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

Lutronic

Status and phase

Completed

Phase 3

Phase 2

Conditions

Lumbar Herniated Intervertebral Disc

Treatments

Device: 1,414nm Nd:YAG Laser System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02598232

LU-DL-14-001

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

19 to 79 years old

Volunteers

No 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