To evaluate the separate and combined efficacy of a standardized acupuncture regimen and amitriptyline on the relief of pain due to peripheral neuropathy and on the quality of life of HIV-infected patients. Both amitriptyline, an antidepressant, and acupuncture, a Chinese medical approach that uses needles to relieve pain, have been used successfully to reduce pain in some people. It is not known how effectively these approaches relieve or reduce pain in patients with peripheral neuropathy secondary to HIV infection.
Both amitriptyline, an antidepressant, and acupuncture, a Chinese medical approach that uses needles to relieve pain, have been used successfully to reduce pain in some people. It is not known how effectively these approaches relieve or reduce pain in patients with peripheral neuropathy secondary to HIV infection. Patients are randomized to receive either standardized point acupuncture or alternate point acupuncture treatment twice weekly for the first 6 weeks, then once weekly for the next 8 weeks, plus either oral amitriptyline or placebo daily for the entire 14 weeks. Acupuncture points are located on the lower leg. Patients are evaluated at weeks 6 and 14 and are asked to keep a daily pain diary.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
260
75 mg oral tablet taken daily
Oral placebo tablet taken daily
Standardized or alternate acupuncture procedure
Community Consortium of San Francisco
San Francisco, California, United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, United States
Baltimore Trials
Baltimore, Maryland, United States
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, United States
North Jersey Community Research Initiative
Newark, New Jersey, United States
Partners Research
Albuquerque, New Mexico, United States
Clinical Directors Network of Region II
New York, New York, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States
...and 1 more locations
Change in intensity of pain as measured by the daily pain diary and the global pain relief rating
Time frame: At Weeks 6 and 14
Change in quality life
Time frame: Throughout study
Change in neurological status
Time frame: Throughout study
Permanent discontinuation of study treatment due to treatment failure
Time frame: Throughout study
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