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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) logo

National Institute of Allergy and Infectious Diseases (NIAID)

Status

Completed

Conditions

HIV Infections
Peripheral Nervous System Disease

Treatments

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

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

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

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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