Symptom Management Efficacy Study to Reduce Distal Neuropathic Pain

NCT03855111 | Completed DMC

• 2 other identifiers: S18-00257NIH-1R01NR017917-01
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuropathic Pain; HIV Neuropathy; HIV/AIDS; Pain

Keywords

Neuropathic pain; HIV Neuropathy; HIV/AIDS; Symptom Management; Acupuncture; Pain; Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Gracely Pain Scale (GPS)

  The GPS is a Likert magnitude-estimation log-scale of sensory pain. Subjects rate their DSP pain by selecting one of 13 words to describe their average and worst DSP pain. "Nothing"=0 to "Extremely intense"=12

  Change from baseline rating of pain/discomfort (Gracely Pain Scale) after 6 wks of twice-wkly treatment sessions (the end of the treatment phase) and at weeks 9, 11 and 15 (the follow-up phase - determine sustainability).

Secondary Outcomes (5)

• Subjective Peripheral Neuropathy Screen (SPNS)

  Change from baseline rating of neuropathy symptoms after 6 wks of twice-wkly treatment sessions (the end of the treatment phase) and at weeks 9, 11 and 15 (the follow-up phase - determine change and sustainability)

• NIH PROMIS Pain Scale

  Change from baseline rating of pain intensity after 6 wks of twice-wkly treatment sessions (the end of the treatment phase) and at weeks 9, 11 and 15 (the follow-up phase - determine change and sustainability)

• Medical Outcome Survey - HIV (MOS-HIV)

  Change from baseline rating of general health after 6 wks of twice-wkly treatment sessions (the end of the treatment phase) and at weeks 9, 11 and 15 (the follow-up phase - determine change and sustainability)

• Clinical Global Severity Improvement Scale (CGIs)

  Change from baseline rating of pain intensity after 6 wks of twice-wkly treatment sessions (the end of the treatment phase) and at weeks 9, 11 and 15 (the follow-up phase - determine change and sustainability)

• Neurological Sensory Testing (NST)

  Change from baseline neurological physical assessment after 6 wks of twice-wkly treatment sessions (the end of the treatment phase) and at weeks 9, 11 and 15 (the follow-up phase - determine change and sustainability)

Study Arms (4)

Standard (fixed) protocol Acu/Moxa - Active

EXPERIMENTAL

Standard (Fixed) Acupuncture / Moxibustion Active Protocol Subjects receive active standard Acu/Moxa protocol aimed at reducing neuropathic pain/discomfort.

Other: Standard Acupuncture / Moxibustion

Individualized (tailored) protocol Acu/Moxa - Active

EXPERIMENTAL

Individualized (Tailored) Active Acupuncture / Moxibustion Protocol Subjects receive active individualized Acu/Moxa protocol based on traditional Chinese medicine assessment aimed reducing neuropathic pain/discomfort.

Other: Individualized (Tailored) Active Acupuncture / Moxibustion

Sham Acu/Placebo Moxa (Control)

NO INTERVENTION

Sham Acu/Placebo Moxa (Control) Note. All subjects randomized to the Control will be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.

WaitList (Control)

NO INTERVENTION

WaitList (Control) No treatment. Subjects receive all aspects of study participation with the exception of exposure to Acupuncture / Moxibustion. Note. All subjects randomized to the Control will then be offered 12 active protocol acupuncture/ moxibustion treatments, at no cost, at the end of their study participation.

Interventions

Standard Acupuncture / Moxibustion OTHER

Standard (Fixed) Active Acupuncture / Moxibustion protocol aimed at reducing lower limb neuropathic pain/discomfort.

Also known as: Standard Acupuncture /Moxibustion

Standard (fixed) protocol Acu/Moxa - Active

Individualized (Tailored) Active Acupuncture / Moxibustion OTHER

Individualized (tailored) protocol Acu/Moxa - Active. Acu/Moxa prescription based on TCM assessment. Protocol aimed at reducing lower limb neuropathic pain/discomfort.

Also known as: Individualized Active Acupuncture / Moxibustion

Individualized (tailored) protocol Acu/Moxa - Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• New York University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

New York University, Division of Special Studies in Symptom Management

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Neuralgia; Acquired Immunodeficiency Syndrome; Pain; Somatoform Disorders

Interventions

Moxibustion

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, blinded, placebo-controlled clinical trial

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 26, 2019
• Study Start: January 14, 2019
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2024
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After the outcome paper has been published
• Access Criteria: Contact Principal Investigator

Locations

US (1)