An observational study in Pain, Chronic, Pain, Radiating and Pain, Back, sponsored by KM Clinical Research Group. Terminated at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-03-19.
Sponsored by KM Clinical Research Group · Observational
Among 1,283 studies in Chronic Pain with a site in United States — 259 open to participants now, 350 under way, 8 of them phase 3. Chronic Pain · United States.
Among the 1,283 studies in Chronic Pain with a site in United States, this one is the 158th largest by enrollment of the 189 observational ones, is one of 63 that started in 2017, is one of 189 observational ones, and was the 435th registered.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's enrollment of 26 is below the median of 120 across 753 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →259 of the 1,283 studies in Chronic Pain with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →1,283 studies; the count open now beside each. This study's row is marked.
First in 1992; this study’s year is marked. 63 started in 2017.
Median enrollment 60 across the 1,092 interventional studies, 100 across the 189 observational. Of the 847 that completed or were terminated, 386 (46%) have results posted.
209 of 1,283 have an industry lead sponsor. The 10 most frequent:
KM Clinical Research Group is the lead sponsor of 3 studies on the registry; none are open to participants now.
KM Clinical Research Group has 2 studies filed under Chronic Pain — fewer than ten, so there is no comparison to draw.
141 of the studies in Chronic Pain with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05703178Phase 3Northwestern UniversityWeb-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia | 2026-11-30 |
| NCT06091202Phase 3Oregon Health and Science UniversityTele-Collaborative Outreach to Rural Patients With Chronic Pain | 2027-05-01 |
| NCT05459402Phase 3University of Maryland, BaltimoreDivided or Single Exposure (DOSE) Study | 2027-06-01 |
| NCT02979574Memorial Sloan Kettering Cancer CenterPEACE: Comparing Chronic Pain Treatment Options | 2026-11 |
| NCT03984565Staci Gruber, Ph.D.PAIN: A Project Assessing the Impact of a Novel Cannabinoid Product | 2026-11 |
Among the 1,283 studies in Chronic Pain with a site in United States, from their registry updates:
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.
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 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 and comply with protocol
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Change in Pain Levels
Change in self-reported pain levels
Time frame: 12 months post-permanent spinal cord stimulator implantation
Change in quality of life
change in self-reported quality of life
Time frame: 12 months post-permanent spinal cord stimulator implantation
Change in prescription pain medication use
change in opioid medication use to control pain
Time frame: 12 months post-permanent spinal cord stimulator implantation
Ran from Nov 2017 to primary completion in Jan 2019, 14 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
KM Clinical Research Group