Real-Time Accurate Pathology Inspection and Decompression Study

Withdrawn

• Conditions: Pain, Neck; Radiculopathy; Spine Injuries and Disorders; Pain, Back; Pain, Chronic

• Registration Number: NCT05347108
• Lead Sponsor: KM Clinical Research Group

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.

Study Timeline

• Study First Submitted: 2020-03-17
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-20
• Last Update Submitted: 2022-04-20
• Study First Posted: 2022-04-26
• Last Update Posted: 2022-04-26
• Study Start: 2022-05-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain assessed with visual analogue scale	12-months	Change in pain levels as measured by a visual analogue scale

Trial Locations

Locations (1)

KMCRG; 🇺🇸 Lā'ie, Hawaii, United States