Extremity Injury Clinical Trial
Official title:
Investigator Initiated Trial- Management of Chronic Pain in Military Patients With Injuries Sustained During Active Duty. Comparison of Spinal Cord Stimulation and Comprehensive Medical Management
The purpose of this study is to determine the degree to which spinal cord stimulation added to comprehensive medical management can provide increased relief of chronic pain in patients with injuries sustained while on active military duty, measured by patient assessments of pain.
The study population includes combat-injured patients and other patients injured while on active duty who experience chronic pain as a result of the injury and who receive treatment as active duty military personnel at Department of Defense facilities or through the Department of Veteran's Affairs. The population will include patients with pain related to limb amputation, and patients eligible for care in the Veteran's Administration Polytrauma Network program (Polytrauma Veterans) or for management of similar injuries within the Department of Defense health care system. Study subjects will have complex problems that are difficult to treat with current standard rehabilitative approaches. The circumstances of these patients' injuries create a substantial societal interest in determining and providing the best achievable rehabilitation, an interest that combines the expectation that medical science will advance the quality of medical care, practical benefits to subjects and society of returning patients to active duty or employment, and the moral imperative to support persons injured while defending our national security. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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