Photobiomodulation in the Management of Myofascial Pain: A Randomized and Blinded Clinical Trial

NCT07460895 NA NOT_YET_RECRUITING

This randomized clinical trial aims to evaluate the effectiveness of photobiomodulation therapy (PBM) alone or combined with therapeutic exercises compared with placebo PBM associated with exercises in patients with myofascial temporomandibular disorders (TMD). Participants will be allocated into three groups: PBM alone, PBM combined with exercises, or placebo PBM combined with exercises. The intervention consists of 12 treatment sessions. Outcomes related to pain intensity, mandibular function, and clinical measures will be assessed over time. The study seeks to investigate whether PBM provides additional benefits in pain reduction and functional improvement in individuals with myofascial TMD.

Details

Lead sponsor	Federal University of Rio Grande do Sul
Phase	NA
Status	NOT_YET_RECRUITING
Enrolment	140
Start date	2026-03-10
Completion	2030-12

Conditions

• Photobiomodulation
• Temporomandibular Disorder (TMD)
• Myofacial Pain
• Pain Management

Interventions

• Photobiomodulation Therapy
• Therapeutic Exercises
• Sham Photobiomodulation Therapy

Primary outcomes

• Assessment of Myofascial Pain Intensity — Baseline, throughout the 12 intervention sessions over 4 weeks, and at 1-month and 3-month follow-up assessments.
  Myofascial pain intensity will be assessed using the Visual Analog Scale for Pain, ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst pain imaginable," with higher scores representing worse pain. Participants will rate (1) worst pain experienced in the previous 24 hours and (2) pain evoked by standardized clinical palpation. Palpation will be performed bilaterally on the masseter and temporalis muscles and on the temporomandibular joint region, using controlled and standardized pressure applied for approximately 2 seconds per palpation point by a trained examiner.