NCT00006427CompletedPhase 4
Management of Chronic Pain in Rehabilitation Project II Management of Chronic Pain in Persons With Amputation
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)2 sites in 1 country125 target enrollmentStarted: August 1, 1996Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 125
- Locations
- 2
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Phase 4
Chronic Pain in Spinal Cord InjurySpinal Cord InjuriesPainNCT00006428Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)100
Active, not recruiting
Not Applicable
Acceptability and Efficacy of Pain Reprocessing Therapy in Racially/ Ethnically Diverse Adults With Chronic Back PainPain, ChronicBack PainNCT05820204Weill Medical College of Cornell University150
Completed
Phase 3
Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS)Bladder DiseasesInterstitial CystitisNCT00124306National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)271
Completed
Phase 1
Clinical Trial of Integrated Treatment for Pain and Opioid DependenceOpiate DependenceChronic PainNCT00634803Yale University90
Completed
Not Applicable
The PainSMART Research Program: Evaluating a Pain Education Strategy for Patients Seeking Primary Care PhysiotherapyPainPain AcutePain, ChronicSelf EfficacyIllness PerceptionsPhysical Activity LevelSickness AbsenceReferral and ConsultationWorryPatient-Centered CareCommunicationAnxietyNCT06187428Kajsa Johansson494