Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain

Completed · Not applicable · Has a placebo group

Conditions studied: Neuropathic Pain, HIV Neuropathy, HIV/AIDS, Pain

In brief

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.

Key facts

Study ID

NCT03855111

Run by

New York University

People needed

161

Starts

2019-01-14

Expected to finish

2024-10-21

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.
• 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.

Where it is running

• New York University, Division of Special Studies in Symptom Management — New York, New York, United States

Full record on ClinicalTrials.gov

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