Change in Pain and Quality of Life Following SCS for Chronic Pain

Terminated

• Conditions: Pain, Back; Pain Syndrome; Pain, Chronic; Pain, Radiating

• Registration Number: NCT03421951
• Lead Sponsor: KM Clinical Research Group

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.

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2018-01-30
• Study First Submitted QC: 2018-01-30
• Study First Posted: 2018-02-05
• Primary Completion: 2019-01-31
• Study Completion: 2019-02-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in quality of life	12 months post-permanent spinal cord stimulator implantation	change in self-reported quality of life
Change in Pain Levels	12 months post-permanent spinal cord stimulator implantation	Change in self-reported pain levels

Secondary Outcome Measures

Name	Time	Method
Change in prescription pain medication use	12 months post-permanent spinal cord stimulator implantation	change in opioid medication use to control pain

Trial Locations

Locations (1)

KM Clinical Research Group; 🇺🇸 Murrieta, California, United States