Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006448
Status:
COMPLETED
Last Update Posted:
2016-09-26
First Post:
2000-11-04
Brief Title:
Treatment of Chronic Pain After Spinal Cord Injury SCI or Amputation
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Spinal Cord Injury SCI and Amputation Pain Prevention and Treatment
Status:
COMPLETED
Status Verified Date:
2003-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 07 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5P01HD033989-05 | NIH | None | httpsreporternihgovquickSearch5P01HD033989-05 |