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

Primary Purpose

Chronic Non-specific Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Laser therapy
Sham laser therapy
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Non-specific Neck Pain

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IRCCS Istituto Ortopedico Rizzoli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Laser therapy

Sham laser therapy

Arm Description

Multiwave locked system laser therapy

Sham laser therapy

Outcomes

Primary Outcome Measures

Change in Neck pain
Eleven point (0-10) visual analogue scale

Secondary Outcome Measures

Change in Disability
Neck disability index questionnaire

Full Information

First Posted
June 28, 2022
Last Updated
May 19, 2023
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT05753540
Brief Title
The Effects of MLS LASER Therapy in Patients With Chronic Nonspecific Neck Pain
Official Title
Pilot Study on the Effects of MLS (Multiwave Locked System) LASER Therapy in Patients With Chronic Nonspecific Neck Pain: Randomized Controlled Trial Versus Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
November 11, 2022 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Non-specific Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser therapy
Arm Type
Experimental
Arm Description
Multiwave locked system laser therapy
Arm Title
Sham laser therapy
Arm Type
Placebo Comparator
Arm Description
Sham laser therapy
Intervention Type
Other
Intervention Name(s)
Laser therapy
Intervention Description
Multiwave locked system laser therapy
Intervention Type
Other
Intervention Name(s)
Sham laser therapy
Intervention Description
Sham laser therapy
Primary Outcome Measure Information:
Title
Change in Neck pain
Description
Eleven point (0-10) visual analogue scale
Time Frame
Change from baseline neck pain at 3 and 7 weeks
Secondary Outcome Measure Information:
Title
Change in Disability
Description
Neck disability index questionnaire
Time Frame
Change from baseline disability at 3 and 7 weeks
Other Pre-specified Outcome Measures:
Title
Change in Neck mobility
Description
Degree of head rigth/left flexion, forward/backward flexion and rigth/left rotation, together with the velocity of the movements measured with an accelerometer
Time Frame
Change from baseline neck mobility at 3 and 7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
IRCCS Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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