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

NCT02598232 | Completed Phase 2

• 1 other identifier: LU-DL-14-001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lumbar Herniated Intervertebral Disc

Outcome Measures

Primary Outcomes (1)

• Change in the Oswestry Disability Index

  Day 0, 24 weeks

Secondary Outcomes (4)

• 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

  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

Study Arms (1)

1,414nm Nd:YAG laser

EXPERIMENTAL

It has high absorption coefficient in water and a short pulse width.

Device: 1,414nm Nd:YAG Laser System

Interventions

1,414nm Nd:YAG Laser System DEVICE

It has high absorption coefficient in water and a short pulse width.

1,414nm Nd:YAG laser

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LUTRONIC Corporation: lead

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Keung-nyun Kim, Professor

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 5, 2015
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 9, 2017

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share