New Generation Low Level Laser Effect in Myofacial Pain Syndrome

NCT06442553 | Completed

• 1 other identifier: KARAGOZOGLUI
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myofascial Pain Syndrome

Keywords

low level laser therapy; myofascial pain syndrome; bite forces; visual analogue scale; gaalas laser; neodymium doped yttrium aluminum garnet lasers

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

GRR laser

EXPERIMENTAL

patients received 15 sessions GRR laser treatment for 3 weeks

Device: GRR laser

Nd:YAG Laser

EXPERIMENTAL

patients received 10 sessions Nd:YAG laser treatment for 2 weeks

Device: Nd:YAG laser

placebo

PLACEBO COMPARATOR

patients received 10 sessions emission-free laser treatment for 2 weeks

Device: Nd:YAG laser

Interventions

GRR laser DEVICE

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

GRR laser

Nd:YAG laser DEVICE

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

Nd:YAG Laser; placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

İrem Karagözoğlu

Şehitkamil, Gazi̇antep, 27310, Turkey (Türkiye)

Location

Related Publications (1)

• Karagozoglu I, Demirkol N, Parlar Oz O, Yilmaz S, Ozcan M. 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. Lasers Med Sci. 2025 Jan 27;40(1):48. doi: 10.1007/s10103-024-04272-z.

  PMID: 39869221 DERIVED

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Study Officials

• İREM KARAGÖZOĞLU

  GAZİANTEP ÜNİVERSİTESİ DİŞ HEKİMLİĞİ FAKÜLTESİ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: January 15, 2024
• Primary Completion: March 25, 2024
• Study Completion: April 1, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)