Clinical trial NCT02598232: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Lumbar Herniated Intervertebral Disc
Lead sponsor: LUTRONIC Corporation
Sponsor class: INDUSTRY
First posted: 2015-11-05
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in the Oswestry Disability Index
timeFrame: Day 0, 24 weeks
Secondary outcomes:
measure: Change in the Oswestry Disability Index
timeFrame: Day 0, 4 weeks, 12 weeks
measure: Change in the Visual Analogue Scale
timeFrame: Day 0, 4 weeks, 12 weeks, 24 weeks
measure: 12-Item Short-form Health Survey
timeFrame: Day 0, 4 weeks, 12 weeks, 24 weeks
measure: Evaluation of the pain level in 4 steps of excellent, good, fair, poor, according to MacNab's Criteria
timeFrame: Day 0, 4 weeks, 12 weeks, 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Severance Hospital
name: Keung-nyun Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References: