Skip to main content
OpenTrials
Completed

NCT Number: NCT06442553

New Generation Low Level Laser Effect in Myofacial Pain Syndrome

Low level laser treatments have been used to treat painful trigger points in myofascial pain syndrome (MPS), but the effectiveness of the appropriate laser type and parameters is still uncertain. The aim of this study was to compare the effectiveness of different types of low level laser treatment (LLLT) in reducing pain levels, changing oxygen saturation and bite force in patients with MPS.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myofascial Pain Syndrome Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İrem Karagözoğlu

Şehitkamil, Gazi̇antep, 27310, Turkey (Türkiye)

About this study

A total of 45 patients with MPS were randomly divided into three groups. First group received LLLT with GRR laser over massater muscle region. Patients in the second group were treated with Nd:YAG laser and the same protocol with Nd:YAG laser was performed in the placebo group using sham device. Pain was evaluated by visual analogue scale (VAS), change in oxygen concentration in the massater muscle was measured by functional near-infrared spectroscopy- fNIRS and bite force was measured with Flexiforce sensors before and after treatment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

-patients with symptoms of temporomandibular disorders and diagnosed with MPS as a result of the clinical examination.

Exclusion criteria

  • Patients with internal TMJ irregularities or degenerative joint changes,
  • patients with restricted mouth opening, deviation or deflection,
  • patients with systemic diseases,
  • pregnant women,
  • patients who had received MPS treatment within the previous year

Treatment and study plan

GRR laser

Device

A total of 15 sessions were applied to each patient for three weeks, five times per week.

Nd:Yag Laser

Device

A total of 10 sessions, five sessions per week, were applied

Primary outcomes

  1. change from baseline in pain on the 10 point visual analogue scale (VAS) at week 3

    Time frame: baseline and week 3

    Patients were asked to rate the intensity of their pain on a scale from 0 to 10. They were told that a score of 0 meant no pain, a score of 10 meant severe pain and a score of 5 meant moderate pain

  2. change from baseline in oxygen concentration in the massater muscle at week 3

    Time frame: baseline and week 3

    oxygen concentration in the massater muscle was measured by functional near-infrared spectroscopy- fNIRS (ARGES cerebro, Hemosoft Inc., Ankara, Turkey) before and after treatment for each patient.

  3. change from baseline in bite force values at week 3

    Time frame: baseline and week 3

    bite force values were recorded by Flexiforce sensors before and after treatment for each patient.

Sponsors and collaborators

Lead sponsor

University of Gaziantep

Other

Registry information

Official study title

New Generation Low Level Laser Effect on Masseter Muscle Oxygenation, Bite Force and Algometric Changes in Myofacial Pain Syndrome: A Randomised, Placebo-controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 4, 2024
Registry last updated
Jun 4, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.