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

Completed · Not applicable · Has a placebo group

Conditions studied: Peripheral Neuropathy, HIV, AIDS, HIV Infections

In brief

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.

Key facts

Study ID

NCT00826345

Run by

NYU Langone Health

People needed

20

Starts

2009-01-01

Expected to finish

2009-06-01

Last updated by the study team

2012-06-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Columbia University — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.