Temporomandibular Disorders (TMD)
Conditions
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.
Interventions
OTHERPilates
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
OTHEREducation and home exercise
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.
Sponsors
Toros University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Masseter muscle Pressure-Pain Threshold (PPT) | Baseline: week 0 / At the end of Week 8: Second and final assessment | 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. |
| Upper Trapezius Pressure-Pain Threshold | Baseline: week 0 / At the end of Week 8: Second and final assessment] | 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. |
| Tibialis Anterior Muscle Pressure-Pain Threshold | Baseline: week 0 / At the end of Week 8: Second and final assessment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Temporomandibular Joint Range of Motion | Baseline: week 0 / At the end of Week 8: Second and final assessment | The TheraBite® Range of Motion Scale (TheraBite®, Platon Medical Ltd., UK) will be used to assess temporomandibular joint (TMJ) range of motion. TheraBite is widely used in both research and clinical practice and is considered a standard, highly reliable tool for measuring jaw mobility. Participants, seated in an upright position, will be asked to open their mouths as wide as possible, and measurements will be recorded in millimeters. Each assessment will be repeated three times, and the average value will be used for analysis. |
| Cranio-cervical posture | Baseline: week 0 / At the end of Week 8: Second and final assessment | Cranio-cervical posture will be assessed using cranio-cervical angle measurement through a photogrammetric method. Reference points, including the spinous process of the seventh cervical vertebra and the tragus of the ear, will be marked before photographing. Participants will perform repeated neck flexion and extension movements to achieve a neutral head position, then be photographed from the left side at a distance of 1.5 meters with a tripod-mounted smartphone camera. The cranio-cervical angle will be calculated using ImageJ software by measuring the angle between the horizontal line and a line connecting the C7 spinous process and the ear tragus. |
| Quality of life (QoL) | Baseline: week 0 / At the end of Week 8: Second and final assessment | Quality of life will be assessed using the Short Form-36 (SF-36) questionnaire, which evaluates overall health status. It is simple, easy to administer, and suitable for different populations. Scores range from 0 to 100, with higher scores indicating better quality of life. |
| TMJ Pain | Baseline: week 0 / At the end of Week 8: Second and final assessment | Pain in the temporomandibular joint will be evaluated using the Graded Chronic Pain Scale (GCPS). The scale classifies participants into four levels based on combined pain and disability scores, ranging from mild pain with minimal disability to severe pain with high disability. |
| Jaw Limitation | Baseline: week 0 / At the end of Week 8: Second and final assessment | To assess jaw limitations Jaw Functional Limitation Scale-8 (JFLS-8) will be used.The JFLS-8 includes 8 items that measure difficulty in jaw-related functions, rated on a scale from 0 ("No Limitation") to 10 ("Severe Limitation"). Higher scores indicate greater dysfunction and limitation. |
| Depression | Baseline: week 0 / At the end of Week 8: Second and final assessment | Depression levels of participants will be assessed using the Patient Health Questionnaire-4 (PHQ-4). The questionnaire consists of four items, and total scores range from 0 to 12. Higher scores indicate greater levels of depression. |
| Muscle Stiffness | Baseline: week 0 / At the end of Week 8: Second and final assessment | Stiffness \[N/m\], is a biomechanical property of a muscle, provides information about the resistance of the tissue to an external force or contraction. stiffness will be measured using a myotonometer (MyotonPRO, Myoton AS, Tallinn, Estonia), which has been reported to be valid and reliable. Assessments will be conducted in study, masseter, upper trapezius, tibialis anterior muscles.The measurement will be repeated 3 times and the arithmetic mean of the measurements will be recorded. |
| Logarithmic decrease | Baseline: week 0 / At the end of Week 8: Second and final assessment | Logarithmic decrease (D) gives information about the elasticity of the evaluated tissue. Logarithmic decrease will be measured using a myotonometer (MyotonPRO, Myoton AS, Tallinn, Estonia), which has been reported to be valid and reliable.Assessments will be conducted in study, masseter, upper trapezius, tibialis anterior muscles.The measurement will be repeated 3 times and the arithmetic mean of the measurements will be recorded. |
| Stress hormon levels | Baseline: week 0 / At the end of Week 8: Second and final assessment | The stress and anxiety levels of participants evaluated in the study will also be assessed by measuring salivary cortisol levels. In this study, blue-capped SARSTEDT Salivette tubes, specifically designed for cortisol collection, will be used for sample collection and storage. These tubes ensure high analytical performance even with small sample volumes. Participants will be asked to chew the special swab inside the blue-capped tube, made of Polypropylene (PP)/Low Density Polyethylene (LD-PE), for two minutes to stimulate saliva production, after which the swab containing absorbed saliva will be placed back into the collection tube. Salivary cortisol levels will be analyzed from the collected samples using the ECLIA method. |
| Cervical Pain | Baseline: week 0 / At the end of Week 8: Second and final assessment | Pain intensity at the cervical region will be assessed using the Visual Analog Scale (VAS), where participants will mark their pain level on a 100 mm horizontal line, and scores will be recorded in millimeters. |
| Anxiety Levels | Baseline: week 0 / At the end of Week 8: Second and final assessment | Anxiety levels of participants will be assessed using the Patient Health Questionnaire-4 (PHQ-4). The questionnaire consists of four items, and total scores range from 0 to 12. Higher scores indicate greater levels of anxiety. |
| TMJ Dysfunction Severity | Baseline: week 0 / At the end of Week 8: Second and final assessment | TMJ dysfunction severity will be assessed with Fonseca Anamnestic Index (FAI). The FAI consists of 10 questions with "yes," "no," and "sometimes" answer options, scored as 10, 0, and 5 points respectively, to determine the severity of temporomandibular disorder symptoms. Higher scores indicate greater TMJ dysfunction severity. |
Countries
Turkey (Türkiye)
Outcome results
None listed