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Treatment of Chronic Pain After Spinal Cord Injury (SCI) or Amputation
This study has been completed.
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00006448
First received: November 4, 2000
Last updated: September 23, 2016
Last verified: March 2003
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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 Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Spinal Cord Injury (SCI) and Amputation Pain Prevention and Treatment |
Resource links provided by NLM:
Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
| Estimated Enrollment: | 400 |
| Study Start Date: | August 1996 |
| Primary Completion Date: | July 2001 (Final data collection date for primary outcome measure) |
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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006448
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006448
Locations
| United States, Pennsylvania | |
| University of Pittsburg Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
| Principal Investigator: | Thomas E. Rudy, Ph.D. | University of Pittsburgh |
More Information
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00006448 History of Changes |
| Other Study ID Numbers: |
NICHD-0108 5P01HD033989-05 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | November 4, 2000 |
| Last Updated: | September 23, 2016 |
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:
|
Spinal Cord Injuries Wounds and Injuries Amputation, Traumatic Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Methadone Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antitussive Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on June 22, 2017