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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Gaziantep
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- change from baseline in pain on the 10 point visual analogue scale (VAS) at week 3
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
GRR laser
patients received 15 sessions GRR laser treatment for 3 weeks
Intervention: GRR laser (Device)
Nd:YAG Laser
patients received 10 sessions Nd:YAG laser treatment for 2 weeks
Intervention: Nd:YAG laser (Device)
placebo
patients received 10 sessions emission-free laser treatment for 2 weeks
Intervention: Nd:YAG laser (Device)
Outcomes
Primary Outcomes
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
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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
İREM KARAGOZOGLU
Assist. Prof.
University of Gaziantep