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

NCT ID: NCT05753540

Last Updated: 2023-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2023-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Non-specific Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Laser therapy

Multiwave locked system laser therapy

Group Type EXPERIMENTAL

Laser therapy

Intervention Type OTHER

Multiwave locked system laser therapy

Sham laser therapy

Sham laser therapy

Group Type PLACEBO_COMPARATOR

Sham laser therapy

Intervention Type OTHER

Sham laser therapy

Interventions

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Laser therapy

Multiwave locked system laser therapy

Intervention Type OTHER

Sham laser therapy

Sham laser therapy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Lisa Berti

Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status

Countries

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Italy

Other Identifiers

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MLS LASER-neck

Identifier Type: -

Identifier Source: org_study_id

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