Clinical Trial

The Effects of Pilates Exercises on Women With Myogenic Temporomandibular Joint Dysfunction: A Randomised Controlled, Single-Blind Study

Study acronym: TMD
Completed
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Summary
The aim of this study is to investigate the effects of an 8-week Pilates exercise program on pain, pressure-pain threshold, temporomandibular joint (TMJ) range of motion, cervical posture, stress levels, quality of life, jaw function and disability, depression, and muscle stiffness in women with myogenic temporomandibular disorders (TMD). Eligible volunteers will be recruited from Toros University students and staff through screening with the Fonseca Anamnestic Index and diagnostic criteria for TMD (DC/TMD Axis I). After informed consent, participants who meet the inclusion criteria will be randomly assigned to either a control or an intervention group. Control Group: Receives patient education (including information about parafunctional habits and sleep hygiene) and a standardized home exercise program to be performed three times per week for eight weeks. Compliance will be monitored weekly by phone calls and exercise logs. Intervention Group: Receives the same education and home exercise program plus supervised Pilates training, three sessions per week for eight weeks, each lasting approximately 60 minutes (including warm-up and cool-down). Sessions are delivered by a certified physiotherapist and structured progressively every two weeks. All participants will undergo a comprehensive baseline and post-intervention assessment by a blinded evaluator. Assessments include: Pressure-pain threshold (digital algometer) at masseter, trapezius, and tibialis anterior muscles Temporomandibular joint range of motion (TheraBite scale) Cranio-cervical posture (photogrammetry and ImageJ analysis) Pain intensity and disability (Visual Analog Scale, Graded Chronic Pain Scale) Jaw function and limitation (JFLS-8) Quality of life (SF-36) Depression and anxiety levels (PHQ-4) Muscle stiffness (MyotonPRO) Salivary cortisol analysis for stress evaluation Participants are excluded if they have systemic, neurological, psychiatric, or dental conditions; recent orthodontic treatment or trauma; ongoing use of pain medication; prior Pilates training in the past six months; or other factors that may affect assessment outcomes. Data will be analyzed using SPSS (v26) with appropriate parametric and non-parametric tests, and statistical significance will be set at p\<0.05. The study is designed as a single-blind, randomized controlled trial and will provide evidence on whether Pilates can be recommended as a complementary therapy in the management of myogenic TMD.
Trial Details
NCT Number NCT07750145
Lead Sponsor Toros University
Conditions Temporomandibular Disorders (TMD)
Enrollment 40 participants
Start Date 2025-10-01
Primary Completion 2026-01-01 (estimated)
Study Completion 2026-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-06