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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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	Phase
Spinal Cord Injuries; Amputation, Traumatic; Pain	Behavioral: cognitive therapy; Procedure: Physical Therapy; Drug: Methadone	Not Applicable

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

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Study Type :	Interventional (Clinical Trial)
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
Actual Primary Completion Date :	July 2001

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Additional Information:

Click here for more information about the National Institute of Child Health and Human Development (NICHD). 

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
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; 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