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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02598232
Recruitment Status : Completed
First Posted : November 5, 2015
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
LUTRONIC Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lumbar Herniated Intervertebral Disc Device: 1,414nm Nd:YAG Laser System Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in the Oswestry Disability Index [ Time Frame: Day 0, 24 weeks ]

Secondary Outcome Measures :
  1. Change in the Oswestry Disability Index [ Time Frame: Day 0, 4 weeks, 12 weeks ]
  2. Change in the Visual Analogue Scale [ Time Frame: Day 0, 4 weeks, 12 weeks, 24 weeks ]
  3. 12-Item Short-form Health Survey [ Time Frame: Day 0, 4 weeks, 12 weeks, 24 weeks ]
  4. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02598232


Sponsors and Collaborators
LUTRONIC Corporation
Investigators
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Principal Investigator: Keung-nyun Kim, Professor Severance Hospital
More Information
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Responsible Party: LUTRONIC Corporation
ClinicalTrials.gov Identifier: NCT02598232    
Other Study ID Numbers: LU-DL-14-001
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations