Acupuncture/Moxibustion for Peripheral Neuropathy in HIV - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00317291

Purpose

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).

Condition	Intervention	Phase
Peripheral Neuropathies HIV Infections	Procedure: Acupuncture/Moxibustion	Phase II

MedlinePlus related topics: AIDS Acupuncture Peripheral Nerve Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Acu/Moxa for Peripheral Neuropathy in Persons With HIV

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

Symptom diary
Gracely Pain Scale

Secondary Outcome Measures:

Subjective Peripheral Neuropathy Scale
Clinical Global Impression Scale
Neurological Assessment Form

Estimated Enrollment:	50
Study Start Date:	November 2005
Estimated Study Completion Date:	June 2008

Detailed Description:

Subjects in this early-phase clinical trial will be 50 men and women with HIV infection who have a diagnosis of Distal Symmetric Peripheral neuropathy (DSP). This study is a prospective, randomized, sham/placebo controlled, blinded (subject and evaluator), parallel groups clinical trial. 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 acupuncture/Placebo moxibustion (Sham Acu/Placebo Moxa).

Subjects in Conditions 1 and 2 will attend 16 scheduled sessions over 15 weeks. All subjects will: be blinded/masked to treatment assignments, attend the same number of protocol sessions, be administered the same instruments, and submit their symptom diaries for data entry and analysis. After a screening/intake session, randomization and treatment sessions will follow. 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. The aims of this study include:

To establish the feasibility of the combined Acupuncture/Moxibustion treatment for 6 weeks of twice weekly sessions, in order to reduce the pain related to DSP among persons with HIV/AIDS, and to estimate the effect size of the Acu/Moxa treatment for a future clinical study. Inclusion of 2-, 4-, and 8-week no-treatment follow-up sessions will establish the maintainability of benefit.
To determine the effect of combined Acupuncture/Moxibustion treatment for 6 weeks of twice weekly sessions on reducing symptoms of DSP (aching or burning pain, "pins and needles" sensation, and numbness) among persons with HIV/AIDS.
To determine the effect of the combined Acupuncture/Moxibustion treatment for 6 weeks of twice weekly sessions on patient-perceived DSP symptom improvement and quality of life.
To evaluate the logistics of a CAM clinical trial on persons with HIV/AIDS experiencing DSP.

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 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.

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, 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317291

Contacts

Contact: Ann M Chung	212-305-3041	amc103@columbia.edu
Contact: Debra Narcisse, MSN	212-305-3041

Locations

United States, New York
Columbia University School of Nursing, Acupuncture Laboratory	Recruiting
New York, New York, United States, 10032
Contact: Ann M Chung 212-305-3041 amc103@columbia.edu
Contact: Debra A Narcisse, MSN 212-305-3041
Principal Investigator: Joyce K Anastasi, PhD, DrNP

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Joyce K Anastasi, PhD, DrNP

Columbia University

More Information

Study ID Numbers:	R21 AT003092, AAAB4122
Study First Received:	April 20, 2006
Last Updated:	November 6, 2007
ClinicalTrials.gov Identifier:	NCT00317291
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Acupuncture
HIV
AIDS
Symptom management

Non-invasive
Complementary Therapies
Treatment Experienced

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
Slow Virus Diseases
Immune System Diseases

Nervous System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009