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Treatment of Chronic Pain after Spinal Cord Injury (SCI) or Amputation Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Treatment of Chronic Pain after Spinal Cord Injury (SCI) or Amputation conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Treatment of Chronic Pain after Spinal Cord Injury (SCI) or Amputation Clinical research trials and Treatment of Chronic Pain after Spinal Cord Injury (SCI) or Amputation healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Treatment of Chronic Pain after Spinal Cord Injury (SCI) or Amputation. Treatment of Chronic Pain after Spinal Cord Injury (SCI) or Amputation Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Treatment of Chronic Pain after Spinal Cord Injury (SCI) or Amputation clinical trial. Human subjects often receive the most effective healthcare possible for their Treatment of Chronic Pain after Spinal Cord Injury (SCI) or Amputation condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Treatment of Chronic Pain after Spinal Cord Injury (SCI) or Amputation  Treatment of Chronic Pain after Spinal Cord Injury (SCI) or Amputation
Treatment of Chronic Pain after Spinal Cord Injury (SCI) or Amputation
For Condition: Spinal Cord Injuries,Amputation, Traumatic,Pain
Status: No longer recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 400
Location and Contact Information:
Overall Study Official:
ThomasRudy, Principal Investigator, University of Pittsburgh Medical Center
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, 15213
United States
Additional Information:
Study ID Numbers: NICHD-0108; 5P01 HD33989-05
Study Start Date: August 1996
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006448
Other Pain Studies:
1. Treatment of Chronic Pain after Spinal Cord Injury (SCI) or Amputation
Related Studies:
Other Pain Clinical Trials
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Treatment of Chronic Pain after Spinal Cord Injury (SCI) or Amputation
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