Lifestyle Counseling vs. Clinical Pilates in Women With Temporomandibular Disorders

Official title

Effects of Lifestyle Counseling Versus Lifestyle Counseling Combined With Clinical Pilates in Women With Temporomandibular Disorders

Overview

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.

Detailed description

This study is a randomized controlled experimental trial designed, which investigates the effectiveness of Clinical Pilates when added to lifestyle counseling, aims to contribute to the literature by evaluating its potential role in the treatment planning of women with TMD. Within the scope of this research, the therapeutic effects of Clinical Pilates will be examined.

The study will include agree to participate voluntarily, and meet the study criteria.

Inclusion criteria:

* Female participants aged between 18 and 45 years * Diagnosed with temporomandibular disorder (according to DC/TMD diagnostic criteria) * Experiencing TMD-related complaints for at least the past 3 months * No prior experience with Pilates or lifestyle counseling * No contraindications to exercise * Diagnosed with muscle-related TMD

Exclusion Criteria:

* Presence of rheumatologic diseases * Neurological disorders * Pregnancy * History of head or neck trauma * Diagnosis of joint-related TMD (with or without reduction)

Participants will be randomly assigned into two groups:

* Group 1 (Control Group): Participants will receive lifestyle counseling only. * Group 2 (Intervention Group): In addition to lifestyle counseling, participants will take part in a Clinical Pilates exercise program twice a week for a total duration of 8 weeks.

To evaluate the effects of the interventions, pre and post-treatment assessments will be conducted using the following outcome measures:

* Visual Analog Scale (VAS) and Graded Chronic Pain Scale Version 2.0 (GCPS v2.0) for pain assessment, * Jaw Functional Limitation Scale-20 (JFLS-20) and Maximum Mouth Opening (MMO) for assessing jaw function, * Craniovertebral Angle Measurement for evaluating head posture, * Oral Behavior Checklist (OBC) for assessing oral parafunctions and bruxism, * Generalized Anxiety Disorder-7 (GAD-7) for psychological status, * Patient Health Questionnaire-15 (PHQ-15) for quality of life, * Pittsburgh Sleep Quality Index (PSQI) for sleep quality.

Treatment Program Lifestyle counseling will be delivered as a structured program focusing on stress management, sleep hygiene, oral habits, and nutritional behaviors. Clinical Pilates exercises will be tailored to each participant's symptoms and supervised by an experienced physiotherapist. It will be elaborated during the reporting phase of the study and written into the article.

Sample size The sample size is a critical component in the study, and its consideration is essential for the interpretation of the results.

The sample size of the study will be determined using the GPower 3.1.9 software (GPower, Universität Düsseldorf, Germany) with a statistical power of 85% and a type I error rate of 5%. As there is no existing study with an effect size that precisely matches the current research design, the effect size obtained from a pilot study will be used, and a post-hoc power analysis will be conducted to finalize the sample size.

Statistical Analysis Descriptive statistics are reported as mean and standard deviation or median and mode. Categorical variables are defined with numbers and percentages. The normality assumption is tested using the Shapiro-Wilks test and graphs (hygtogram, QQ plot, etc.). When comparing two groups, the independent groups t-test is used if the assumptions are met, and the Mann-Whitney U test is used if the assumptions are not met. Two-way analysis of variance for repeated measures is used when the assumptions are met, and Friedman's test is used when the assumptions are not met. Chi-squared tests will be used to determine whether there is a significant difference between categorical variables. Analyses will be performed using IBM SPSS v.21 and the significance level will be set at p\<0.05.

Interventions

• Behavioral Life Counselling
  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.
• Behavioral Clinical Pilates
  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.

Primary outcome measures

• Visual Analog Scale (VAS) [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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.]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Hatay Mustafa Kemal University, Faculty of Health Sciences, Physiotherapy and Rehabilitati — Antakya

Identifiers

NCT: NCT07345351 · PBE2025-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗