Amputation, Traumatic, Pain, Postoperative Pain
Conditions
Keywords
Amputation, Chronic Pain, Amitriptyline
Brief summary
This trial will test the effectiveness of amitriptyline in relieving chronic pain of adults that have had an amputation
Detailed 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.
Interventions
DRUGAmitriptyline
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed