Change in Pain and Quality of Life Following SCS for Chronic Pain
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Back Pain, Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 2/7/2018 |
| Start Date: | November 1, 2017 |
| End Date: | July 1, 2020 |
A Prospective Single-arm, Multi-center Clinical Study Examining the Changes in Quality of Life and Pain Following Dorsal Root Ganglion Stimulation for the Treatment of Chronic Intractable Pelvic and Lower Limb Pain
Study Title Subject-reported treatment efficacy and procedure satisfaction (steps)
study.BURST study- a prospective observational clinical study examining the changes in
quality of life and pain following spinal cord stimulation for the treatment of chronic
intractable lower back and lower limb pain.
study.BURST study- a prospective observational clinical study examining the changes in
quality of life and pain following spinal cord stimulation for the treatment of chronic
intractable lower back and lower limb pain.
Objectives The primary objective is changes in lower back and/or lower limb pain
patient-reported satisfaction with procedure outcome and treatment efficacy to reduce pain
levels following an orthopedic procedure for knees, hips, shoulders, elbows, wrists, or
anklesspinal cord (SCS) stimulation. Secondary objectives include changes in physical health,
quality of life, and quality of life and pain-related prescription medication usage.
Design and Outcomes This is a prospective observational single-arm study to access the
primary outcome variable of lower back and/or lower limb patient satisfaction with procedure
outcomes as measured using a modified MacNab scale. Patients will have presented to their
healthcare providers with knee, hip, shoulder, elbow, wrist, or ankle pain and will have
elected and been assigned a medically-appropriate surgical procedure as part of their
standard of care. It is possible for subjects to have multiple areas of pain and subsequent
surgeries, and subjects have the option of completing surveys for all
medically-indicatedmedically indicated areas being treated.pain
IIIntervention and Duration There will be no study intervention. Subjects will only be
monitored and evaluated for pre and post-operative satisfaction, pain, physical activity
levels, quality of life, and medication use levels. Subjects will be followed for 12 months
following their SCS stimulation implant procedure.
Sample Size and Population We aim for a minimum population size of 1,500 in order to give
statistical significance with results. Subjects will be stratified by surgical procedurearea
of chronic pain.
patient-reported satisfaction with procedure outcome and treatment efficacy to reduce pain
levels following an orthopedic procedure for knees, hips, shoulders, elbows, wrists, or
anklesspinal cord (SCS) stimulation. Secondary objectives include changes in physical health,
quality of life, and quality of life and pain-related prescription medication usage.
Design and Outcomes This is a prospective observational single-arm study to access the
primary outcome variable of lower back and/or lower limb patient satisfaction with procedure
outcomes as measured using a modified MacNab scale. Patients will have presented to their
healthcare providers with knee, hip, shoulder, elbow, wrist, or ankle pain and will have
elected and been assigned a medically-appropriate surgical procedure as part of their
standard of care. It is possible for subjects to have multiple areas of pain and subsequent
surgeries, and subjects have the option of completing surveys for all
medically-indicatedmedically indicated areas being treated.pain
IIIntervention and Duration There will be no study intervention. Subjects will only be
monitored and evaluated for pre and post-operative satisfaction, pain, physical activity
levels, quality of life, and medication use levels. Subjects will be followed for 12 months
following their SCS stimulation implant procedure.
Sample Size and Population We aim for a minimum population size of 1,500 in order to give
statistical significance with results. Subjects will be stratified by surgical procedurearea
of chronic pain.
Inclusion Criteria:
Prescribed spinal cord stimulator implant by their healthcare provider. Previous
conservative care such as physical therapy or chiropractic care that failed to provide
adequate pain relief.
Willing and able to adhere to the protocol of the study including the survey timeline.
Between the ages of 18-85 years.
Exclusion Criteria:
Inability or unwillingness to give written informed consent.
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