Treatment of Chronic Pain After Spinal Cord Injury (SCI) or Amputation
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Spinal Cord Injuries Amputation, Traumatic Pain |
Behavioral: cognitive therapy Procedure: Physical Therapy Drug: Methadone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Spinal Cord Injury (SCI) and Amputation Pain Prevention and Treatment |
| Estimated Enrollment: | 400 |
| Study Start Date: | August 1996 |
| Estimated Study Completion Date: | July 2001 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00006448
| United States, Pennsylvania | |
| University of Pittsburg Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Thomas E. Rudy, Ph.D. | University of Pittsburgh |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006448 History of Changes |
| Other Study ID Numbers: | NICHD-0108, 5P01 HD33989-05 |
| Study First Received: | November 4, 2000 |
| Last Updated: | May 20, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
Spinal cord injury Amputation Pain management |
Additional relevant MeSH terms:
|
Amputation, Traumatic Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases |
Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on February 27, 2015