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

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ClinicalTrials.gov Identifier: NCT00006448
Recruitment Status : Completed
First Posted : November 6, 2000
Last Update Posted : September 26, 2016
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Spinal Cord Injuries Amputation, Traumatic Pain Behavioral: cognitive therapy Procedure: Physical Therapy Drug: Methadone

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Spinal Cord Injury (SCI) and Amputation Pain Prevention and Treatment
Study Start Date : August 1996
Primary Completion Date : July 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006448

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)
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 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2000    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: March 2003

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Spinal cord injury
Pain management

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Amputation, Traumatic
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents