Pain, Back, Pain, Chronic, Pain, Neck, Radiculopathy, Spine Injuries and Disorders
Conditions
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.
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.
Interventions
PROCEDURElaser-assisted neural decompression (LAND) procedure
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.
Sponsors
KM Clinical Research Group
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Prescribed spinal decompression procedure 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
* Inability or unwillingness to give written informed consent. * Not a candidate for the LAND procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessed with visual analogue scale | 12-months | Change in pain levels as measured by a visual analogue scale |
Countries
United States
Outcome results
None listed