Pain, ChronicBURSTNCT03421951
Change in Pain and Quality of Life Following SCS for Chronic Pain
An observational study of Pain, Chronic and Pain, Radiating, run by KM Clinical Research Group at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain, Chronic, Pain, Radiating, Pain, Back
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 1 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Unwilling to sign Informed Consent and comply with protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
KM Clinical Research Group
Murrieta, California, 92563
About this study
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 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.
Read the 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.
- Conditions
- Pain, Chronic, Pain, Radiating, Pain, Back, Pain Syndrome
- Keywords
- spine, lower limb
- Medical subject headings
- Chronic Pain, Pain, Back Pain, Somatoform Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Levels
Change in self-reported pain levels
Measured: 12 months post-permanent spinal cord stimulator implantation
Change in quality of life
change in self-reported quality of life
Measured: 12 months post-permanent spinal cord stimulator implantation
Secondary outcomes (1)
Change in prescription pain medication use
change in opioid medication use to control pain
Measured: 12 months post-permanent spinal cord stimulator implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 Nov 2017
- Primary completion31 Jan 2019
- Study completion1 Feb 2019
Why it stopped: Sponsor withdrew funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- KM Clinical Research Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Kate McLellan, KM Clinical Research Group
- Investigators
- Kate McLellan, PhD, Study director, KM Clinical Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421951
- Sponsor's protocol ID
- 2017-PN-02
- Acronym
- BURST
- Status last verified
- Mar 2020
- First submitted
- 30 Jan 2018
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03421951
- Acronym / sponsor ID
- BURST / 2017-PN-02
- Conditions
- Pain, Chronic, Pain, Radiating, Pain, Back, Pain Syndrome
- Keywords
- spine, lower limb
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor withdrew funding
- Enrolment
- 26 participants (actual)
- Lead sponsor
- KM Clinical Research GroupIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Unwilling to sign Informed Consent and comply with protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Pain Levels
Time frame: 12 months post-permanent spinal cord stimulator implantation
Change in self-reported pain levels
Change in quality of life
Time frame: 12 months post-permanent spinal cord stimulator implantation
change in self-reported quality of life
1 secondary outcome
Change in prescription pain medication use
Time frame: 12 months post-permanent spinal cord stimulator implantation
Results and safety
The study was stopped early (reason given: Sponsor withdrew funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate McLellan, PhD study director
KM Clinical Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Chronic and Pain, Radiating, run by KM Clinical Research Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor withdrew funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Levels (time frame: 12 months post-permanent spinal cord stimulator implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.