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

NCT07750145 | Completed

• 1 other identifier: TU-UY-FTR-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Temporomandibular Disorders (TMD)

Outcome Measures

Primary Outcomes (3)

• Masseter muscle Pressure-Pain Threshold (PPT)

  Pressure-pain threshold will be measured using a digital algometer (Commander Algometer, J-Tech Medical Industries, Salt Lake City, USA). Assessments will be performed bilaterally on the masseter muscles to evaluate regional pain sensitivity. After a practice trial, pressure will be applied with a 1 cm² probe at a rate of 1 kg/cm² per second until participants indicate the onset of pain, and the average of three trials taken 30 seconds apart will be recorded in kg/cm².

  Baseline: week 0 / At the end of Week 8: Second and final assessment

• Upper Trapezius Pressure-Pain Threshold

  Pressure-pain threshold will be measured using a digital algometer (Commander Algometer, J-Tech Medical Industries, Salt Lake City, USA). Assessments will be performed bilaterally on the uper trapezius muscles to evaluate regional pain sensitivity. After a practice trial, pressure will be applied with a 1 cm² probe at a rate of 1 kg/cm² per second until participants indicate the onset of pain, and the average of three trials taken 30 seconds apart will be recorded in kg/cm².

  Baseline: week 0 / At the end of Week 8: Second and final assessment]

• Tibialis Anterior Muscle Pressure-Pain Threshold

  Pressure-pain threshold will be measured using a digital algometer (Commander Algometer, J-Tech Medical Industries, Salt Lake City, USA). Assessments will be performed bilaterally on the masseter muscles to evaluate regional pain sensitivity. After a practice trial, pressure will be applied with a 1 cm² probe at a rate of 1 kg/cm² per second until participants indicate the onset of pain, and the average of three trials taken 30 seconds apart will be recorded in kg/cm².

  Baseline: week 0 / At the end of Week 8: Second and final assessment

Secondary Outcomes (12)

• Temporomandibular Joint Range of Motion

  Baseline: week 0 / At the end of Week 8: Second and final assessment

• Cranio-cervical posture

  Baseline: week 0 / At the end of Week 8: Second and final assessment

• Quality of life (QoL)

  Baseline: week 0 / At the end of Week 8: Second and final assessment

• TMJ Pain

  Baseline: week 0 / At the end of Week 8: Second and final assessment

• Jaw Limitation

  Baseline: week 0 / At the end of Week 8: Second and final assessment

Study Arms (2)

Pilates

EXPERIMENTAL

Participants in the experimental group will receive supervised Pilates training three times per week for eight weeks in addition to the patient education and home exercise program provided to the control group. They will first attend an introductory session covering core stabilization, pelvic alignment, breathing, and key Pilates principles, which they will be instructed to maintain throughout the exercises. Each 60-minute session will include a warm-up, progressive Pilates exercises performed in 3 sets of 10 repetitions, and a cool-down phase, with new movements introduced in weeks 3, 5, and 7. Exercises will be demonstrated, monitored, and corrected by a physiotherapist using verbal, tactile, and visual feedback.

Other: Pilates

Control

ACTIVE COMPARATOR

Participants in the control group will receive patient education on avoiding parafunctional habits and maintaining proper sleep hygiene, along with a standardized home exercise program. The home program will include heat application, self-massage, jaw stretching, strengthening exercises, and Rocabado 6x6 exercises. They will be instructed to perform these exercises three times per week for eight weeks and will be contacted weekly to monitor compliance. An exercise log will be provided and collected at the end of the intervention period.

Other: Education and home exercise

Interventions

Pilates OTHER

Participants in the experimental group will receive supervised Pilates training three times per week for eight weeks in addition to the patient education and home exercise program provided to the control group. They will first attend an introductory session covering core stabilization, pelvic alignment, breathing, and key Pilates principles, which they will be instructed to maintain throughout the exercises. Each 60-minute session will include a warm-up, progressive Pilates exercises performed in 3 sets of 10 repetitions, and a cool-down phase, with new movements introduced in weeks 3, 5, and 7. Exercises will be demonstrated, monitored, and corrected by a physiotherapist using verbal, tactile, and visual feedback

Pilates

Education and home exercise OTHER

Participants in the control group will receive patient education on avoiding parafunctional habits and maintaining proper sleep hygiene, along with a standardized home exercise program. The home program will include heat application, self-massage, jaw stretching, strengthening exercises, and Rocabado 6x6 exercises. They will be instructed to perform these exercises three times per week for eight weeks and will be contacted weekly to monitor compliance. An exercise log will be provided and collected at the end of the intervention period.

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18-50 years
• Diagnosed with myogenic temporomandibular disorder (TMD) based on standardized, valid, and reliable Diagnostic Criteria for TMD (DC/TMD Axis I)
• Presence of TMD-related symptoms for at least the past 6 months
• Resting pain intensity of ≥3 on the Visual Analog Scale (VAS)
• No regular participation in physical activity within the past 6 months
• Having natural dentition, defined as at least 10 natural teeth in both upper and lower jaws, confirmed by dental examination

You may not qualify if:

• Having received treatment related to TMD within the past year
• Needing dental treatment due to caries or periodontal disease
• Currently undergoing orthodontic treatment
• Having removable or fixed partial dentures
• Presence of other orofacial disease symptoms such as migraine or toothache
• Using a myorelaxant splint
• Having major psychosocial problems according to DC/TMD Axis II
• Having alcohol or drug addiction
• Being diagnosed with or receiving treatment for any psychiatric disorder
• Participation in Pilates sessions within the past 6 months
• Being pregnant
• Regular use of pain or anti-inflammatory medication
• Having systemic, rheumatic, endocrine, or connective tissue diseases
• History of trauma or surgery to the upper extremity, neck, orofacial region, or -head
• Presence of joint damage in the upper extremity, neck, orofacial region, or head

Sponsors & Collaborators

• Toros University: lead

Study Sites (1)

Toros University

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Exercise Movement Techniques; Educational Status

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: August 6, 2026
• Study Start: October 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)