Acupuncture/Moxibustion (Acu/Moxa) for Distal Symmetric Peripheral Neuropathy (DSP) in HIV - Full Text View

Sponsored by:	Columbia University
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00826345

Purpose

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.

Condition	Intervention
Peripheral Neuropathy HIV AIDS HIV Infections	Other: Acupuncture / Moxibustion Other: Acupuncture/Moxibustion

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Patient-Oriented TCM Intervention for DSP in HIV: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: AIDS Acupuncture Peripheral Nerve Disorders

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

Symptom diary Gracely Pain Scale [ Time Frame: Baseline, Weekly and Follow-up visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subjective Peripheral Neuropathy Screen (SPNS) Clinical Global Impression Scale Neurological Assessment Form [ Time Frame: Baseline, weekly and follow-up visits ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	January 2009
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Acupuncture/Moxibustion points will be administered per point prescription. Active
Placebo Acupuncture / Moxibustion: Placebo Comparator Sham/placebo Arm: Points will be administered away from the classic/traditional true point location.	Other: Acupuncture/Moxibustion Sham/Placebo Acupuncture/Moxibustion - Not active

Detailed Description:

This study is a prospective, randomized, sham/placebo controlled, blinded (subject and evaluator), parallel groups clinical trial. This preliminary study will investigate the use of Acupuncture and Moxibustion (Acu/Moxa) for DSP associated with HIV applying 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. Data from daily symptom diaries and questionnaires will be analyzed with mixed model analysis of variance for between group difference in the temporal pattern of symptom reduction at baseline, after 6 weeks of twice weekly treatment, and after a no-treatment follow-up session. In addition, exploratory analyses will assess the logistics of a CAM clinical trial for HIV/AIDS related DSP in preparation of a larger clinical trial.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826345

Contacts

Contact: Ann Chung	212-365-0346	amc103@columbia.edu
Contact: Colin Scully	212-365-0346

Locations

United States, New York
Columbia University	Recruiting
New York, New York, United States, 10032
Principal Investigator: Joyce K. Anastasi, PhD

Sponsors and Collaborators

Columbia University

Investigators

Principal Investigator:

Joyce K Anastasi, PhD

Columbia University

More Information

No publications provided

Responsible Party:	Columbia University ( Dr. J. K. Anastasi, Director, Center for AIDS Research )
Study ID Numbers:	AAAD3398
Study First Received:	January 21, 2009
Last Updated:	February 25, 2009
ClinicalTrials.gov Identifier:	NCT00826345 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Columbia University:

Peripheral Neuropathy
Neuropathy
HIV

AIDS
DSP
alternative therapies

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Neuromuscular Diseases
HIV Infections
Peripheral Nervous System Diseases

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Nervous System Diseases
Acquired Immunodeficiency Syndrome
Infection
Immunologic Deficiency Syndromes

Virus Diseases
Neuromuscular Diseases
HIV Infections
Peripheral Nervous System Diseases
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on September 11, 2009