The Efficacy and Safety of the 1,414 nm Nd:YAG Laser System for Alleviating Back Pain in a Lumbar Disc Patient

A 24-week, Single-center, Open-label, Clinical Study to Evaluate the Efficacy and Safety of the 1,414nm Nd:YAG Laser System Added to PEN to Further Alleviate Back Pain in a Lumbar Herniated Intervertebral Disc Patient

This study aims to evaluate the efficacy and safety of the 1,414nm Nd:YAG laser system (ACCUPLASTI) added to Percutaneous Epidural Neuroplasty (PEN), a conventional treatment, to alleviate back pain in a lumbar herniated intervertebral disc patient.

Study Overview

• Status: Completed
• Conditions: Lumbar Herniated Intervertebral Disc
• Intervention / Treatment: Device: 1,414nm Nd:YAG Laser System

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients 19-79 years old
• Patients with moderate disability based on the Oswestry Disability Index (ODI), among those diagnosed with a single level of unilateral herniated intervertebral disc among the 3rd-4th and 4th-5th lumbar vertebrae, or the 5th lumbar vertebra-sacral vertebra with back pain or radiating pain in the lower extremities that has been unresponsive to conservative therapy for more than six weeks
• Patients who have language skills enough to answer questionnaires
• Patients who agree to voluntarily participate in this study and to sign the Informed Consent Form, and who are able to participate for the entire period of this study

Exclusion Criteria:

• Patients with a multi-level, far-lateral, or bilateral lumbar herniated intervertebral disc
• Patients who use an electronic medical device for their cardiovascular system
• Patients who have spondylolisthesis in the relevant lesion
• Patients with neurological defects
• Patients who had undergone surgery on the relevant lumbar vertebra
• Patients with cauda equina syndrome
• Patients with congenital spinal deformity
• Patients with spinal fracture
• Patients with spinal infection, tumor, or other form of inflammatory spondylopathy
• Patients with coagulation disorder
• Patients with a history of malignant tumor (except those with a cured tumor and no re- occurrence for the last five years)
• Patients who had participated in another clinical study within 30 days from their screening visit

• Female patients with child-bearing potential who do not agree to use a medically acceptable contraceptive method* for up to 24 weeks after the use of the investigational medical device during this study

  • Medically acceptable contraceptive method: Condom, oral contraceptive pills taken continuously for more than three months, contraceptive injection or implants, intra- uterine contraceptive device, etc.
• Patients who are pregnant or breastfeeding
• Other patients who are considered unfit to participate in this study with clinically significant findings based on the investigator's judgment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1,414nm Nd:YAG laser; It has high absorption coefficient in water and a short pulse width.	Device: 1,414nm Nd:YAG Laser System; It has high absorption coefficient in water and a short pulse width.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the Oswestry Disability Index	Day 0, 24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in the Oswestry Disability Index	Day 0, 4 weeks, 12 weeks
Change in the Visual Analogue Scale	Day 0, 4 weeks, 12 weeks, 24 weeks
12-Item Short-form Health Survey	Day 0, 4 weeks, 12 weeks, 24 weeks
Evaluation of the pain level in 4 steps of excellent, good, fair, poor, according to MacNab's Criteria	Day 0, 4 weeks, 12 weeks, 24 weeks

Collaborators and Investigators

• Sponsor: LUTRONIC Corporation
• Investigators: Principal Investigator: Keung-nyun Kim, Professor, Severance Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: November 4, 2015
• First Submitted That Met QC Criteria: November 4, 2015
• First Posted (Estimate): November 5, 2015

Study Record Updates

• Last Update Posted (Actual): March 9, 2017
• Last Update Submitted That Met QC Criteria: March 7, 2017
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Back Pain; Intervertebral Disc Displacement
• Other Study ID Numbers: LU-DL-14-001

Plan for Individual participant data (IPD)

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