Status:
COMPLETED
Spinal Cord Stimulation Research Study
Lead Sponsor:
MedtronicNeuro
Conditions:
Chronic Low Back and Leg Pain
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to characterize a patient's activity levels before and after spinal cord stimulation therapy.
Eligibility Criteria
Inclusion
- 18 years of age or older
- Candidate for SCS device trial
- Subject is ambulatory
- Diagnosed with low back pain or low back pain plus leg pain for at least 6 months
- Undergoing treatment for low back pain or low back pain plus leg pain
- Does not have or has not had a previous SCS implant
- Willing and able to complete protocol requirements
- Willing and able to sign the study-specific Informed Consent form
- Male or non-pregnant female
Exclusion
- Have plans to enroll in another clinical study during their participation in this study, or are currently enrolled in a clinical study that could interfere in participation in the trial or affect the scientific soundness of this study
- Cancer or any other malignant disease
- Present or past diagnosis of schizophrenia or of delusional, psychotic, or dissociative disorder
- A pain-related surgery in the previous 12 weeks of enrollment, the intent to undergo surgery during the period of the study
- Non-English speaking or an inability to complete questionnaires accurately
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00768872
Start Date
October 1 2008
End Date
March 1 2013
Last Update
October 14 2016
Active Locations (3)
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1
Napa Pain Institute
Napa, California, United States, 94558
2
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467
3
Medical Advanced Pain Specialists (MAPS)
Edina, Minnesota, United States, 55435