NCT03855111Completed
Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 161 (actual)
- First submitted
- 20 Feb 2019
- Start date
- 14 Jan 2019
- Primary completion date
- 21 Oct 2024
- Lead sponsor
- New York University
- Diseases
- HIV
- NCT number
- NCT03855111
What you commit to
- Study type: Interventional
- Participants enrolled: 161
- From 14 Jan 2019 to the primary completion date, 21 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use any topically applied medications to the lower extremities.
- Use of injectable corticosteroids or any medications known to be neurotoxic within 3 months prior to enrollment.
- 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.
Other illness
- Any acute condition requiring medical care (eg. opportunistic infection).
- Conditions that may mimic HIV DSP symptoms: i.e. diabetes(3), coagulopathies, B12 deficiency, etc.
Other
- Alcohol and/or substance dependence.
- Pregnant women or unwilling to use an acceptable form of birth control.
- Relocation or plans that interfere with attending all of the planned study sessions and/or recording SD information.
Who the study is looking for
- 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.
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| New York University, Division of Special Studies in Symptom Management Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.