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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Peripheral Nervous System Disease
• Intervention / Treatment: Drug: Amitriptyline hydrochloride; Drug: Amitriptyline hydrochloride placebo; Procedure: Point acupuncture

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.

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Community Consortium of San Francisco
  • Colorado
    • Denver, Colorado, United States, 80204
      • Denver CPCRA / Denver Public Hlth
  • District of Columbia
    • Washington, District of Columbia, United States, 20422
      • Veterans Administration Med Ctr / Regional AIDS Program
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Baltimore Trials
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Comprehensive AIDS Alliance of Detroit
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • North Jersey Community Research Initiative
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • Partners Research
  • New York
    • New York, New York, United States, 10011
      • Clinical Directors Network of Region II
    • New York, New York, United States, 10037
      • Harlem AIDS Treatment Group / Harlem Hosp Ctr
  • Oregon
    • Portland, Oregon, United States, 97210
      • Portland Veterans Adm Med Ctr / Rsch & Education Grp
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Philadelphia FIGHT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Amitriptyline hydrochloride; 75 mg oral tablet taken daily; Drug: Amitriptyline hydrochloride placebo; Oral placebo tablet taken daily; Procedure: Point acupuncture; Standardized or alternate acupuncture procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Chair: Shlay J; Study Chair: Flaws B

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: November 1, 1994
• Study Completion (Actual): May 1, 1997

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Amitriptyline; Acupuncture Therapy; Peripheral Nervous System Diseases
• Additional Relevant MeSH Terms: Neuromuscular Diseases; Peripheral Nervous System Diseases; Nervous System Diseases; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Tricyclic; Adrenergic Uptake Inhibitors; Amitriptyline
• Other Study ID Numbers: CPCRA 022; 11572 (Registry Identifier: DAIDS ES Registry Number)