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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

Primary Purpose

HIV Infections, Peripheral Nervous System Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Amitriptyline hydrochloride
Amitriptyline hydrochloride placebo
Point acupuncture
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Peripheral Nervous System Diseases, Amitriptyline, Pain, Acupuncture Therapy

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Community Consortium of San Francisco
  • Denver CPCRA / Denver Public Hlth
  • Veterans Administration Med Ctr / Regional AIDS Program
  • Baltimore Trials
  • Comprehensive AIDS Alliance of Detroit
  • North Jersey Community Research Initiative
  • Partners Research
  • Clinical Directors Network of Region II
  • Harlem AIDS Treatment Group / Harlem Hosp Ctr
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
  • Philadelphia FIGHT

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm 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.

Outcomes

Primary Outcome Measures

Change in intensity of pain as measured by the daily pain diary and the global pain relief rating
Change in quality life
Change in neurological status
Permanent discontinuation of study treatment due to treatment failure

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000817
Brief Title
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
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 1997 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Peripheral Nervous System Disease
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Peripheral Nervous System Diseases, Amitriptyline, Pain, Acupuncture Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Amitriptyline hydrochloride
Intervention Description
75 mg oral tablet taken daily
Intervention Type
Drug
Intervention Name(s)
Amitriptyline hydrochloride placebo
Intervention Description
Oral placebo tablet taken daily
Intervention Type
Procedure
Intervention Name(s)
Point acupuncture
Intervention Description
Standardized or alternate acupuncture procedure
Primary Outcome Measure Information:
Title
Change in intensity of pain as measured by the daily pain diary and the global pain relief rating
Time Frame
At Weeks 6 and 14
Title
Change in quality life
Time Frame
Throughout study
Title
Change in neurological status
Time Frame
Throughout study
Title
Permanent discontinuation of study treatment due to treatment failure
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shlay J
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Flaws B
Official's Role
Study Chair
Facility Information:
Facility Name
Community Consortium of San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Denver CPCRA / Denver Public Hlth
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Veterans Administration Med Ctr / Regional AIDS Program
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Baltimore Trials
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Comprehensive AIDS Alliance of Detroit
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
North Jersey Community Research Initiative
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Partners Research
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Clinical Directors Network of Region II
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Harlem AIDS Treatment Group / Harlem Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Portland Veterans Adm Med Ctr / Rsch & Education Grp
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Philadelphia FIGHT
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11362204
Citation
Chavez C. Prickly business. The finer points of acupuncture. Posit Aware. 1995 Jan-Feb:14-5.
Results Reference
background
PubMed Identifier
9820261
Citation
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.
Results Reference
background

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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

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