NCT03421951

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

January 30, 2018

Last Update Submit

March 17, 2020

Conditions

Pain, ChronicPain, RadiatingPain, BackPain Syndrome

Keywords

spinelower limb

Outcome Measures

Primary Outcomes (2)

  • Change in Pain Levels

    Change in self-reported pain levels

    12 months post-permanent spinal cord stimulator implantation

  • Change in quality of life

    change in self-reported quality of life

    12 months post-permanent spinal cord stimulator implantation

Secondary Outcomes (1)

  • Change in prescription pain medication use

    12 months post-permanent spinal cord stimulator implantation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Unwilling to sign Informed Consent and comply with protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KM Clinical Research Group

Murrieta, California, 92563, United States

Location

MeSH Terms

Conditions

Chronic PainPainBack PainSomatoform Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Kate McLellan, PhD

    KM Clinical Research Group

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 30, 2018

First Posted

February 5, 2018

Study Start

November 1, 2017

Primary Completion

January 31, 2019

Study Completion

February 1, 2019

Last Updated

March 19, 2020

Record last verified: 2020-03

Locations

US(1)