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Completed

NCT Number: NCT02598232

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

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.

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Key information

Conditions

Lumbar Herniated Intervertebral Disc Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1,414nm Nd:YAG Laser System

Device

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

Primary outcomes

  1. Change in the Oswestry Disability Index

    Time frame: Day 0, 24 weeks

Secondary outcomes

  1. Change in the Oswestry Disability Index

    Time frame: Day 0, 4 weeks, 12 weeks

  2. Change in the Visual Analogue Scale

    Time frame: Day 0, 4 weeks, 12 weeks, 24 weeks

  3. 12-Item Short-form Health Survey

    Time frame: Day 0, 4 weeks, 12 weeks, 24 weeks

  4. Evaluation of the pain level in 4 steps of excellent, good, fair, poor, according to MacNab's Criteria

    Time frame: Day 0, 4 weeks, 12 weeks, 24 weeks

Sponsors and collaborators

Lead sponsor

CynosureLutronic

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 5, 2015
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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