Neuropathic PainNCT03855111
Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain
A study testing Standard Acupuncture / Moxibustion and Individualized (Tailored) Active Acupuncture / Moxibustion in people with Neuropathic Pain and HIV Neuropathy, run by New York University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, HIV Neuropathy, HIV/AIDS
- What is being tested?
- Standard Acupuncture / Moxibustion and Individualized (Tailored) Active Acupuncture / Moxibustion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2019to 21 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, 18 years of age or older, HIV+ or AIDS diagnosed, with a history of DSP of the lower extremities for the past three months or greater.
- Primary care provider (PCP) verification of HIV status, diagnosis of DSP, \& subject clinical suitability for the study.
- Evidence of lower limb neuropathy (bilateral ankle reflexes absent or depressed relative to the knee, decreased sensation to vibration, pin prick and temperature with distal sensory loss grading to normal in the proximal limb)
- GPS rated pain severity of "moderate" or above, documented in 1-week prospective self-report symptom diary (SD).
- Any antiretroviral Rx must have 3 months of stable regimen (same drugs, dose \& frequency) prior to enrollment.
- Any pain medications must have 3 months of stable regimen prior to enrollment.
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- Those on a stable pharmacologic regimen are expected to remain on the regimen for the duration of the study.
- Must understand and agree to complete daily symptom diaries for the duration of the study.
- Successfully complete a mini-mental status exam (obtaining a score of 24 or above).
Who cannot join
- Any acute condition requiring medical care (eg. opportunistic infection).
- Conditions that may mimic HIV DSP symptoms: i.e. diabetes(3), coagulopathies, B12 deficiency, etc.
- Use any topically applied medications to the lower extremities.
- Alcohol and/or substance dependence.
- Use of injectable corticosteroids or any medications known to be neurotoxic within 3 months prior to enrollment.
- Pregnant women or unwilling to use an acceptable form of birth control.
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- Receiving acupuncture within 6 months prior to enrollment.
- Any history of receiving moxibustion.
- Currently receiving any other complementary therapies such as herbs, massage, reiki etc.
- Relocation or plans that interfere with attending all of the planned study sessions and/or recording SD information.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University, Division of Special Studies in Symptom Management
New York, New York, 10010
About this study
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.
Read the detailed description
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.
- Conditions
- Neuropathic Pain, HIV Neuropathy, HIV/AIDS, Pain
- Being tested
- Standard Acupuncture / Moxibustion, Individualized (Tailored) Active Acupuncture / Moxibustion
- Keywords
- Neuropathic pain, HIV Neuropathy, HIV/AIDS, Symptom Management, Acupuncture, Pain, Pain Syndrome
- Medical subject headings
- Neuralgia, Acquired Immunodeficiency Syndrome, Pain, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Acupuncture / MoxibustionOther
Also called Standard Acupuncture /Moxibustion
Standard (Fixed) Active Acupuncture / Moxibustion protocol aimed at reducing lower limb neuropathic pain/discomfort.
Individualized (Tailored) Active Acupuncture / MoxibustionOther
Also called Individualized 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard Acupuncture / Moxibustion |
| 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. Receives: Other: Individualized (Tailored) Active Acupuncture / Moxibustion |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Secondary outcomes (5)
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".
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline neurological physical assessment at week 15 (the end of follow-up phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start14 Jan 2019
- Primary completion21 Oct 2024
- Study completion21 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, blinded, placebo-controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855111
- Sponsor's protocol ID
- S18-00257
- Other IDs
- NIH-1R01NR017917-01
- Status last verified
- Sep 2025
- First submitted
- 20 Feb 2019
- Last updated
- 19 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain
- ClinicalTrials.gov ID
- NCT03855111
- Acronym / sponsor ID
- S18-00257
- Conditions
- Neuropathic Pain, HIV Neuropathy, HIV/AIDS, Pain
- Keywords
- Neuropathic pain, HIV Neuropathy, HIV/AIDS, Symptom Management, Acupuncture, Pain, Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 21 Oct 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Posted 19 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, blinded, placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Standard (fixed) protocol Acu/Moxa - Active | Experimental | Other: Standard Acupuncture / MoxibustionStandard (Fixed) Acupuncture / Moxibustion Active Protocol Participants receive active standard Acu/Moxa protocol aimed at reducing neuropathic pain/discomfort. |
| Individualized (tailored) protocol Acu/Moxa - Active | Experimental | Other: Individualized (Tailored) Active Acupuncture / MoxibustionIndividualized (Tailored) Active Acupuncture / Moxibustion Protocol Participants receive active individualized Acu/Moxa protocol based on traditional Chinese medicine assessment aimed reducing neuropathic pain/discomfort. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women, 18 years of age or older, HIV+ or AIDS diagnosed, with a history of DSP of the lower extremities for the past three months or greater.
- Primary care provider (PCP) verification of HIV status, diagnosis of DSP, \& subject clinical suitability for the study.
- Evidence of lower limb neuropathy (bilateral ankle reflexes absent or depressed relative to the knee, decreased sensation to vibration, pin prick and temperature with distal sensory loss grading to normal in the proximal limb)
- GPS rated pain severity of "moderate" or above, documented in 1-week prospective self-report symptom diary (SD).
- Any antiretroviral Rx must have 3 months of stable regimen (same drugs, dose \& frequency) prior to enrollment.
Key exclusion criteria (10 listed)
- Any acute condition requiring medical care (eg. opportunistic infection).
- Conditions that may mimic HIV DSP symptoms: i.e. diabetes(3), coagulopathies, B12 deficiency, etc.
- Use any topically applied medications to the lower extremities.
- Alcohol and/or substance dependence.
- Use of injectable corticosteroids or any medications known to be neurotoxic within 3 months prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Acupuncture / MoxibustionAlso: Standard Acupuncture /MoxibustionStandard (Fixed) Active Acupuncture / Moxibustion protocol aimed at reducing lower limb neuropathic pain/discomfort. | Other | Standard (fixed) protocol Acu/Moxa - Active |
| Individualized (Tailored) Active Acupuncture / MoxibustionAlso: Individualized Active Acupuncture / MoxibustionIndividualized (tailored) protocol Acu/Moxa - Active. Acu/Moxa prescription based on TCM assessment. Protocol aimed at reducing lower limb neuropathic pain/discomfort. | Other | Individualized (tailored) protocol Acu/Moxa - Active |
Primary outcome
Gracely Pain Scale (GPS)
Time frame: 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
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
5 secondary outcomes
Subjective Peripheral Neuropathy Screen (SPNS)
Time frame: 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
NIH PROMIS Pain Scale
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: Change from baseline neurological physical assessment at week 15 (the end of follow-up phase)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Acupuncture / Moxibustion and Individualized (Tailored) Active Acupuncture / Moxibustion in people with Neuropathic Pain and HIV Neuropathy, run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gracely Pain Scale (GPS) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.