Status:
COMPLETED
Acupuncture/Moxibustion for Peripheral Neuropathy in HIV
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Peripheral Neuropathies
HIV Infections
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 5...
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, s...
Eligibility Criteria
Inclusion
- Men and women who are HIV positive or Centers for Disease Control (CDC)-defined AIDS diagnosed subjects who are 18 years of age or older, and have a history of distal symmetrical peripheral neuropathy of the lower extremities (legs and feet) for two months or greater.
- Patients experiencing moderate pain severity.
- Verification from primary provider of subject's: HIV status, diagnosis of DSP, and agreement that patient is clinically suitable for the study.
- Individuals able to successfully complete a mini-mental status exam.
- Individuals who understand and agree to complete daily symptom diaries for the duration of the study.
- Individuals taking antiretroviral combinations must have completed an initial 8 weeks of a stable regime (same drug\[s\], dose, and frequency) prior to entry into the study.
- Individuals taking chronic pain medications must be on a stable regime (same drug, dose, and 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, and 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, B-12 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 isoniazid (INH), dapsone, or metronidazole within 8 weeks prior to enrollment.
- Severe heart disease, uncontrolled high blood pressure, lung disease, or renal failure.
- Pregnant women
- Individuals receiving acupuncture currently and less than 6 months prior to enrollment.
- Individuals with a history of receiving moxibustion.
- Individuals currently receiving other types of complementary therapies such as herbs, massage, reiki, etc.
- Individuals with plans for travel, lifestyle change, or other activity that would preclude attending all of the planned study sessions and/or recording daily diary information.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00317291
Start Date
November 1 2005
End Date
January 1 2009
Last Update
September 11 2019
Active Locations (1)
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1
Columbia University School of Nursing, Acupuncture Laboratory
New York, New York, United States, 10032