Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1,414nm Nd:YAG laser | Experimental | It has high absorption coefficient in water and a short pulse width. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1,414nm Nd:YAG Laser System | Device | It has high absorption coefficient in water and a short pulse width. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Oswestry Disability Index | Day 0, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Oswestry Disability Index | Day 0, 4 weeks, 12 weeks | |
| Change in the Visual Analogue Scale | Day 0, 4 weeks, 12 weeks, 24 weeks | |
| 12-Item Short-form Health Survey |
Not provided
Inclusion Criteria:
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Keung-nyun Kim, Professor | Severance Hospital | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 0, 4 weeks, 12 weeks, 24 weeks |
| Evaluation of the pain level in 4 steps of excellent, good, fair, poor, according to MacNab's Criteria | Day 0, 4 weeks, 12 weeks, 24 weeks |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |