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

Pain, Chronic Clinical Trial

— BURST  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03421951
• Other study ID #: 2017-PN-02
• Status: Terminated
• Start date: November 1, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: March 2020
• Source: KM Clinical Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: February 1, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Pain
• Pain Syndrome
• Pain, Back
• Pain, Chronic
• Pain, Radiating

Locations

Country	Name	City	State
United States	KM Clinical Research Group	Murrieta	California

Sponsors (1)

Lead Sponsor	Collaborator
KM Clinical Research Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Levels	Change in self-reported pain levels	12 months post-permanent spinal cord stimulator implantation
Primary	Change in quality of life	change in self-reported quality of life	12 months post-permanent spinal cord stimulator implantation
Secondary	Change in prescription pain medication use	change in opioid medication use to control pain	12 months post-permanent spinal cord stimulator implantation