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

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

Conditions: HIV Infections; Peripheral Nervous System Disease

Treatments: Procedure: Point acupuncture; Drug: Amitriptyline hydrochloride; Drug: Amitriptyline hydrochloride placebo

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000817

CPCRA 022

11572 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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260 participants in 1 patient group

1

Experimental group

Description:

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.

Treatment:

Drug: Amitriptyline hydrochloride

Drug: Amitriptyline hydrochloride placebo

Procedure: Point acupuncture