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| ID | Type | Description | Link |
|---|---|---|---|
| NIH-1R01NR017917-01 | Other Grant/Funding Number | National Institutes of Health |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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Distal sensory peripheral neuropathy (DSP) is a chronic, debilitating painful condition affecting quality of life in persons living with HIV. Treatments prescribed to manage DSP pain, such as nonnarcotic and narcotic analgesics, antidepressants and anticonvulsants, are largely ineffective. In HIV there are no FDA-approved drugs for this indication. This study assesses in a randomized controlled clinical trial, the efficacy of novel non-pharmacologic pain management approaches to reduce HIV-related DSP pain and improve quality of life.
Distal sensory peripheral neuropathy (DSP) is a chronic, debilitating painful condition affecting quality of life in 20%-50% of persons living with HIV. Treatments prescribed to manage DSP pain, such as nonnarcotic and narcotic analgesics, antidepressants and anticonvulsants, are largely ineffective. Effective management of DSP pain is an unmet therapeutic need for this population. This study is a randomized, blinded, placebo-controlled clinical trial of the efficacy of Acupuncture/Moxibustion (Acu/Moxa) for HIV DSP pain/discomfort.
Subjects with HIV-related lower limb DSP pain are randomized to one of four Conditions: 1) Standard (fixed) protocol Acu/Moxa, 2) Individualized (tailored) protocol Acu/Moxa, 3) Sham Acu/Placebo Moxa (control), or 4) WaitList (control). Subjects attend six weeks of twice weekly treatment sessions and 3 non-treatment follow-up sessions at weeks 9, 11, and 15. All subjects are assessed by a blinded diagnostic acupuncturist (DA) and those assigned to Conditions 1, 2 and 3 receive treatments by an unblinded treating acupuncturist (TA). Specific Aims are: #1 determine group differences in weekly average pain (Gracely Pain Scale) at the end of treatment (Tx) and end of follow-up (F/U); SA#2 determine group differences in improvement in specific sensory symptoms (Subjective Peripheral Neuropathy Screen and neurological sensory testing (NST)) and patient-rated effectiveness (Clinical Global Improvement, NIH PROMIS Pain Intensity and Health-Related Quality of Life (MOS-HIV)) at Tx and F/U; SA#3 determine group differences in safety profiles; and SA#4, explore how baseline measures, TCM diagnoses, NST and pain medication use predict response to treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard (fixed) protocol Acu/Moxa - Active | Experimental | Standard (Fixed) Acupuncture / Moxibustion Active Protocol Participants receive active standard Acu/Moxa protocol aimed at reducing neuropathic pain/discomfort. |
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| Individualized (tailored) protocol Acu/Moxa - Active | Experimental | Individualized (Tailored) Active Acupuncture / Moxibustion Protocol Participants receive active individualized Acu/Moxa protocol based on traditional Chinese medicine assessment aimed reducing neuropathic pain/discomfort. |
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| Sham Acu/Placebo Moxa (Control) | No Intervention | 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) | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Acupuncture / Moxibustion | Other | Standard (Fixed) Active Acupuncture / Moxibustion protocol aimed at reducing lower limb neuropathic pain/discomfort. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gracely Pain Scale (GPS) | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Peripheral Neuropathy Screen (SPNS) | 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". | After 6 weeks of twice-weekly treatment sessions and at week 15 (the end of follow up phase) Change from baseline rating of neuropathy symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University, Division of Special Studies in Symptom Management | New York | New York | 10010 | United States |
Congruent with NIH policy, the PI will make any unique resources e.g. the protocol materials developed for this research study be available for research purposes to qualified individuals within the scientific community through publication and presentations. In addition, research information will be made available upon request to Dr. Joyce K. Anastasi.
After the outcome paper has been published
Contact Principal Investigator
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Of 194 screened participants, 161 met inclusion criteria and were randomized.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized |
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| After 6 Weeks of Treatment Sessions |
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| At Week 15 (End of Follow-up) |
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Randomization allocation to groups was 2:2:1:1
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard (Fixed) Protocol Acu/Moxa - Active | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participant age in years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gracely Pain Scale (GPS) | 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 | Randomization allocation to groups was 2:2:1:1 which accounts for differences in group numbers. Attrition accounts for group numbers differences. | Posted | Mean | 95% Confidence Interval | GPS pain score on a scale | 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 |
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From enrollment to the end of follow up, up to 15 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complaints of tiredness | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joyce K. Anastasi | New York University | 212-992-7044 | ja2188@nyu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 20, 2024 | Feb 6, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 20, 2024 | Feb 6, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D000163 | Acquired Immunodeficiency Syndrome |
| D010146 | Pain |
| D013001 | Somatoform Disorders |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D009071 | Moxibustion |
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Randomized, blinded, placebo-controlled clinical trial
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|
| Individualized (Tailored) Active Acupuncture / Moxibustion | Other | Individualized (tailored) protocol Acu/Moxa - Active. Acu/Moxa prescription based on TCM assessment. Protocol aimed at reducing lower limb neuropathic pain/discomfort. |
|
|
| NIH PROMIS Pain Scale | 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. | 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) |
| Medical Outcome Survey - HIV (MOS-HIV) | 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. | 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) |
| Clinical Global Severity Improvement Scale | 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. | 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) |
| Neurological Sensory Testing (NST) | Neurological assessments with Neuro Sensory Testing (NST) include: sensory testing for lower limb pain and thermal sensation. | Change from baseline neurological physical assessment at week 15 (the end of follow-up phase) |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 |
| Individualized (Tailored) Protocol Acu/Moxa - Active |
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. |
| BG002 | Sham Acu/Placebo Moxa (Control) | 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. |
| BG003 | WaitList (Control) | 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. |
| BG004 | Total | Total of all reporting groups |
| Standard Deviation |
| Age in years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Gracely Pain Scale (GPS) | Gracely Pain Scale (GPS) - Rating of DSP pain/discomfort The GPS is a Likert magnitude-estimation log-scale of sensory pain. Subjects rate their DSP pain by selecting one of 13 words to describe their average and worst DSP pain. "Nothing"=0 to "Extremely intense"=12 | Mean | Standard Deviation | DSP pain scores on a scale |
|
| Subjective Peripheral Neuropathy Screen (SPNS) "aching/burning" | Describes neuropathy symptoms eg. "aching/burning", "pins and needles", "numbness" severity of symptoms from "minimal" to "extreme". Rating of neuropathy symptoms | Mean | Standard Deviation | DSP neuropathy symptom scores on a scale |
|
| Subjective Peripheral Neuropathy Screen (SPNS) "pins and needles" | Describes neuropathy symptoms eg. "aching/burning", "pins and needles", "numbness" severity of symptoms from "minimal" to "extreme". Rating of neuropathy symptoms. | Randomization allocation to groups was 2:2:1:1 | Mean | Standard Deviation | DSP neuropathy symptom scores on a scale |
|
| Subjective Peripheral Neuropathy Screen (SPNS) "numbness" | Describes neuropathy symptoms eg. "aching/burning", "pins and needles", "numbness" severity of symptoms from "minimal" to "extreme". Rating of neuropathy symptoms. | Randomization allocation to groups was 2:2:1:1 | Mean | Standard Deviation | DSP neuropathy symptom scores on a scale |
|
| NIH PROMIS Pain Scale | NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity short form is used to assess "how much a person hurts" Count of participants and percentage of group with "moderate" or greater pain intensity on a scale of "1" (no pain) to "5" (very severe pain) | Randomization allocation to groups was 2:2:1:1 | Count of Participants | Participants |
|
| Medical Outcome Survey - HIV (MOS-HIV) "physical health" | 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. Values below the mean indicate poorer health status and values above the mean better health status. | Randomization allocation to groups was 2:2:1:1 | Mean | Standard Deviation | Scores on a scale |
|
| Medical Outcome Survey - HIV (MOS-HIV) "mental health" | 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. Values below the mean indicate poorer health status and values above the mean better health status. | Randomization allocation to groups was 2:2:1:1 | Mean | Standard Deviation | Scores on a scale |
|
| Clinical Global Severity Improvement Scale (CGIs) | The severity of illness scale measures global severity of symptoms [in the context of peripheral neuropathy]. On the severity scale "no discomfort at all" = (0) to "very severe discomfort" = (6). At baseline, we report the count and percent of participants reporting "moderately severe discomfort" = (4) or greater | Randomization allocation to groups was 2:2:1:1 which accounts for differences in group numbers. | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
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| Secondary | Subjective Peripheral Neuropathy Screen (SPNS) | 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". | Randomization allocation to groups was 2:2:1:1 which accounts for differences in group numbers. Attrition accounts for group numbers differences. | Posted | Mean | 95% Confidence Interval | DSP neuropathy symptom scores on a scale | After 6 weeks of twice-weekly treatment sessions and at week 15 (the end of follow up phase) Change from baseline rating of neuropathy symptoms |
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| Secondary | NIH PROMIS Pain Scale | 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. | Randomization allocation to groups was 2:2:1:1 which accounts for differences in group numbers. Attrition accounts for group numbers differences. | Posted | Mean | 95% Confidence Interval | Score on rating scale | 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) |
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| Secondary | Medical Outcome Survey - HIV (MOS-HIV) | 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. | Randomization allocation to groups was 2:2:1:1 which accounts for differences in group numbers. Attrition accounts for group numbers differences. | Posted | Mean | 95% Confidence Interval | Scores on physical health rating scale | 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) |
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| Secondary | Clinical Global Severity Improvement Scale | 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. | 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. | Posted | Count of Participants | Participants | 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) |
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| Secondary | Neurological Sensory Testing (NST) | Neurological assessments with Neuro Sensory Testing (NST) include: sensory testing for lower limb pain and thermal sensation. | Randomization allocation to groups was 2:2:1:1 which accounts for differences in group numbers. Attrition accounts for group numbers differences. | Posted | Mean | Standard Deviation | Degrees in Celsius | Change from baseline neurological physical assessment at week 15 (the end of follow-up phase) |
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| 0 |
| 54 |
| 0 |
| 54 |
| 13 |
| 54 |
| EG001 | 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. | 0 | 54 | 0 | 54 | 8 | 54 |
| EG002 | 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. | 0 | 27 | 0 | 27 | 3 | 27 |
| EG003 | 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. | 0 | 26 | 0 | 26 | 0 | 26 |
| Black and blue mark at needle site | Injury, poisoning and procedural complications | Systematic Assessment |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001523 | Mental Disorders |
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| Week 6 SPNS "pins and needles" |
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| Week 6 SPNS "numbness" |
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| Week 15 follow up phase SPNS "aching/burning" |
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| Week 15 SPNS "pins and needles" |
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| Week 15 SPNS "numbness" |
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| Week 15 final follow up phase |
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| Week 15 final follow up phase |
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| Week 6 MOS-HIV Mental health rating |
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| Week 15 follow up phase MOS-HIV Mental health rating |
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| CGIs Pain Severity: Week 6 |
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| CGIs Pain Severity: Week 15 |
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| CGIs Pain Improvement: Week 6 |
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| CGIs Pain Improvement: Week 15 |
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| NST Cold threshold change from baseline to week 15 |
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