This trial is active, not recruiting.

Condition lumbar herniated intervertebral disc
Treatment 1,414nm nd:yag laser system
Phase phase 3
Sponsor LUTRONIC Corporation
Start date October 2014
End date October 2015
Trial size 30 participants
Trial identifier NCT02598232, LU-DL-14-001


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
1,414nm Nd:YAG Laser Treatment after Percutaneous Epidural Neuroplasty(PEN)
1,414nm nd:yag laser system
The intervention is an ACCUPLASTI which is an 1,414 nm Nd:YAG interstitial fiber laser.

Primary Outcomes

Change in the Oswestry Disability Index
time frame: Day 0, 24 weeks

Secondary Outcomes

Change in the Oswestry Disability Index
time frame: Day 0, 4 weeks, 12 weeks
Change in the Visual Analogue Scale
time frame: Day 0, 4 weeks, 12 weeks, 24 weeks
12-Item Short-form Health Survey
time frame: Day 0, 4 weeks, 12 weeks, 24 weeks
MacNab's Criteria
time frame: Day 0, 4 weeks, 12 weeks, 24 weeks

Eligibility Criteria

Male or female participants from 19 years up to 79 years old.

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

Additional Information

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
Principal investigator Keung-nyun Kim, Professor
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by LUTRONIC Corporation.