Real-Time Accurate Pathology Inspection and Decompression Study (RAPID)

Real-Time Accurate Pathology Inspection and Decompression Study: A Prospective Observational Study on the Correlation Between Duration of Pain and Changes in Pain Levels Following of a Laser Decompression Procedure to Relieve Spine Pain

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.

Study Overview

• Status: Withdrawn
• Conditions: Radiculopathy; Pain, Chronic; Spine Injuries and Disorders; Pain, Back; Pain, Neck
• Intervention / Treatment: Procedure: laser-assisted neural decompression (LAND) procedure

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Lā'ie, Hawaii, United States, 96762
      • KMCRG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with a history of chronic spine and/or extremity pain that have tried at least 6 weeks of conservative care.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessed with visual analogue scale	Change in pain levels as measured by a visual analogue scale	12-months

Collaborators and Investigators

• Sponsor: KM Clinical Research Group

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Back Injuries; Back Pain; Chronic Pain; Neck Pain; Radiculopathy; Spinal Injuries
• Other Study ID Numbers: CMC-01-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No