Acupuncture/Moxibustion (Acu/Moxa) for Distal Symmetric Peripheral Neuropathy (DSP) in HIV

NCT00826345 | Completed

• 1 other identifier: AAAD3398
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This preliminary study will investigate the use of Acupuncture and Moxibustion (Acu/Moxa) for distal symmetric peripheral neuropathy (DSP) associated with HIV applying traditional Chinese medicine (TCM) evaluations conducted by a diagnostic acupuncturist. The investigators will evaluate the role of Acu/Moxa in reducing the symptoms of DSP related to HIV/AIDS and treatment side effects. The effects of symptom reduction on quality of life will also be examined. This application will establish a proof of principle for the role of Acu/Moxa in the treatment of DSP and provide data that will serve as a foundation for establishing a future larger clinical trial.

Conditions

Peripheral Neuropathy; HIV; AIDS; HIV Infections

Keywords

Peripheral Neuropathy; Neuropathy; HIV; AIDS; DSP; alternative therapies

Outcome Measures

Primary Outcomes (1)

• Symptom diary Gracely Pain Scale

  Baseline, Weekly and Follow-up visits

Secondary Outcomes (1)

• Subjective Peripheral Neuropathy Screen (SPNS) Clinical Global Impression Scale Neurological Assessment Form

  Baseline, weekly and follow-up visits

Study Arms (2)

Acupuncture/Moxibustion

EXPERIMENTAL

Diagnostic Acupuncturists assessments will inform acupuncture/moxibustion treatment prescriptions for persons with HIV/AIDS experiencing distal peripheral neuropathy. This protocol is tailored specifically for the subject's unique diagnosis according to the symptoms being reported at each diagnostic acupuncture (DA) session.

Other: Acupuncture / Moxibustion

Placebo Acupuncture / Moxibustion

PLACEBO COMPARATOR

Sham/placebo Arm: Points will be administered away from the classic/traditional true point location.

Other: Acupuncture/Moxibustion

Interventions

Acupuncture / Moxibustion OTHER

Acupuncture/Moxibustion points will be administered per point prescription. \- Active

Acupuncture/Moxibustion

Acupuncture/Moxibustion OTHER

Sham/Placebo Acupuncture/Moxibustion - Not active

Placebo Acupuncture / 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 HIV positive or CDC defined AIDS diagnosed subjects who are 18 years of age or older, have a history of distal symmetrical peripheral neuropathy of the lower extremities (legs and feet) for two months or greater.
• Experiencing patient rated pain severity at "moderate" on the Gracely pain scale documented in 1 week prospective self report symptom diary.
• Verification from Primary provider of subject's: HIV status, diagnosis of DSP, and their agreement that their patient is clinically suitable for the study.
• Individuals able to successfully complete a mini-mental status exam (obtaining a score of 24 or above).
• Individuals who understand and agree to complete daily symptom diaries for the duration of the study.
• Individuals taking antiretroviral combinations (a) must have completed an initial 8 weeks of a stable regime (same drug(s), dose \& frequency) prior to entry into the study.
• Individuals taking chronic pain medications (b) must be on a stable regime (same drug, dose \& 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 \& 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, B12 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 INH, dapsone or metronidazole within 8 weeks prior to enrollment.

Sponsors & Collaborators

• NYU Langone Health: lead
• Columbia University: collaborator

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Acquired Immunodeficiency Syndrome; HIV Infections

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; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Joyce K Anastasi, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Professor / Director Div. Special Studies in Symptom Management

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 22, 2009
• Study Start: January 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 22, 2012

Record last verified: 2012-06

Locations

US (1)