CompletedNot Applicable

Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain

United States161 participantsStarted 2019-01-14

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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). Exclusion Criteria: * 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 neur…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Gracely Pain Scale (GPS)

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

Trial details

NCT IDNCT03855111

SponsorNew York University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-21

Results submitted2026-01-21

View on ClinicalTrials.gov More Neuropathic Pain trials