The Efficacy of a Standardized Acupuncture Regimen and Amitriptyline Compared With Placebo as a Treatment for Pain Caused by Peripheral Neuropathy in HIV-Infected Patients

Not Applicable

Completed

Interventions: Drug: Amitriptyline hydrochloride
Drug: Amitriptyline hydrochloride placebo
Procedure: Point acupuncture

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
1	Amitriptyline hydrochloride	Participants will receive standardized 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.
1	Amitriptyline hydrochloride placebo	Participants will receive standardized 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.
1	Point acupuncture	Participants will receive standardized 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.

Primary Outcome Measures

Name	Time	Method
Change in quality life	Throughout study
Change in intensity of pain as measured by the daily pain diary and the global pain relief rating	At Weeks 6 and 14
Change in neurological status	Throughout study
Permanent discontinuation of study treatment due to treatment failure	Throughout study

Secondary Outcome Measures

Name	Time	Method

Locations (11): Harlem AIDS Treatment Group / Harlem Hosp Ctr
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New York, New York, United States
Partners Research
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Albuquerque, New Mexico, United States
Clinical Directors Network of Region II
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New York, New York, United States
Comprehensive AIDS Alliance of Detroit
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Detroit, Michigan, United States
Denver CPCRA / Denver Public Hlth
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Denver, Colorado, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
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Portland, Oregon, United States
Veterans Administration Med Ctr / Regional AIDS Program
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Washington, District of Columbia, United States
Community Consortium of San Francisco
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San Francisco, California, United States
North Jersey Community Research Initiative
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Newark, New Jersey, United States
Philadelphia FIGHT
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Philadelphia, Pennsylvania, United States
Baltimore Trials
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Baltimore, Maryland, United States