Acupuncture/Moxibustion for Peripheral Neuropathy in HIV
NCT00317291 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2019-09-11
Summary
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).
Conditions
- Peripheral Neuropathies
- HIV Infections
Interventions
- PROCEDURE
-
Acupuncture/Moxibustion
Acupuncture/Moxibustion: 16 scheduled sessions
- OTHER
-
Sham acupuncture/Placebo moxibustion
Sham acupuncture/Placebo moxibustion: 16 scheduled sessions
Sponsors & Collaborators
-
National Center for Complementary and Integrative Health (NCCIH)
lead NIH
Principal Investigators
-
Joyce K Anastasi, PhD, DrNP · Columbia University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-11-30
- Primary Completion
- 2009-01-31
- Completion
- 2009-01-31
Countries
- United States
Study Locations
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