Clinical trial NCT00826345: Acupuncture/Moxibustion (Acu/Moxa) for Distal Symmetric Peripheral Neuropathy (DSP) in HIV
Official title: Patient-Oriented TCM Intervention for DSP in HIV: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
HIV
AIDS
HIV Infections
Keywords: Peripheral Neuropathy
Neuropathy
HIV
AIDS
DSP
alternative therapies
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2009-01-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Symptom diary Gracely Pain Scale
timeFrame: Baseline, Weekly and Follow-up visits
Secondary outcomes:
measure: Subjective Peripheral Neuropathy Screen (SPNS) Clinical Global Impression Scale Neurological Assessment Form
timeFrame: Baseline, weekly and follow-up visits
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Joyce K Anastasi, PhD
role: PRINCIPAL_INVESTIGATOR
References: