Lifestyle Counseling vs. Clinical Pilates in Women With Temporomandibular Disorders

NCT07345351 | Enrolling By Invitation

• 1 other identifier: PBE2025-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of lifestyle counseling alone compared to lifestyle counseling combined with Clinical Pilates in women with temporomandibular disorders (TMD). The study also aims to examine the effects of these interventions on pain, jaw function, posture, oral behaviors, psychological status, sleep quality, and quality of life. The main questions this study aims to answer are: Does adding Clinical Pilates to lifestyle counseling reduce pain levels in women with TMD more than lifestyle counseling alone? Does the combined intervention improve jaw function, head posture, and oral behaviors? What are the effects of these interventions on anxiety, sleep quality, and quality of life? Researchers will compare lifestyle counseling alone with lifestyle counseling combined with a supervised Clinical Pilates program to determine whether the addition of Clinical Pilates provides greater clinical and psychosocial benefits. Participants will be randomly assigned to one of two groups:

• Receive lifestyle counseling only (control group), or
• Participate in a supervised Clinical Pilates program twice weekly for 8 weeks in addition to lifestyle counseling (intervention group) Undergo assessments at baseline (before any intervention) and after completion of the interventions. Outcome measures will include assessments of pain, jaw function, posture, oral behaviors, psychological status, sleep quality, and quality of life.

Conditions

Counseling; Health Counseling; Behavior Therapy

Keywords

Temporomandibular Disorders; Lifestyle Counseling; Clinical Pilates; Women's Health; Jaw Function; Functional Limitation

Outcome Measures

Primary Outcomes (9)

• Visual Analog Scale (VAS)

  Participants will be asked to mark their pain on a line ranging from 0 (no pain) to 10 (unbearable pain). Pain will be measured at rest and as palpation-induced pain (before and after palpation).

  Each participant in the group will be evaluated twice. The first assessment will be conducted at the very beginning of the study before any intervention, and the second assessment will be performed after the interventions have been completed.

• Graded Chronic Pain Scale Version 2.0

  The scale provides a simple, practical, and versatile assessment and is included in the DC/TMD diagnostic criteria. It consists of 8 questions: 3 questions assess pain intensity, 4 questions assess pain-related disability, and 1 question determines the number of painful days. For all questions except the 1st and 5th, participants are asked to rate their pain on a scale from 0 ("no pain") to 10 ("worst pain imaginable").

  Each participant in the group will be evaluated twice. The first assessment will be conducted at the very beginning of the study before any intervention, and the second assessment will be performed after the interventions have been completed.

• Jaw Functional Limitation Scale-20

  This is the most widely used self-report questionnaire for assessing jaw functional limitation in TMD. It is included among the recommended measures in the DC/TMD. The scale has three subscales evaluating masticatory function, jaw movements, and social/functional impact. It is scored using a 0-10 Likert scale. The Turkish version has proven reliability and validity (Yıldız, Kocaman, \& Bingöl, 2024).

  Each participant in the group will be evaluated twice. The first assessment will be conducted at the very beginning of the study before any intervention, and the second assessment will be performed after the interventions have been completed.

• Maximum Mouth Opening

  This is one of the objective indicators of functional limitation. A normal value is considered to be ≥40 mm. Participants will be asked to open their mouth as wide as possible, and the measurement will be taken using a caliper.

  Each participant in the group will be evaluated twice. The first assessment will be conducted at the very beginning of the study before any intervention, and the second assessment will be performed after the interventions have been completed.

• Craniovertebral Angle Measurement

  This is a simple and clinically meaningful postural assessment method that provides information about head posture by measuring the forward position of the head. The angle between the line connecting the tragus (the prominence in front of the ear) and the C7 spinous process (lower part of the neck) and the horizontal plane is measured. A normal value is considered ≥48°. Values less than 48° are recorded as forward head posture (head anterior tilt) (Shaghayeghfard et al., 2016).

  Each participant in the group will be evaluated twice. The first assessment will be conducted at the very beginning of the study before any intervention, and the second assessment will be performed after the interventions have been completed.

• Oral Habits Checklist

  Recommended in the DC/TMD protocol, this checklist is used to assess sleep and daytime bruxism as well as other parafunctional habits (e.g., pencil biting, nail biting) (Ohrbach \& Dworkin, 2017).

  Each participant in the group will be evaluated twice. The first assessment will be conducted at the very beginning of the study before any intervention, and the second assessment will be performed after the interventions have been completed.

• Generalized Anxiety Disorder-7 Questionnaire (GAD-7)

  This tool is used to screen for generalized anxiety disorder and measure the severity of general anxiety levels. It consists of 7 questions. Participants are asked how often they have experienced anxiety symptoms over the past two weeks. The scoring for each item is as follows: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. The total score ranges from 0 to 21, with the following interpretations: 0-4 = Minimal anxiety, 5-9 = Mild anxiety, 10-14 = Moderate anxiety, and 15-21 = Severe anxiety (Konkan et al., 2013).

  Each participant in the group will be evaluated twice. The first assessment will be conducted at the very beginning of the study before any intervention, and the second assessment will be performed after the interventions have been completed.

• Patient Health Questionnaire-15 (PHQ-15)

  Used to assess the frequency and severity of somatic (physical) symptoms and commonly applied for screening somatization disorder. Participants are asked how often they have experienced these symptoms over the past 4 weeks. The questionnaire includes 15 common physical symptoms (e.g., headache, stomach problems, fatigue, sleep disturbances). Each item is scored as 0 = Not at all, 1 = A little, and 2 = A lot. The total score ranges from 0 to 30, with the following interpretations: 0-4 = Low somatic symptom severity, 5-9 = Mild, 10-14 = Moderate, and 15 or higher = Severe somatic symptoms.

  Each participant in the group will be evaluated twice. The first assessment will be conducted at the very beginning of the study before any intervention, and the second assessment will be performed after the interventions have been completed.

• Pittsburgh Sleep Quality Index (PSQI)

  Participants' sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The questionnaire consists of 24 items: 19 self-reported questions addressing factors related to sleep quality, and 5 items answered by a spouse or roommate. The 5 spouse/roommate items are clinically evaluated but not included in scoring. The 19 self-report items measure seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each question is scored from 0 to 3. The total PSQI score (ranging from 0 to 21) is calculated by summing the seven component scores. A total score of 5 or below indicates good sleep quality, while a score above 5 indicates poor sleep quality (Ağargün, Kara, \& Anlar, 1996).

  Each participant in the group will be evaluated twice. The first assessment will be conducted at the very beginning of the study before any intervention, and the second assessment will be performed after the interventions have been completed.

Study Arms (2)

Arm 1: Life Counselling

ACTIVE COMPARATOR

Behavioral: Life Counselling

Arm 2: Life Counselling + Clinical Pilates

EXPERIMENTAL

Behavioral: Life Counselling; Behavioral: Clinical Pilates

Interventions

Life Counselling BEHAVIORAL

Participants receive individualized lifestyle counseling focused on stress management, physical activity, and sleep hygiene. Counseling sessions are conducted weekly for 8 weeks, delivered by a trained healthcare professional. The aim is to improve overall health behaviors related to temporomandibular disorder symptoms.

Arm 1: Life Counselling; Arm 2: Life Counselling + Clinical Pilates

Clinical Pilates BEHAVIORAL

Participants receive the same lifestyle counseling described above, combined with supervised clinical Pilates sessions. Pilates exercises focus on strengthening the core and improving posture and jaw function, conducted twice weekly for 8 weeks.

Arm 2: Life Counselling + Clinical Pilates

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18-45
• Diagnosed with TMD (according to DC/TMD diagnostic criteria)
• Experiencing TMD symptoms for the past 3 months
• Have not previously received Pilates or lifestyle counseling
• Without any condition preventing exercise
• Diagnosed with muscle-related TMD

You may not qualify if:

• Rheumatological diseases
• Neurological disorders
• Pregnancy
• History of head or neck trauma
• Diagnosed with joint-related TMD (with or without reduction)

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Hatay Mustafa Kemal University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department

Hatay, 31000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Researcher, Head of Physiotherapy and Rehabilitation Department, Hatay Mustafa Kemal University

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 15, 2026
• Study Start: July 17, 2025
• Primary Completion: October 17, 2025
• Study Completion: February 15, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

TU (1)