Clinical trial NCT03421951: Change in Pain and Quality of Life Following SCS for Chronic Pain
Official title: 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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pain, Chronic
Pain, Radiating
Pain, Back
Pain Syndrome
Keywords: spine
lower limb
Lead sponsor: KM Clinical Research Group
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will be patients who have already been prescribed a trial spinal cord stimulator implant procedure to treat their lower back or lower limb pain.

Brief summary: 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.

Detailed description: 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 Investigators 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.

Eligibility criteria: 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:

Unwilling to sign Informed Consent and comply with protocol

Primary outcomes:
measure: Change in Pain Levels
timeFrame: 12 months post-permanent spinal cord stimulator implantation
measure: Change in quality of life
timeFrame: 12 months post-permanent spinal cord stimulator implantation
Secondary outcomes:
measure: Change in prescription pain medication use
timeFrame: 12 months post-permanent spinal cord stimulator implantation
Other outcomes:
Locations:
city: Murrieta
country: United States
facility: KM Clinical Research Group
state: California
Study officials:
affiliation: KM Clinical Research Group
name: Kate McLellan, PhD
role: STUDY_DIRECTOR
References: