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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.
Age
13 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
November 1, 1994
Completion Date
May 1, 1997
Last Updated
November 3, 2021
260
ACTUAL participants
Amitriptyline hydrochloride
DRUG
Amitriptyline hydrochloride placebo
DRUG
Point acupuncture
PROCEDURE
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NCT04142047
NCT06694805
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07428330