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

Pain Clinical Trial

Official title:

Spinal Cord Injury (SCI) and Amputation Pain Prevention and Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006448
• Other study ID #: NICHD-0108
• Secondary ID: 5P01HD033989-05
• Status: Completed
• Phase: N/A
• First received: November 4, 2000
• Last updated: September 23, 2016
• Start date: August 1996

Study information

• Verified date: March 2003
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. primary completion date: July 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amputation, Traumatic
• Pain
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• cognitive therapy

Procedure:
• Physical Therapy

Drug:
• Methadone

Locations

Country	Name	City	State
United States	University of Pittsburg Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

External Links

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