Treatment of Chronic Pain After Spinal Cord Injury (SCI) or Amputation

Not Applicable

Completed

• Conditions: Spinal Cord Injuries; Amputation, Traumatic; Pain

• Registration Number: NCT00006448
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary

Pain is a major problem for people after spinal cord injuries and amputations. This is a study to test how pain is affected by adding methadone to a six-week program of weekly physical therapy, relaxation training and counseling. Individuals who qualify for this study will receive a comprehensive medical and physical therapy evaluation.

Detailed Description

Pain has a major impact on the functioning of individuals with spinal cord injuries and individuals with amputations. This double-masked randomized trial to evaluate the utility of a combination of psychological intervention and physical therapy in order to improve pain reduction, increase physical functioning and quality of life for patients with pain associated with spinal cord injuries or amputations will compare the effect of a 6 week program of physical therapy and cognitive-behavioral therapy with methadone to one without methadone (n = 400). Secondary outcomes are to evaluate the maintenance of effects of the combined intervention and to evaluate the usefulness of a course of opioid therapy compared to active placebo medication. Based on the sample size, all measures have greater than 0.7 power to detect major within group differences at posttreatment, 6-month follow-up, and 12-month follow-up (taking into account a 15% attrition rate, alpha .05). Patients who qualify for this study will receive a comprehensive medical and physical therapy evaluation at baseline. Outcome will be assessed by the physician, psychiatrist and physical therapist who are all masked both to the treatment condition and therapy. Pain is assessed through self-report (measures include pain inventories) and clinical interview.

Study Timeline

• Study Start: 1996-08
• Study First Submitted: 2000-11-04
• Study First Submitted QC: 2000-11-04
• Study First Posted: 2000-11-06
• Primary Completion: 2001-07
• Status Verified: 2003-03
• Last Update Submitted: 2016-09-23
• Last Update Posted: 2016-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Individuals with spinal cord injury or amputation, who have persistent pain of three months or longer duration.

Exclusion Criteria

• Pregnant women
• Allergy to latex, methadone, or diphenhydramine
• Surgery planned
• History of substance abuse in past two years
• History of major psychiatric disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

University of Pittsburg Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States