The Effects of MLS LASER Therapy in Patients With Chronic Nonspecific Neck Pain

May 19, 2023 updated by: Lisa Berti, Istituto Ortopedico Rizzoli

Pilot Study on the Effects of MLS (Multiwave Locked System) LASER Therapy in Patients With Chronic Nonspecific Neck Pain: Randomized Controlled Trial Versus Placebo

Non-specific cronic low back pain is very common condition affecting 30-50% of adults. It is featured by neck muscles contractures which lead to pain and reduction of cervical spine mobility. High intensity laser therapy has been shown to be an effective treatment to improve symothoms in patient with non-specific neck pain.

The aim of this study is to assess the effects of a multi-wave locked system laser therapy in patient with non-specif neck pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • IRCCS Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Chronic low back pain (> 3 months)
  • Body mass index < 30
  • Preserved cognitive ability to fully understand and observe indications received by medical personnel
  • Ability to understand and give an informed consent

Exclusion Criteria:

  • Spine surgery
  • Spinal hernia
  • spondylolisthesis
  • Spinal infections
  • Severe spine deformities
  • Neural diseases
  • Upper limbs radiculopathy
  • Cervical rib
  • Rotator cuff or other shoulder diseases
  • Rheumatic diseases
  • Diabetes
  • Psychiatric diseases
  • Vascular diseases
  • Cancer
  • Infectious diseases
  • Skin abrasion
  • Pregnancy or breastfeeding
  • Recent injuries
  • Known sensibility to Laser therapy
  • Epilepsy
  • Anticoagulant therapy
  • Pacemaker
  • hemorrhagic diathesis
  • Photosensitizing drugs
  • Known Photosensibility
  • Neck Tattoos

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laser therapy
Multiwave locked system laser therapy
Other: Laser therapy
Multiwave locked system laser therapy
Placebo Comparator: Sham laser therapy
Other: Sham laser therapy
Sham laser therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neck pain
Time Frame: Change from baseline neck pain at 3 and 7 weeks
Eleven point (0-10) visual analogue scale
Change from baseline neck pain at 3 and 7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Disability
Time Frame: Change from baseline disability at 3 and 7 weeks
Neck disability index questionnaire
Change from baseline disability at 3 and 7 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neck mobility
Time Frame: Change from baseline neck mobility at 3 and 7 weeks
Degree of head rigth/left flexion, forward/backward flexion and rigth/left rotation, together with the velocity of the movements measured with an accelerometer
Change from baseline neck mobility at 3 and 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2022

Primary Completion (Actual)

November 11, 2022

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

June 28, 2022

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MLS LASER-neck

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Non-specific Neck Pain

Clinical Trials on Laser therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe