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Temporomandibular Disorders (TMD)TMDNCT07750145

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

A study testing Pilates and Education and home exercise in people with Temporomandibular Disorders (TMD), run by Toros University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Temporomandibular Disorders (TMD)
What is being tested?
Pilates and Education and home exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2025to 1 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Toros University

    Mersin

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Pilates On Women With Myogenic Temporomandibular Joint Dysfunction; A Randomised Controlled, Single-Blind Study

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.

Read more

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.

Being tested
Pilates, Education and home exercise
Medical subject headings
Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PilatesOther

    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

  • Education and home exerciseOther

    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.

Study groups in NCT07750145
Study groupRoleWhat they receive
PilatesExperimentalParticipants 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.
Receives: Other: Pilates
ControlActive comparatorParticipants 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.
Receives: Other: Education and home exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (12)
  1. Temporomandibular Joint Range of Motion

    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.

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

  2. Cranio-cervical posture

    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.

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

  3. Quality of life (QoL)

    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.

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

  4. TMJ Pain

    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.

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

  5. Jaw Limitation

    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.

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

  6. Depression

    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.

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

  7. Muscle Stiffness

    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.

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

  8. Logarithmic decrease

    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.

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

  9. Stress hormon levels

    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.

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

  10. Cervical Pain

    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.

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

  11. Anxiety Levels

    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.

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

  12. TMJ Dysfunction Severity

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2026
  2. Study start1 Oct 2025
  3. Primary completion1 Jan 2026
  4. Study completion1 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07750145
Sponsor's protocol ID
TU-UY-FTR-02
Acronym
TMD
Status last verified
Aug 2026
First submitted
4 Sep 2025
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Pilates and Education and home exercise in people with Temporomandibular Disorders (TMD), run by Toros University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Masseter muscle Pressure-Pain Threshold (PPT) (time frame: Baseline: week 0 / At the end of Week 8: Second and final assessment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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