 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The tool provides a quality of life scores, which is measured by a utility score with 1 representing perfect health and 0 representing a state considered as bad as being dead.
Outcome measures
| Measure |
Usual Care
n=134 Participants
* "Managing Low Back Pain" pamphlet from DoD/VA
* No specific guidance regarding physical therapy (PT) or other referrals, thus decision to refer or not will be made by the primary care manager (PCM) according to their preference
|
Risk Stratified Care
n=137 Participants
* "Managing Low Back Pain" pamphlet from DoD/VA
* Self-management education and tools
* 2-item spinal manipulation screening/delivery if indicated
Low Risk:
* Home Exercise Program as indicated
* No referral for ongoing physical therapy
Medium Risk and High Risk
* Referral to physical therapy for ongoing care at physical therapists discretion
* Managed by a "psychologically informed physical therapy" trained physical therapist
|
|---|---|---|
|
EuroQoL (EQ-5D)
|
0.845 Utility Score on a scale from 0 to 1
Interval 0.829 to 0.862
|
0.854 Utility Score on a scale from 0 to 1
Interval 0.838 to 0.87
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsLow back pain-related costs in the one year after enrollment
Outcome measures
| Measure |
Usual Care
n=145 Participants
* "Managing Low Back Pain" pamphlet from DoD/VA
* No specific guidance regarding physical therapy (PT) or other referrals, thus decision to refer or not will be made by the primary care manager (PCM) according to their preference
|
Risk Stratified Care
n=145 Participants
* "Managing Low Back Pain" pamphlet from DoD/VA
* Self-management education and tools
* 2-item spinal manipulation screening/delivery if indicated
Low Risk:
* Home Exercise Program as indicated
* No referral for ongoing physical therapy
Medium Risk and High Risk
* Referral to physical therapy for ongoing care at physical therapists discretion
* Managed by a "psychologically informed physical therapy" trained physical therapist
|
|---|---|---|
|
Healthcare Utilization - LBP Costs
|
1463 Dollars
Standard Deviation 2283
|
1415 Dollars
Standard Deviation 1581
|
Adverse Events
Usual Care
Risk Stratified Care
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Usual Care
n=145 participants at risk
* "Managing Low Back Pain" pamphlet from DoD/VA
* No specific guidance regarding physical therapy (PT) or other referrals, thus decision to refer or not will be made by the primary care manager (PCM) according to their preference
|
Risk Stratified Care
n=145 participants at risk
* "Managing Low Back Pain" pamphlet from DoD/VA
* Self-management education and tools
* 2-item spinal manipulation screening/delivery if indicated
Low Risk:
* Home Exercise Program as indicated
* No referral for ongoing physical therapy
Medium Risk and High Risk
* Referral to physical therapy for ongoing care at physical therapists discretion
* Managed by a "psychologically informed physical therapy" trained physical therapist
|
|---|---|---|
|
General disorders
ER visit for any reason
|
40.7%
59/145 • up to 1 year
|
50.3%
73/145 • up to 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place