Chronic Pain After Amputation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-08-31

Brief Summary

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This trial will test the effectiveness of amitriptyline in relieving chronic pain of adults that have had an amputation

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Detailed Description

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This double-masked placebo controlled trial will randomize patients (n=125) who are 6 months or more after amputation and have a 3 or more month history of pain to a daily dose of amitriptyline or a placebo for 6 weeks. Patients will receive a complete functional neurological examination by one of the study physicians or nurses masked to their treatment assignment. Study participants will also be interviewed by telephone to assess pain, pain interference with activities, physical and mental health, and number of health care visits for pain, at the beginning and end of the six-week trial and four months later.

Conditions

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Amputation, Traumatic Pain Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Amitriptyline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Amputation six months ago or longer
* Pain for 3 months or longer

Exclusion Criteria

* History of cardiovascular disease, seizures, or glaucoma
* Currently taking antidepressant medications
* Currently hyperthyroid or taking thyroid medication
* Currently pregnant

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No