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Completed

NCT Number: NCT05753540

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

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.

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Key information

Conditions

Chronic Non-specific Neck Pain

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

LASER Therapy

Other

Multiwave locked system laser therapy

Sham laser therapy

Other

Sham laser therapy

Primary outcomes

  1. Change in Neck pain

    Time frame: Change from baseline neck pain at 3 and 7 weeks

    Eleven point (0-10) visual analogue scale

Secondary outcomes

  1. Change in Disability

    Time frame: Change from baseline disability at 3 and 7 weeks

    Neck disability index questionnaire

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 3, 2023
Registry last updated
May 22, 2023

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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