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

Lumbar Herniated Intervertebral Disc Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598232
• Other study ID #: LU-DL-14-001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 4, 2015
• Last updated: March 7, 2017
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: April 2016
• Source: LUTRONIC Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Intervertebral Disc Displacement
• Lumbar Herniated Intervertebral Disc

Intervention

Device:
• 1,414nm Nd:YAG Laser System
It has high absorption coefficient in water and a short pulse width.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LUTRONIC Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Oswestry Disability Index		Day 0, 24 weeks
Secondary	Change in the Oswestry Disability Index		Day 0, 4 weeks, 12 weeks
Secondary	Change in the Visual Analogue Scale		Day 0, 4 weeks, 12 weeks, 24 weeks
Secondary	12-Item Short-form Health Survey		Day 0, 4 weeks, 12 weeks, 24 weeks
Secondary	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