Status:
COMPLETED
Acupuncture/Moxibustion (Acu/Moxa) for Distal Symmetric Peripheral Neuropathy (DSP) in HIV
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Columbia University
Conditions:
Peripheral Neuropathy
HIV
Eligibility:
All Genders
18-70 years
Phase:
NA
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 (TC...
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 Mo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00826345
Start Date
January 1 2009
End Date
June 1 2009
Last Update
June 22 2012
Active Locations (1)
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1
Columbia University
New York, New York, United States, 10032