Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    196
  • sponsor
    New York University
Updated on 4 November 2021
analgesics
discomfort
acupuncture
antiretroviral
antidepressants
pain relieving
numbness

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.

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.

Details
Condition ache, Neuralgia, Post-Surgical Pain, neuropathic pain, Acute Pain Service, HIV/AIDS, Pain, HIV Neuropathy, Pain (Pediatric), Peripheral Neuropathy
Treatment Standard Acupuncture / Moxibustion, Individualized (Tailored) Active Acupuncture / Moxibustion
Clinical Study IdentifierNCT03855111
SponsorNew York University
Last Modified on4 November 2021

Eligibility

Yes No Not Sure

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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