New Generation Low Level Laser Effect in Myofacial Pain Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Myofascial Pain Syndrome
• Intervention / Treatment: Device: GRR laser; Device: Nd:YAG laser

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Gazi̇antep
    • Şehitkamil, Gazi̇antep, Turkey, 27310
      • İrem Karagözoğlu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GRR laser; patients received 15 sessions GRR laser treatment for 3 weeks	Device: GRR laser; A total of 15 sessions were applied to each patient for three weeks, five times per week.
Experimental: Nd:YAG Laser; patients received 10 sessions Nd:YAG laser treatment for 2 weeks	Device: Nd:YAG laser; A total of 10 sessions, five sessions per week, were applied
Placebo Comparator: placebo; patients received 10 sessions emission-free laser treatment for 2 weeks	Device: Nd:YAG laser; A total of 10 sessions, five sessions per week, were applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in pain on the 10 point visual analogue scale (VAS) at 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	baseline and week 3
change from baseline in oxygen concentration in the massater muscle at 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.	baseline and week 3
change from baseline in bite force values at week 3	bite force values were recorded by Flexiforce sensors before and after treatment for each patient.	baseline and week 3

Collaborators and Investigators

• Sponsor: University of Gaziantep
• Investigators: Principal Investigator: İREM KARAGÖZOĞLU, GAZİANTEP ÜNİVERSİTESİ DİŞ HEKİMLİĞİ FAKÜLTESİ

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Actual): March 25, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: myofascial pain syndrome; low level laser therapy; visual analogue scale; bite forces; gaalas laser; neodymium doped yttrium aluminum garnet lasers
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Syndrome; Fibromyalgia; Somatoform Disorders; Myofascial Pain Syndromes; Facial Neuralgia; Facial Pain
• Other Study ID Numbers: KARAGOZOGLUI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No