Acupuncture/Moxibustion for Peripheral Neuropathy in HIV
Condition: Peripheral Neuropathies; HIV Infections
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Acupuncture/Moxibustion; Sham acupuncture/Placebo moxibustion
Intervention type(s): Procedure; Other
Intervention description(s): Acupuncture/Moxibustion: 16 scheduled sessions; Sham acupuncture/Placebo moxibustion: 16 scheduled sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acupuncture; HIV; AIDS; Symptom management; Non-invasive; Complementary Therapies; Treatment Experienced