Spinal Cord Stimulation Research Study
Completed
- Conditions
- Chronic Low Back and Leg Pain
- Registration Number
- NCT00768872
- Lead Sponsor
- MedtronicNeuro
- Brief Summary
The purpose of this study is to characterize a patient's activity levels before and after spinal cord stimulation therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline in Physical Activity (total centi-Gs per 5.125 seconds) 4, 12, 24 weeks post implant Change from Baseline in Posture Parameters (minutes per 24 hours) 4, 12, 24 weeks post implant
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Napa Pain Institute
🇺🇸Napa, California, United States
Brigham and Women's Hospital
🇺🇸Chestnut Hill, Massachusetts, United States
Medical Advanced Pain Specialists (MAPS)
🇺🇸Edina, Minnesota, United States
Napa Pain Institute🇺🇸Napa, California, United States