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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV Infections, Peripheral Nervous System Disease

Intervention / Treatment
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* Drug: Amitriptyline hydrochloride
* Drug: Amitriptyline hydrochloride placebo
* Procedure: Point acupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* 75 mg oral tablet taken daily<br>Drug: Amitriptyline hydrochloride placebo<br>* Oral placebo tablet taken daily<br>Procedure: Point acupuncture<br>* Standardized or alternate acupuncture procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Peripheral Nervous System Diseases, Amitriptyline, Pain, Acupuncture Therapy