New Generation Low Level Laser Effect in Myofacial Pain Syndrome

Myofascial Pain Syndrome Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06442553
• Other study ID #: KARAGOZOGLUI
• Status: Completed
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: April 1, 2024

Study information

• Verified date: May 2024
• Source: University of Gaziantep
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 1, 2024
• Est. primary completion date: March 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Facial Neuralgia
• Facial Pain
• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Somatoform Disorders
• Syndrome

Intervention

Device:
• GRR laser
A total of 15 sessions were applied to each patient for three weeks, five times per week.
• Nd:YAG laser
A total of 10 sessions, five sessions per week, were applied

Locations

Country	Name	City	State
Turkey	Irem Karagözoglu	Sehitkamil	Gazi?antep

Sponsors (1)

Lead Sponsor	Collaborator
University of Gaziantep

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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