Acupuncture/Moxibustion for Peripheral Neuropathy in HIV

NCT00317291 | Completed Phase 2 DMC

• 2 other identifiers: R21AT003092AAAB4122
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a sample-size-limited, randomized, blinded (subject and evaluator), sham acupuncture/placebo moxibustion (sham acu/placebo moxa) controlled clinical trial. The subjects in this study will be 50 men and women with HIV infection who have a diagnosis of distal symmetric peripheral neuropathy (DSP). Subjects will be randomized to one of two experimental intervention conditions:

• Condition 1: subjects receive acu/moxa treatment; and
• Condition 2 (Control Group): subjects receive sham acu/placebo moxa. All subjects in Conditions 1 and 2 will attend 16 scheduled sessions over 15 weeks, be administered the same instruments, and submit their daily symptom diaries for analysis. There will be six weeks of twice weekly treatment sessions, and three follow-up sessions at weeks 9, 11, and 15. All conditions will be identical in duration and be administered by licensed acupuncturists trained in traditional Chinese medicine (TCM).

Conditions

Peripheral Neuropathies; HIV Infections

Keywords

Acupuncture; HIV; AIDS; Symptom management; Non-invasive; Complementary Therapies; Treatment Experienced

Outcome Measures

Primary Outcomes (2)

• Symptom diary

• Gracely Pain Scale

Secondary Outcomes (3)

• Subjective Peripheral Neuropathy Scale

• Clinical Global Impression Scale

• Neurological Assessment Form

Study Arms (2)

Acupuncture/Moxibustion

EXPERIMENTAL

Acupuncture/Moxibustion for Peripheral Neuropathy in HIV

Procedure: Acupuncture/Moxibustion

Sham acupuncture/Placebo moxibustion

SHAM COMPARATOR

Sham acupuncture/Placebo moxibustion for Peripheral Neuropathy in HIV

Other: Sham acupuncture/Placebo moxibustion

Interventions

Acupuncture/Moxibustion PROCEDURE

Acupuncture/Moxibustion: 16 scheduled sessions

Acupuncture/Moxibustion

Sham acupuncture/Placebo moxibustion OTHER

Sham acupuncture/Placebo moxibustion: 16 scheduled sessions

Sham acupuncture/Placebo moxibustion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women who are HIV positive or Centers for Disease Control (CDC)-defined AIDS diagnosed subjects who are 18 years of age or older, and have a history of distal symmetrical peripheral neuropathy of the lower extremities (legs and feet) for two months or greater.
• Patients experiencing moderate pain severity.
• Verification from primary provider of subject's: HIV status, diagnosis of DSP, and agreement that patient is clinically suitable for the study.
• Individuals able to successfully complete a mini-mental status exam.
• Individuals who understand and agree to complete daily symptom diaries for the duration of the study.
• Individuals taking antiretroviral combinations must have completed an initial 8 weeks of a stable regime (same drug\[s\], dose, and frequency) prior to entry into the study.
• Individuals taking chronic pain medications must be on a stable regime (same drug, dose, and frequency) for at least twenty-one (21) days prior to entry into the study.
• Individuals on all other medications which may have neuropathy listed as a side effect must be on a stable regime (same drug\[s\], dose, and frequency) for at least 21 days prior to entry in the study.

You may not qualify if:

• Individuals with an acute medical condition, i.e. pneumocystis carinii pneumonia, tuberculosis, and/or other opportunistic infections or conditions that would require medical attention.
• Individuals with diagnosis of diabetes mellitus, B-12 deficiency
• Topically applied medications to the lower extremities.
• Individuals with alcohol and/or substance dependence.
• Individuals with bleeding tendency
• Currently receiving treatment with corticosteroids
• Use of isoniazid (INH), dapsone, or metronidazole within 8 weeks prior to enrollment.
• Severe heart disease, uncontrolled high blood pressure, lung disease, or renal failure.
• Pregnant women
• Individuals receiving acupuncture currently and less than 6 months prior to enrollment.
• Individuals with a history of receiving moxibustion.
• Individuals currently receiving other types of complementary therapies such as herbs, massage, reiki, etc.
• Individuals with plans for travel, lifestyle change, or other activity that would preclude attending all of the planned study sessions and/or recording daily diary information.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

Columbia University School of Nursing, Acupuncture Laboratory

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Acupuncture Therapy; Moxibustion

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Joyce K Anastasi, PhD, DrNP

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 20, 2006
• First Posted: April 24, 2006
• Study Start: November 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: September 11, 2019

Record last verified: 2009-09

Locations

US (1)