New hope for HIV nerve pain: Drug-Free relief on the horizon?
NCT ID NCT03855111
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested new non-drug treatments to reduce nerve pain in the feet and legs of people with HIV. 161 adults with HIV-related nerve pain tried these approaches to see if they could ease pain and improve quality of life. The goal was to find better ways to manage this common, painful condition.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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161 people
The number who actually took part.
- Started
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Jan 2019
- Finished
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Oct 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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New York University, Division of Special Studies in Symptom Management
New York, New York, 10010, United States
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