Chronic Low Back and Leg Pain
Conditions
Keywords
activity, spinal cord stimulation, pain
Brief summary
The purpose of this study is to characterize a patient's activity levels before and after spinal cord stimulation therapy.
Interventions
None listed
Sponsors
MedtronicNeuro
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed