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
2 other identifiers
interventional
260
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
Started Nov 1994
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1994
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 3, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 quality life
Throughout study
Change in neurological status
Throughout study
Permanent discontinuation of study treatment due to treatment failure
Throughout study
Study Arms (1)
1
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Antiretroviral therapy.
- Nonsystemic treatment of Kaposi's sarcoma.
- Maintenance with an existing regimen of analgesic medication or herbal treatment.
- Concurrent Treatment: Required:
- Acupuncture.
- Patients must have:
- HIV infection.
- Lower extremity peripheral neuropathy secondary to HIV infection.
- Pain for at least 2 weeks prior to study entry.
- Life expectancy of at least 6 months.
- NOTE:
- Co-enrollment in other experimental protocols is permitted as long as dual participation is allowed in those protocols.
- Prior Medication:
- +2 more criteria
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Known allergy to amitriptyline (not applicable for patients at sites using an acupuncture only study design).
- EKG indicating malignant arrhythmia or cardiac conduction disturbances (not applicable for patients at sites using an acupuncture only study design).
- Prison incarceration.
- Concurrent Medication:
- Excluded:
- Active treatment for an acute opportunistic infection or malignancy (nonsystemic treatment of Kaposi's sarcoma is permitted).
- Other tricyclic antidepressants.
- MAO inhibitors.
- Patients with the following prior conditions are excluded (not applicable for patients at sites using an acupuncture only study design):
- History of cardiac disease.
- History of seizure disorder.
- Prior Medication:
- Excluded within 2 weeks prior to study entry:
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Community Consortium of San Francisco
San Francisco, California, 94110, United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 80204, United States
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, 20422, United States
Baltimore Trials
Baltimore, Maryland, 21201, United States
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, 48201, United States
North Jersey Community Research Initiative
Newark, New Jersey, 07103, United States
Partners Research
Albuquerque, New Mexico, 87131, United States
Clinical Directors Network of Region II
New York, New York, 10011, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, 10037, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107, United States
Related Publications (2)
Chavez C. Prickly business. The finer points of acupuncture. Posit Aware. 1995 Jan-Feb:14-5.
PMID: 11362204BACKGROUNDShlay JC, Chaloner K, Max MB, Flaws B, Reichelderfer P, Wentworth D, Hillman S, Brizz B, Cohn DL. Acupuncture and amitriptyline for pain due to HIV-related peripheral neuropathy: a randomized controlled trial. Terry Beirn Community Programs for Clinical Research on AIDS. JAMA. 1998 Nov 11;280(18):1590-5. doi: 10.1001/jama.280.18.1590.
PMID: 9820261BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Shlay J
- STUDY CHAIR
Flaws B
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Start
November 1, 1994
Study Completion
May 1, 1997
Last Updated
November 3, 2021
Record last verified: 2021-10