HIV Infections Clinical Trial
Official title:
Acu/Moxa for Peripheral Neuropathy in Persons With HIV
Verified date | September 2009 |
Source | National Center for Complementary and Integrative Health (NCCIH) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 50 |
Est. completion date | January 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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 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, 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. |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University School of Nursing, Acupuncture Laboratory | New York | New York |
Lead Sponsor | Collaborator |
---|---|
National Center for Complementary and Integrative Health (NCCIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptom diary | |||
Primary | Gracely Pain Scale | |||
Secondary | Subjective Peripheral Neuropathy Scale | |||
Secondary | Clinical Global Impression Scale | |||
Secondary | Neurological Assessment Form |
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