RAPID: Real-Time Accurate Pathology Inspection and Decompression Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Pain assessed with visual analogue scale [12-months]
Change in pain levels as measured by a visual analogue scale
Eligibility Criteria
Criteria
Inclusion Criteria:
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Prescribed spinal decompression procedure by their healthcare provider.
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Previous conservative care such as physical therapy or chiropractic care that failed to provide adequate pain relief.
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Willing and able to adhere to the protocol of the study including the survey timeline.
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Between the ages of 18-85 years.
Exclusion Criteria:
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Inability or unwillingness to give written informed consent.
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Not a candidate for the LAND procedure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | KMCRG | Lā'ie | Hawaii | United States | 96762 |
Sponsors and Collaborators
- KM Clinical Research Group
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CMC-01-2020