An observational study in Spine Injuries and Disorders, Pain, Chronic and Pain, Back, sponsored by KM Clinical Research Group. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-04-26.
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 184th largest by enrollment of the 189 observational ones, is one of 78 that started in 2022, is one of 189 observational ones, and was the 647th registered.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
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. 78 started in 2022.
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:
The primary objective is changes in spine and lower limb pain following a laser-assisted neural decompression (LAND) procedure for the treatment of lumbar, thoracic, or cervical spine and/or extremity pain. Secondary objectives will be changes in quality of life, prescription pain medication use, and patient satisfaction with procedure outcomes.
Objectives The primary objective is changes in spine and lower limb pain following a laser-assisted neural decompression (LAND) procedure for the treatment of lumbar, thoracic, or cervical spine and/or extremity pain. Secondary objectives will be changes in quality of life, prescription pain medication use, and patient satisfaction with procedure outcomes.
Design and Outcomes This is a prospective observational study to determine the degree to which a laser-assisted neural decompression (LAND) procedure relieves spine and extremity pain. Subjects will have elected to have the procedure are part of their standard of care in treating their spine and/or leg pain. Subjects will complete a baseline survey and two follow-up surveys at 3-months and 12-months after their procedure date.
Interventions and Duration There will be no study intervention. Subjects will only be monitored and evaluated for pre- and post-operative pain, quality of life, satisfaction, and medication use. Subjects will be followed for 12 months following their LAND procedure.
Sample Size and Population This study will last for 4 years starting February 10, 2020. There will be no maximum subject population size. We aim for a minimum population size of 1,500 in order to give statistical significance with results.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
Browse Chronic Pain studies →KM Clinical Research Group is the lead sponsor of 3 studies on the registry; none are open to participants now.
Compared within Chronic Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients with a history of chronic spine and/or extremity pain that have tried at least 6 weeks of conservative care.
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.
Exclusion Criteria:
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.
The LAND procedure is a minimally invasive spinal decompression procedure that uses a focused laser beam to reduce and remove disc herniations that are causing nerve compressions and impingements within the spinal canal. It is performed in an outpatient setting and the patient receives local anesthesia. The LAND procedure has been performed extensively over the past 2-years on hundreds of patients, so including patients that have previously had the surgery allows for additional data points and improved reporting.
Also known as: LAND
Pain assessed with visual analogue scale
Change in pain levels as measured by a visual analogue scale
Time frame: 12-months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2022; primary completion for Mar 2023, 10 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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KM Clinical Research Group