search
Back to results

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

Primary Purpose

Lumbar Herniated Intervertebral Disc

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
1,414nm Nd:YAG Laser System
Sponsored by
LUTRONIC Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Herniated Intervertebral Disc

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1,414nm Nd:YAG laser

    Arm Description

    It has high absorption coefficient in water and a short pulse width.

    Outcomes

    Primary Outcome Measures

    Change in the Oswestry Disability Index

    Secondary Outcome Measures

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

    Full Information

    First Posted
    November 4, 2015
    Last Updated
    March 7, 2017
    Sponsor
    LUTRONIC Corporation
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02598232
    Brief Title
    The Efficacy and Safety of the 1,414 nm Nd:YAG Laser System for Alleviating Back Pain in a Lumbar Disc Patient
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    LUTRONIC Corporation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbar Herniated Intervertebral Disc

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1,414nm Nd:YAG laser
    Arm Type
    Experimental
    Arm Description
    It has high absorption coefficient in water and a short pulse width.
    Intervention Type
    Device
    Intervention Name(s)
    1,414nm Nd:YAG Laser System
    Intervention Description
    It has high absorption coefficient in water and a short pulse width.
    Primary Outcome Measure Information:
    Title
    Change in the Oswestry Disability Index
    Time Frame
    Day 0, 24 weeks
    Secondary Outcome Measure Information:
    Title
    Change in the Oswestry Disability Index
    Time Frame
    Day 0, 4 weeks, 12 weeks
    Title
    Change in the Visual Analogue Scale
    Time Frame
    Day 0, 4 weeks, 12 weeks, 24 weeks
    Title
    12-Item Short-form Health Survey
    Time Frame
    Day 0, 4 weeks, 12 weeks, 24 weeks
    Title
    Evaluation of the pain level in 4 steps of excellent, good, fair, poor, according to MacNab's Criteria
    Time Frame
    Day 0, 4 weeks, 12 weeks, 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Keung-nyun Kim, Professor
    Organizational Affiliation
    Severance Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs