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

Sponsor
KM Clinical Research Group (Industry)
Overall Status
Terminated
CT.gov ID
NCT03421951
Collaborator
(none)
26
1
15
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    26 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Nov 1, 2017
    Actual Primary Completion Date :
    Jan 31, 2019
    Actual Study Completion Date :
    Feb 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Change in Pain Levels [12 months post-permanent spinal cord stimulator implantation]

      Change in self-reported pain levels

    2. Change in quality of life [12 months post-permanent spinal cord stimulator implantation]

      change in self-reported quality of life

    Secondary Outcome Measures

    1. Change in prescription pain medication use [12 months post-permanent spinal cord stimulator implantation]

      change in opioid medication use to control pain

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 KM Clinical Research Group Murrieta California United States 92563

    Sponsors and Collaborators

    • KM Clinical Research Group

    Investigators

    • Study Director: Kate McLellan, PhD, KM Clinical Research Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kate McLellan, Principle Investigator, KM Clinical Research Group
    ClinicalTrials.gov Identifier:
    NCT03421951
    Other Study ID Numbers:
    • 2017-PN-02
    First Posted:
    Feb 5, 2018
    Last Update Posted:
    Mar 19, 2020
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kate McLellan, Principle Investigator, KM Clinical Research Group
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 19, 2020