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Chronic Pain After Amputation

United States Department of Health and Human Services (HHS) logo

United States Department of Health and Human Services (HHS)

Status and phase

Completed
Phase 4

Conditions

Postoperative Pain
Amputation, Traumatic
Pain

Treatments

Drug: Amitriptyline

Study type

Interventional

Funder types

NIH

Identifiers

NCT00006427
NICHD-0121
P01HD033988 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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