Effects of Lifestyle Counseling Versus Lifestyle Counseling Combined With Clinical Pilates in Women With Temporomandibular Disorders
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Rheumatological diseases
- •Neurological disorders
- •Pregnancy
- •History of head or neck trauma
- •Diagnosed with joint-related TMD (with or without reduction)
研究组 & 干预措施
Arm 2: Life Counselling + Clinical Pilates
干预措施: Clinical Pilates (Behavioral)
Arm 1: Life Counselling
干预措施: Life Counselling (Behavioral)
Arm 2: Life Counselling + Clinical Pilates
干预措施: Life Counselling (Behavioral)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: 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.
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).
Graded Chronic Pain Scale Version 2.0
时间窗: 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.
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").
Jaw Functional Limitation Scale-20
时间窗: 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.
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).
Maximum Mouth Opening
时间窗: 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.
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.
Craniovertebral Angle Measurement
时间窗: 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.
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).
Oral Habits Checklist
时间窗: 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.
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).
Generalized Anxiety Disorder-7 Questionnaire (GAD-7)
时间窗: 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.
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).
Patient Health Questionnaire-15 (PHQ-15)
时间窗: 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.
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.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: 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.
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).
次要结局
未报告次要终点
研究者
Yasemin KARAASLAN
Principal Researcher, Head of Physiotherapy and Rehabilitation Department, Hatay Mustafa Kemal University
Mustafa Kemal University
