Trial Outcomes & Findings for Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain (NCT NCT03855111)
NCT ID: NCT03855111
Last Updated: 2026-05-19
Results Overview
The GPS is a scale of sensory pain. Participants rate their DSP pain by selecting one of 13 words to describe their average and worst DSP pain. Scores on a scale: "Nothing"=0 to "Extremely intense"=12
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
161 participants
Primary outcome timeframe
After 6 weeks of twice-weekly treatment sessions (the end of the treatment phase) and at week 15 (the end of follow up phase). Change from baseline rating of pain/discomfort
Results posted on
2026-05-19
Participant Flow
Participants are recruited using flyers/brochures posted in HIV community-based organizations (CBO), advertisements in newspapers/ magazines with a healthcare section and by informing colleagues (MDs, physician assistants and nurse practitioners) working in the field of HIV in the NYC area.
Of 194 screened participants, 161 met inclusion criteria and were randomized.
Participant milestones
| Measure |
Standard (Fixed) Protocol Acu/Moxa - Active
Standard (Fixed) Acupuncture / Moxibustion Active Protocol
Subjects receive active standard Acu/Moxa protocol aimed at reducing neuropathic pain/discomfort.
Standard Acupuncture / Moxibustion: Standard (Fixed) Active Acupuncture / Moxibustion protocol aimed at reducing lower limb neuropathic pain/discomfort.
|
Individualized (Tailored) Protocol Acu/Moxa - Active
Individualized (Tailored) Active Acupuncture / Moxibustion Protocol
Subjects receive active individualized Acu/Moxa protocol based on traditional Chinese medicine assessment aimed reducing neuropathic pain/discomfort.
Individualized (Tailored) Active Acupuncture / Moxibustion: Individualized (tailored) protocol Acu/Moxa - Active. Acu/Moxa prescription based on TCM assessment. Protocol aimed at reducing lower limb neuropathic pain/discomfort.
|
Sham Acu/Placebo Moxa (Control)
Sham Acu/Placebo Moxa (Control)
Note. All subjects randomized to the Control will be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.
|
WaitList (Control)
WaitList (Control) No treatment. Subjects receive all aspects of study participation with the exception of exposure to Acupuncture / Moxibustion.
Note. All subjects randomized to the Control will then be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.
|
|---|---|---|---|---|
|
Randomized
STARTED
|
54
|
54
|
27
|
26
|
|
Randomized
COMPLETED
|
54
|
54
|
27
|
26
|
|
Randomized
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
After 6 Weeks of Treatment Sessions
STARTED
|
54
|
54
|
27
|
26
|
|
After 6 Weeks of Treatment Sessions
COMPLETED
|
43
|
40
|
23
|
24
|
|
After 6 Weeks of Treatment Sessions
NOT COMPLETED
|
11
|
14
|
4
|
2
|
|
At Week 15 (End of Follow-up)
STARTED
|
43
|
40
|
23
|
24
|
|
At Week 15 (End of Follow-up)
COMPLETED
|
41
|
37
|
22
|
23
|
|
At Week 15 (End of Follow-up)
NOT COMPLETED
|
2
|
3
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomization allocation to groups was 2:2:1:1
Baseline characteristics by cohort
| Measure |
Standard (Fixed) Protocol Acu/Moxa - Active
n=54 Participants
Standard (Fixed) Acupuncture / Moxibustion Active Protocol
Participants receive active standard Acu/Moxa protocol aimed at reducing neuropathic pain/discomfort.
Standard Acupuncture / Moxibustion: Standard (Fixed) Active Acupuncture / Moxibustion protocol aimed at reducing lower limb neuropathic pain/discomfort.
|
Individualized (Tailored) Protocol Acu/Moxa - Active
n=54 Participants
Individualized (Tailored) Active Acupuncture / Moxibustion Protocol
Participants receive active individualized Acu/Moxa protocol based on traditional Chinese medicine assessment aimed reducing neuropathic pain/discomfort.
Individualized (Tailored) Active Acupuncture / Moxibustion: Individualized (tailored) protocol Acu/Moxa - Active. Acu/Moxa prescription based on TCM assessment. Protocol aimed at reducing lower limb neuropathic pain/discomfort.
|
Sham Acu/Placebo Moxa (Control)
n=27 Participants
Sham Acu/Placebo Moxa (Control)
Note. All participants randomized to the Control will be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.
|
WaitList (Control)
n=26 Participants
WaitList (Control) No treatment. Participants receive all aspects of study participation with the exception of exposure to Acupuncture / Moxibustion.
Note. All participants randomized to the Control will then be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.8 Age in years
STANDARD_DEVIATION 8.8 • n=30 Participants
|
59.2 Age in years
STANDARD_DEVIATION 8.8 • n=30 Participants
|
60.9 Age in years
STANDARD_DEVIATION 8.8 • n=60 Participants
|
59.6 Age in years
STANDARD_DEVIATION 9.17 • n=133 Participants
|
59.8 Age in years
STANDARD_DEVIATION 1.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=30 Participants
|
13 Participants
n=30 Participants
|
8 Participants
n=60 Participants
|
9 Participants
n=133 Participants
|
45 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=30 Participants
|
41 Participants
n=30 Participants
|
19 Participants
n=60 Participants
|
17 Participants
n=133 Participants
|
116 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=30 Participants
|
21 Participants
n=30 Participants
|
7 Participants
n=60 Participants
|
2 Participants
n=133 Participants
|
47 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=30 Participants
|
33 Participants
n=30 Participants
|
20 Participants
n=60 Participants
|
24 Participants
n=133 Participants
|
113 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=133 Participants
|
1 Participants
n=21 Participants
|
|
Gracely Pain Scale (GPS)
|
7.79 DSP pain scores on a scale
STANDARD_DEVIATION 1.62 • n=30 Participants
|
7.97 DSP pain scores on a scale
STANDARD_DEVIATION 1.62 • n=30 Participants
|
7.93 DSP pain scores on a scale
STANDARD_DEVIATION 1.61 • n=60 Participants
|
7.94 DSP pain scores on a scale
STANDARD_DEVIATION 1.58 • n=133 Participants
|
7.94 DSP pain scores on a scale
STANDARD_DEVIATION 1.61 • n=21 Participants
|
|
Subjective Peripheral Neuropathy Screen (SPNS) "aching/burning"
|
6.52 DSP neuropathy symptom scores on a scale
STANDARD_DEVIATION 1.69 • n=30 Participants
|
6.86 DSP neuropathy symptom scores on a scale
STANDARD_DEVIATION 1.69 • n=30 Participants
|
6.68 DSP neuropathy symptom scores on a scale
STANDARD_DEVIATION 1.71 • n=60 Participants
|
6.98 DSP neuropathy symptom scores on a scale
STANDARD_DEVIATION 1.78 • n=133 Participants
|
6.74 DSP neuropathy symptom scores on a scale
STANDARD_DEVIATION 1.70 • n=21 Participants
|
|
Subjective Peripheral Neuropathy Screen (SPNS) "pins and needles"
|
6.47 DSP neuropathy symptom scores on a scale
STANDARD_DEVIATION 1.98 • n=30 Participants • Randomization allocation to groups was 2:2:1:1
|
6.50 DSP neuropathy symptom scores on a scale
STANDARD_DEVIATION 1.98 • n=30 Participants • Randomization allocation to groups was 2:2:1:1
|
6.48 DSP neuropathy symptom scores on a scale
STANDARD_DEVIATION 2.08 • n=60 Participants • Randomization allocation to groups was 2:2:1:1
|
6.65 DSP neuropathy symptom scores on a scale
STANDARD_DEVIATION 2.09 • n=133 Participants • Randomization allocation to groups was 2:2:1:1
|
6.51 DSP neuropathy symptom scores on a scale
STANDARD_DEVIATION 2.0 • n=21 Participants • Randomization allocation to groups was 2:2:1:1
|
|
Subjective Peripheral Neuropathy Screen (SPNS) "numbness"
|
6.85 DSP neuropathy symptom scores on a scale
STANDARD_DEVIATION 1.91 • n=30 Participants • Randomization allocation to groups was 2:2:1:1
|
6.45 DSP neuropathy symptom scores on a scale
STANDARD_DEVIATION 1.91 • n=30 Participants • Randomization allocation to groups was 2:2:1:1
|
7.0 DSP neuropathy symptom scores on a scale
STANDARD_DEVIATION 1.92 • n=60 Participants • Randomization allocation to groups was 2:2:1:1
|
6.75 DSP neuropathy symptom scores on a scale
STANDARD_DEVIATION 1.84 • n=133 Participants • Randomization allocation to groups was 2:2:1:1
|
6.73 DSP neuropathy symptom scores on a scale
STANDARD_DEVIATION 1.90 • n=21 Participants • Randomization allocation to groups was 2:2:1:1
|
|
NIH PROMIS Pain Scale
|
47 Participants
n=30 Participants • Randomization allocation to groups was 2:2:1:1
|
43 Participants
n=30 Participants • Randomization allocation to groups was 2:2:1:1
|
22 Participants
n=60 Participants • Randomization allocation to groups was 2:2:1:1
|
24 Participants
n=133 Participants • Randomization allocation to groups was 2:2:1:1
|
136 Participants
n=21 Participants • Randomization allocation to groups was 2:2:1:1
|
|
Medical Outcome Survey - HIV (MOS-HIV) "physical health"
|
32.4 Scores on a scale
STANDARD_DEVIATION 6.61 • n=30 Participants • Randomization allocation to groups was 2:2:1:1
|
30.7 Scores on a scale
STANDARD_DEVIATION 6.61 • n=30 Participants • Randomization allocation to groups was 2:2:1:1
|
31.8 Scores on a scale
STANDARD_DEVIATION 6.76 • n=60 Participants • Randomization allocation to groups was 2:2:1:1
|
30.9 Scores on a scale
STANDARD_DEVIATION 7.14 • n=133 Participants • Randomization allocation to groups was 2:2:1:1
|
31.6 Scores on a scale
STANDARD_DEVIATION 6.7 • n=21 Participants • Randomization allocation to groups was 2:2:1:1
|
|
Medical Outcome Survey - HIV (MOS-HIV) "mental health"
|
47.2 Scores on a scale
STANDARD_DEVIATION 11.02 • n=30 Participants • Randomization allocation to groups was 2:2:1:1
|
45.8 Scores on a scale
STANDARD_DEVIATION 11.02 • n=30 Participants • Randomization allocation to groups was 2:2:1:1
|
52.2 Scores on a scale
STANDARD_DEVIATION 11.43 • n=60 Participants • Randomization allocation to groups was 2:2:1:1
|
46.6 Scores on a scale
STANDARD_DEVIATION 11.73 • n=133 Participants • Randomization allocation to groups was 2:2:1:1
|
47.5 Scores on a scale
STANDARD_DEVIATION 11.3 • n=21 Participants • Randomization allocation to groups was 2:2:1:1
|
|
Clinical Global Severity Improvement Scale (CGIs)
|
51 Participants
n=30 Participants • Randomization allocation to groups was 2:2:1:1 which accounts for differences in group numbers.
|
49 Participants
n=30 Participants • Randomization allocation to groups was 2:2:1:1 which accounts for differences in group numbers.
|
23 Participants
n=60 Participants • Randomization allocation to groups was 2:2:1:1 which accounts for differences in group numbers.
|
25 Participants
n=133 Participants • Randomization allocation to groups was 2:2:1:1 which accounts for differences in group numbers.
|
148 Participants
n=21 Participants • Randomization allocation to groups was 2:2:1:1 which accounts for differences in group numbers.
|
PRIMARY outcome
Timeframe: After 6 weeks of twice-weekly treatment sessions (the end of the treatment phase) and at week 15 (the end of follow up phase). Change from baseline rating of pain/discomfortPopulation: Randomization allocation to groups was 2:2:1:1 which accounts for differences in group numbers. Attrition accounts for group numbers differences.
The GPS is a scale of sensory pain. Participants rate their DSP pain by selecting one of 13 words to describe their average and worst DSP pain. Scores on a scale: "Nothing"=0 to "Extremely intense"=12
Outcome measures
| Measure |
Sham Acu/Placebo Moxa (Control)
n=23 Participants
Sham Acu/Placebo Moxa (Control)
Note. All subjects randomized to the Control will be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.
|
Standard (Fixed) Protocol Acu/Moxa - Active
n=43 Participants
Standard (Fixed) Acupuncture / Moxibustion Active Protocol
Subjects receive active standard Acu/Moxa protocol aimed at reducing neuropathic pain/discomfort.
Standard Acupuncture / Moxibustion: Standard (Fixed) Active Acupuncture / Moxibustion protocol aimed at reducing lower limb neuropathic pain/discomfort.
|
Individualized (Tailored) Protocol Acu/Moxa - Active
n=40 Participants
Individualized (Tailored) Active Acupuncture / Moxibustion Protocol
Subjects receive active individualized Acu/Moxa protocol based on traditional Chinese medicine assessment aimed reducing neuropathic pain/discomfort.
Individualized (Tailored) Active Acupuncture / Moxibustion: Individualized (tailored) protocol Acu/Moxa - Active. Acu/Moxa prescription based on TCM assessment. Protocol aimed at reducing lower limb neuropathic pain/discomfort.
|
WaitList (Control)
n=24 Participants
WaitList (Control) No treatment. Subjects receive all aspects of study participation with the exception of exposure to Acupuncture / Moxibustion.
Note. All subjects randomized to the Control will then be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.
|
|---|---|---|---|---|
|
Gracely Pain Scale (GPS)
After 6 weeks of twice-weekly treatments
|
-2.38 GPS pain score on a scale
Interval -3.44 to -1.32
|
-2.51 GPS pain score on a scale
Interval -3.3 to -1.72
|
-1.96 GPS pain score on a scale
Interval -2.75 to -1.15
|
-0.99 GPS pain score on a scale
Interval -2.04 to 0.05
|
|
Gracely Pain Scale (GPS)
Week 15 final follow up phase
|
-1.73 GPS pain score on a scale
Interval -3.93 to 0.46
|
-3.34 GPS pain score on a scale
Interval -5.47 to -1.21
|
-1.97 GPS pain score on a scale
Interval -4.38 to 0.45
|
-2.09 GPS pain score on a scale
Interval -4.21 to -0.19
|
SECONDARY outcome
Timeframe: After 6 weeks of twice-weekly treatment sessions and at week 15 (the end of follow up phase) Change from baseline rating of neuropathy symptomsPopulation: Randomization allocation to groups was 2:2:1:1 which accounts for differences in group numbers. Attrition accounts for group numbers differences.
Describes neuropathy symptoms eg. "aching/burning", "pins and needles", "numbness" severity of symptoms. The scale is scored from 1 to 10. 1 is "minimal" and 10 is "extreme".
Outcome measures
| Measure |
Sham Acu/Placebo Moxa (Control)
n=23 Participants
Sham Acu/Placebo Moxa (Control)
Note. All subjects randomized to the Control will be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.
|
Standard (Fixed) Protocol Acu/Moxa - Active
n=43 Participants
Standard (Fixed) Acupuncture / Moxibustion Active Protocol
Subjects receive active standard Acu/Moxa protocol aimed at reducing neuropathic pain/discomfort.
Standard Acupuncture / Moxibustion: Standard (Fixed) Active Acupuncture / Moxibustion protocol aimed at reducing lower limb neuropathic pain/discomfort.
|
Individualized (Tailored) Protocol Acu/Moxa - Active
n=40 Participants
Individualized (Tailored) Active Acupuncture / Moxibustion Protocol
Subjects receive active individualized Acu/Moxa protocol based on traditional Chinese medicine assessment aimed reducing neuropathic pain/discomfort.
Individualized (Tailored) Active Acupuncture / Moxibustion: Individualized (tailored) protocol Acu/Moxa - Active. Acu/Moxa prescription based on TCM assessment. Protocol aimed at reducing lower limb neuropathic pain/discomfort.
|
WaitList (Control)
n=24 Participants
WaitList (Control) No treatment. Subjects receive all aspects of study participation with the exception of exposure to Acupuncture / Moxibustion.
Note. All subjects randomized to the Control will then be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.
|
|---|---|---|---|---|
|
Subjective Peripheral Neuropathy Screen (SPNS)
Week 6 SPNS "aching/burning"
|
-1.84 DSP neuropathy symptom scores on a scale
Interval -2.82 to -0.85
|
-1.18 DSP neuropathy symptom scores on a scale
Interval -1.88 to -0.47
|
-1.33 DSP neuropathy symptom scores on a scale
Interval -2.09 to -0.57
|
-0.45 DSP neuropathy symptom scores on a scale
Interval -1.4 to 0.5
|
|
Subjective Peripheral Neuropathy Screen (SPNS)
Week 6 SPNS "pins and needles"
|
-2.32 DSP neuropathy symptom scores on a scale
Interval -3.38 to -1.25
|
-1.12 DSP neuropathy symptom scores on a scale
Interval -1.89 to -0.34
|
-1.36 DSP neuropathy symptom scores on a scale
Interval -2.12 to -0.6
|
-0.65 DSP neuropathy symptom scores on a scale
Interval -1.63 to 0.32
|
|
Subjective Peripheral Neuropathy Screen (SPNS)
Week 6 SPNS "numbness"
|
-1.53 DSP neuropathy symptom scores on a scale
Interval -2.44 to -0.62
|
-1.41 DSP neuropathy symptom scores on a scale
Interval -2.1 to -0.73
|
-1.38 DSP neuropathy symptom scores on a scale
Interval -2.05 to -0.72
|
-0.5 DSP neuropathy symptom scores on a scale
Interval -1.37 to 0.37
|
|
Subjective Peripheral Neuropathy Screen (SPNS)
Week 15 follow up phase SPNS "aching/burning"
|
-0.82 DSP neuropathy symptom scores on a scale
Interval -2.89 to 1.23
|
-1.73 DSP neuropathy symptom scores on a scale
Interval -3.38 to -0.07
|
-0.74 DSP neuropathy symptom scores on a scale
Interval -3.15 to 1.67
|
-1.17 DSP neuropathy symptom scores on a scale
Interval -3.23 to 0.89
|
|
Subjective Peripheral Neuropathy Screen (SPNS)
Week 15 SPNS "pins and needles"
|
-1.03 DSP neuropathy symptom scores on a scale
Interval -3.26 to 1.21
|
-2.25 DSP neuropathy symptom scores on a scale
Interval -4.22 to -0.27
|
-2.55 DSP neuropathy symptom scores on a scale
Interval -4.79 to -0.31
|
-0.46 DSP neuropathy symptom scores on a scale
Interval -2.87 to 1.94
|
|
Subjective Peripheral Neuropathy Screen (SPNS)
Week 15 SPNS "numbness"
|
-0.84 DSP neuropathy symptom scores on a scale
Interval -3.02 to 1.33
|
-2.06 DSP neuropathy symptom scores on a scale
Interval -3.28 to -0.3
|
-1.32 DSP neuropathy symptom scores on a scale
Interval -3.87 to 1.23
|
-1.41 DSP neuropathy symptom scores on a scale
Interval -3.37 to 0.55
|
SECONDARY outcome
Timeframe: Change from baseline rating of pain intensity after 6 weeks of twice-weekly treatment sessions (the end of the treatment phase) and at week 15 (the end follow-up phase)Population: Randomization allocation to groups was 2:2:1:1 which accounts for differences in group numbers. Attrition accounts for group numbers differences.
NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity short form is used to assess "how much a person hurts". Pain intensity scale score from none (=1) to very severe (=5). Pain intensity rating change from baseline. Negative values (-) indicate pain improvement. Positive (+) values indicate worsening.
Outcome measures
| Measure |
Sham Acu/Placebo Moxa (Control)
n=23 Participants
Sham Acu/Placebo Moxa (Control)
Note. All subjects randomized to the Control will be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.
|
Standard (Fixed) Protocol Acu/Moxa - Active
n=43 Participants
Standard (Fixed) Acupuncture / Moxibustion Active Protocol
Subjects receive active standard Acu/Moxa protocol aimed at reducing neuropathic pain/discomfort.
Standard Acupuncture / Moxibustion: Standard (Fixed) Active Acupuncture / Moxibustion protocol aimed at reducing lower limb neuropathic pain/discomfort.
|
Individualized (Tailored) Protocol Acu/Moxa - Active
n=40 Participants
Individualized (Tailored) Active Acupuncture / Moxibustion Protocol
Subjects receive active individualized Acu/Moxa protocol based on traditional Chinese medicine assessment aimed reducing neuropathic pain/discomfort.
Individualized (Tailored) Active Acupuncture / Moxibustion: Individualized (tailored) protocol Acu/Moxa - Active. Acu/Moxa prescription based on TCM assessment. Protocol aimed at reducing lower limb neuropathic pain/discomfort.
|
WaitList (Control)
n=24 Participants
WaitList (Control) No treatment. Subjects receive all aspects of study participation with the exception of exposure to Acupuncture / Moxibustion.
Note. All subjects randomized to the Control will then be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.
|
|---|---|---|---|---|
|
NIH PROMIS Pain Scale
After 6 weeks of twice-weekly treatment sessions
|
-0.40 Score on rating scale
Interval -0.9 to 0.1
|
-0.82 Score on rating scale
Interval -1.19 to -0.45
|
-0.65 Score on rating scale
Interval -1.04 to -0.27
|
-0.50 Score on rating scale
Interval -0.98 to -0.01
|
|
NIH PROMIS Pain Scale
Week 15 final follow up phase
|
-0.44 Score on rating scale
Interval -0.95 to 0.07
|
-0.79 Score on rating scale
Interval -1.16 to -0.42
|
-0.72 Score on rating scale
Interval -1.1 to -0.33
|
-0.42 Score on rating scale
Interval -0.92 to 0.09
|
SECONDARY outcome
Timeframe: Change from baseline rating of general health after 6 weeks of twice-weekly treatment sessions (the end of the treatment phase) and at week15 (the follow-up phase)Population: Randomization allocation to groups was 2:2:1:1 which accounts for differences in group numbers. Attrition accounts for group numbers differences.
The MOS-HIV is a general health-related quality of life questions in HIV dimensions of health. The MOS-HIV physical health and mental health subscales assess health status on a scale of: 0 to 100 with a mean of 50 and standard deviation of 15. Change in scale scores from baseline values are reported. Positive values indicate improvement. Negative values indicate worsening.
Outcome measures
| Measure |
Sham Acu/Placebo Moxa (Control)
n=23 Participants
Sham Acu/Placebo Moxa (Control)
Note. All subjects randomized to the Control will be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.
|
Standard (Fixed) Protocol Acu/Moxa - Active
n=43 Participants
Standard (Fixed) Acupuncture / Moxibustion Active Protocol
Subjects receive active standard Acu/Moxa protocol aimed at reducing neuropathic pain/discomfort.
Standard Acupuncture / Moxibustion: Standard (Fixed) Active Acupuncture / Moxibustion protocol aimed at reducing lower limb neuropathic pain/discomfort.
|
Individualized (Tailored) Protocol Acu/Moxa - Active
n=40 Participants
Individualized (Tailored) Active Acupuncture / Moxibustion Protocol
Subjects receive active individualized Acu/Moxa protocol based on traditional Chinese medicine assessment aimed reducing neuropathic pain/discomfort.
Individualized (Tailored) Active Acupuncture / Moxibustion: Individualized (tailored) protocol Acu/Moxa - Active. Acu/Moxa prescription based on TCM assessment. Protocol aimed at reducing lower limb neuropathic pain/discomfort.
|
WaitList (Control)
n=24 Participants
WaitList (Control) No treatment. Subjects receive all aspects of study participation with the exception of exposure to Acupuncture / Moxibustion.
Note. All subjects randomized to the Control will then be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.
|
|---|---|---|---|---|
|
Medical Outcome Survey - HIV (MOS-HIV)
Week 6 MOS-HIV Mental health rating
|
3.63 Scores on physical health rating scale
Interval -2.33 to 9.6
|
1.00 Scores on physical health rating scale
Interval -3.51 to 5.5
|
5.09 Scores on physical health rating scale
Interval 0.71 to 9.47
|
1.30 Scores on physical health rating scale
Interval -4.86 to 7.45
|
|
Medical Outcome Survey - HIV (MOS-HIV)
Week 15 follow up phase MOS-HIV Mental health rating
|
2.34 Scores on physical health rating scale
Interval -1.95 to 6.64
|
1.51 Scores on physical health rating scale
Interval -1.65 to 4.67
|
4.49 Scores on physical health rating scale
Interval 1.2 to 7.78
|
1.74 Scores on physical health rating scale
Interval -2.48 to 5.95
|
|
Medical Outcome Survey - HIV (MOS-HIV)
After 6 weeks of twice-weekly treatments
|
4.39 Scores on physical health rating scale
Interval 0.6 to 8.18
|
3.60 Scores on physical health rating scale
Interval 0.74 to 6.64
|
4.21 Scores on physical health rating scale
Interval 1.43 to 6.99
|
2.14 Scores on physical health rating scale
Interval -1.77 to 5.86
|
|
Medical Outcome Survey - HIV (MOS-HIV)
Week 15 final follow up phase
|
4.75 Scores on physical health rating scale
Interval 1.15 to 8.36
|
4.13 Scores on physical health rating scale
Interval 1.5 to 6.75
|
4.85 Scores on physical health rating scale
Interval 2.12 to 7.59
|
3.62 Scores on physical health rating scale
Interval 0.06 to 7.18
|
SECONDARY outcome
Timeframe: Change from baseline rating of pain intensity after 6 weeks of twice-weekly treatment sessions (the end of the treatment phase) and at 15 (the end of follow-up phase)Population: Randomization allocation to groups was 2:2:1:1 which accounts for differences in group numbers. Attrition accounts for group numbers differences. Note: WaitList Arm did not receive treatment therefore the improvement measure was not collected for WaitList participants.
The CGI severity of illness scale measures global severity of symptoms \[in the context of peripheral neuropathy\]. The CGI improvement is recorded at timepoints after baseline as a means to assess benefit. The participant rates severity of peripheral neuropathy on a scale of 0= No discomfort to 6= Very severe discomfort. For the CGI Pain Severity scale, we report the count and percentage of participants in each group who report moderately severe (4) or greater severity. The participant rates improvement on a scale of (6) = great improvement to (0) no improvement. CGI Severity and CGI Improvement are both expressed as the participant count and percent of each group. We analyzed the proportion of participants in each group in categories of improved, unchanged or worsened severity ratings or improvement ratings. For the CGI Pain Improvement scale, we report the count and percentage of participants in each group who report 3 or more levels of improvement.
Outcome measures
| Measure |
Sham Acu/Placebo Moxa (Control)
n=27 Participants
Sham Acu/Placebo Moxa (Control)
Note. All subjects randomized to the Control will be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.
|
Standard (Fixed) Protocol Acu/Moxa - Active
n=54 Participants
Standard (Fixed) Acupuncture / Moxibustion Active Protocol
Subjects receive active standard Acu/Moxa protocol aimed at reducing neuropathic pain/discomfort.
Standard Acupuncture / Moxibustion: Standard (Fixed) Active Acupuncture / Moxibustion protocol aimed at reducing lower limb neuropathic pain/discomfort.
|
Individualized (Tailored) Protocol Acu/Moxa - Active
n=54 Participants
Individualized (Tailored) Active Acupuncture / Moxibustion Protocol
Subjects receive active individualized Acu/Moxa protocol based on traditional Chinese medicine assessment aimed reducing neuropathic pain/discomfort.
Individualized (Tailored) Active Acupuncture / Moxibustion: Individualized (tailored) protocol Acu/Moxa - Active. Acu/Moxa prescription based on TCM assessment. Protocol aimed at reducing lower limb neuropathic pain/discomfort.
|
WaitList (Control)
n=26 Participants
WaitList (Control) No treatment. Subjects receive all aspects of study participation with the exception of exposure to Acupuncture / Moxibustion.
Note. All subjects randomized to the Control will then be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.
|
|---|---|---|---|---|
|
Clinical Global Severity Improvement Scale
CGIs Pain Severity: Baseline
|
23 Participants
|
51 Participants
|
49 Participants
|
25 Participants
|
|
Clinical Global Severity Improvement Scale
CGIs Pain Severity: Week 6
|
2 Participants
|
8 Participants
|
12 Participants
|
0 Participants
|
|
Clinical Global Severity Improvement Scale
CGIs Pain Severity: Week 15
|
3 Participants
|
8 Participants
|
9 Participants
|
0 Participants
|
|
Clinical Global Severity Improvement Scale
CGIs Pain Improvement: Week 6
|
8 Participants
|
12 Participants
|
11 Participants
|
0 Participants
|
|
Clinical Global Severity Improvement Scale
CGIs Pain Improvement: Week 15
|
6 Participants
|
14 Participants
|
8 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Change from baseline neurological physical assessment at week 15 (the end of follow-up phase)Population: Randomization allocation to groups was 2:2:1:1 which accounts for differences in group numbers. Attrition accounts for group numbers differences.
Neurological assessments with Neuro Sensory Testing (NST) include: sensory testing for lower limb pain and thermal sensation.
Outcome measures
| Measure |
Sham Acu/Placebo Moxa (Control)
n=23 Participants
Sham Acu/Placebo Moxa (Control)
Note. All subjects randomized to the Control will be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.
|
Standard (Fixed) Protocol Acu/Moxa - Active
n=43 Participants
Standard (Fixed) Acupuncture / Moxibustion Active Protocol
Subjects receive active standard Acu/Moxa protocol aimed at reducing neuropathic pain/discomfort.
Standard Acupuncture / Moxibustion: Standard (Fixed) Active Acupuncture / Moxibustion protocol aimed at reducing lower limb neuropathic pain/discomfort.
|
Individualized (Tailored) Protocol Acu/Moxa - Active
n=40 Participants
Individualized (Tailored) Active Acupuncture / Moxibustion Protocol
Subjects receive active individualized Acu/Moxa protocol based on traditional Chinese medicine assessment aimed reducing neuropathic pain/discomfort.
Individualized (Tailored) Active Acupuncture / Moxibustion: Individualized (tailored) protocol Acu/Moxa - Active. Acu/Moxa prescription based on TCM assessment. Protocol aimed at reducing lower limb neuropathic pain/discomfort.
|
WaitList (Control)
n=24 Participants
WaitList (Control) No treatment. Subjects receive all aspects of study participation with the exception of exposure to Acupuncture / Moxibustion.
Note. All subjects randomized to the Control will then be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.
|
|---|---|---|---|---|
|
Neurological Sensory Testing (NST)
NST Heat pain change from baseline to week 15
|
-2.36 Degrees in Celsius
Standard Deviation 4.75
|
-0.75 Degrees in Celsius
Standard Deviation 3.53
|
-1.49 Degrees in Celsius
Standard Deviation 3.97
|
0.67 Degrees in Celsius
Standard Deviation 4.92
|
|
Neurological Sensory Testing (NST)
NST Cold threshold change from baseline to week 15
|
1.10 Degrees in Celsius
Standard Deviation 2.10
|
1.38 Degrees in Celsius
Standard Deviation 2.51
|
1.17 Degrees in Celsius
Standard Deviation 2.34
|
1.27 Degrees in Celsius
Standard Deviation 2.79
|
Adverse Events
Standard (Fixed) Protocol Acu/Moxa - Active
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Individualized (Tailored) Protocol Acu/Moxa - Active
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Sham Acu/Placebo Moxa (Control)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
WaitList (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard (Fixed) Protocol Acu/Moxa - Active
n=54 participants at risk
Standard (Fixed) Acupuncture / Moxibustion Active Protocol
Subjects receive active standard Acu/Moxa protocol aimed at reducing neuropathic pain/discomfort.
|
Individualized (Tailored) Protocol Acu/Moxa - Active
n=54 participants at risk
Individualized (Tailored) Active Acupuncture / Moxibustion Protocol
Subjects receive active individualized Acu/Moxa protocol based on traditional Chinese medicine assessment aimed reducing neuropathic pain/discomfort.
|
Sham Acu/Placebo Moxa (Control)
n=27 participants at risk
Sham Acu/Placebo Moxa (Control)
Note. All subjects randomized to the Control will be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.
|
WaitList (Control)
n=26 participants at risk
WaitList (Control) No treatment. Subjects receive all aspects of study participation with the exception of exposure to Acupuncture / Moxibustion.
Note. All subjects randomized to the Control will then be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.
|
|---|---|---|---|---|
|
General disorders
Complaints of tiredness
|
20.4%
11/54 • Number of events 24 • From enrollment to the end of follow up, up to 15 weeks.
|
3.7%
2/54 • Number of events 3 • From enrollment to the end of follow up, up to 15 weeks.
|
3.7%
1/27 • Number of events 1 • From enrollment to the end of follow up, up to 15 weeks.
|
0.00%
0/26 • From enrollment to the end of follow up, up to 15 weeks.
|
|
Injury, poisoning and procedural complications
Black and blue mark at needle site
|
3.7%
2/54 • Number of events 2 • From enrollment to the end of follow up, up to 15 weeks.
|
11.1%
6/54 • Number of events 9 • From enrollment to the end of follow up, up to 15 weeks.
|
7.4%
2/27 • Number of events 3 • From enrollment to the end of follow up, up to 15 weeks.
|
0.00%
0/26 • From enrollment to the end of follow up, up to 15 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place