Real-Time Accurate Pathology Inspection and Decompression Study

Pain, Chronic Clinical Trial

— RAPID  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05347108
• Other study ID #: CMC-01-2020
• Status: Withdrawn
• Start date: May 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: April 2022
• Source: KM Clinical Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Neck Pain
• Pain, Back
• Pain, Chronic
• Pain, Neck
• Radiculopathy
• Spine Injuries and Disorders

Intervention

Procedure:
• laser-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.

Locations

Country	Name	City	State
United States	KMCRG	La'ie	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
KM Clinical Research Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessed with visual analogue scale	Change in pain levels as measured by a visual analogue scale	12-months