War Wounded, a Comparison of Two Pain Management Approaches
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|ClinicalTrials.gov Identifier: NCT01620411|
Recruitment Status : Withdrawn (Site was never activated by sponsor)
First Posted : June 15, 2012
Last Update Posted : August 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Injuries Pain||Other: Comprehensive Medical Management Procedure: Spinal Cord Stimulator||Not Applicable|
This study aims to investigate the relative effectiveness of two different pain management plans for injuries sustained while active duty in the military. One arm of the study has subjects undergo standard comprehensive medical management, while the other adds the placement of a spinal cord stimulator, a common procedure for the alleviation of pain.
This site was never activated for the research by the sponsor.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Management of Chronic Pain in Military Patients With Injuries Sustained During Active Duty. Comparison of Spinal Cord Stimulation and Comprehensive Medical Management.|
|Estimated Study Start Date :||June 2012|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2017|
Experimental: Comprehensive Medical Management (CMM)
This arm will receive standard of care treatment for injuries sustained while on active duty. Non-Invasive.
Other: Comprehensive Medical Management
Standard of care for failed back surgery syndrome sustained while on active duty, primarily focused on physical therapy, medication including: opioid analgesics, muscle relaxants, non-opioid analgesics, etc.
Experimental: CMM + Spinal Cord Stimulator (SCS)
This arm will combine comprehensive medical management with placement of a spinal cord stimulator.
Procedure: Spinal Cord Stimulator
This arm combines comprehensive medical management (as above) with the trial and possible eventual permenant placement of a spinal cord stimulator, a common pain management procedure.
- Decreased Pain Ratings [ Time Frame: 3 years ]Pain rating using the Numeric Pain Rating Scale (NPRS) over time. The NPRS is assessing the patients pain on a 11-point rating scale from 0 - 10 with 0 being no pain at all and 10 being the worst imaginable pain. The test is self-reported and can also be administered by an interviewer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620411
|United States, California|
|VA Hospital San Diego|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Tobias Moeller-Bertram||UCSD|