NCT00317291

Acupuncture/Moxibustion for Peripheral Neuropathy in HIV

Acu/Moxa for Peripheral Neuropathy in Persons With HIV

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: National Center for Complementary and Integrative Health (NCCIH) · NIH
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

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: 1. 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. 2. 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. 3. 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. 4. To evaluate the logistics of a CAM clinical trial on persons with HIV/AIDS experiencing DSP.

Conditions

• Peripheral Neuropathies
• HIV Infections

Interventions

Type	Name	Description
PROCEDURE	Acupuncture/Moxibustion	Acupuncture/Moxibustion: 16 scheduled sessions
OTHER	Sham acupuncture/Placebo moxibustion	Sham acupuncture/Placebo moxibustion: 16 scheduled sessions

Timeline

• Start date: 2005-11-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2006-04-24
• Last updated: 2019-09-11

Locations

1 site across 1 country: United States