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

NCT ID: NCT00000817

Last Updated: 2021-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-11-30
• Study Completion Date: 1997-05-31

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.

Conditions

HIV Infections; Peripheral Nervous System Disease

Keywords

Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Peripheral Nervous System Diseases; Amitriptyline; Pain; Acupuncture Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

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.

Group Type: EXPERIMENTAL

Amitriptyline hydrochloride

Intervention Type: DRUG

75 mg oral tablet taken daily

Amitriptyline hydrochloride placebo

Intervention Type: DRUG

Oral placebo tablet taken daily

Point acupuncture

Intervention Type: PROCEDURE

Standardized or alternate acupuncture procedure

Interventions

Amitriptyline hydrochloride

75 mg oral tablet taken daily

Intervention Type: DRUG

Amitriptyline hydrochloride placebo

Oral placebo tablet taken daily

Intervention Type: DRUG

Point acupuncture

Standardized or alternate acupuncture procedure

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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:

Allowed:

• Antiretroviral therapy.

Exclusion Criteria

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:

• MAO inhibitors.
• Tricyclic antidepressants.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shlay J

Role: STUDY_CHAIR

Flaws B

Role: STUDY_CHAIR

Locations

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

Philadelphia FIGHT

Philadelphia, Pennsylvania, United States

Countries

United States

References

Chavez C. Prickly business. The finer points of acupuncture. Posit Aware. 1995 Jan-Feb:14-5.

Reference Type: BACKGROUND

PMID: 11362204 (View on PubMed)

Shlay 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.

Reference Type: BACKGROUND

PMID: 9820261 (View on PubMed)

Other Identifiers

11572

Identifier Type: REGISTRY

Identifier Source: secondary_id

CPCRA 022

Identifier Type: -

Identifier Source: org_study_id