Clinical trial NCT05347108: Real-Time Accurate Pathology Inspection and Decompression Study
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Spine Injuries and Disorders
Pain, Chronic
Pain, Back
Pain, Neck
Radiculopathy
Lead sponsor: KM Clinical Research Group
Sponsor class: INDUSTRY
First posted: 2022-04-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain assessed with visual analogue scale
timeFrame: 12-months
Secondary outcomes:
Other outcomes:
Locations:
city: Lā'ie
country: United States
facility: KMCRG
state: Hawaii
Study officials:
References: