A Randomized, Single-Blind Controlled Trial Investigating the Effect of Body Awareness Therapy on Pain, Functional Outcomes, and Psychosocial Parameters in Adults With Temporomandibular Joint Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Jaw Functional Limitation Scale (JFLS)
研究概览
简要总结
This randomized, single-blind controlled trial aims to investigate the effectiveness of Body Awareness Therapy (BAT) on pain, functional limitations, and psychosocial outcomes in individuals with temporomandibular joint disorders (TMD). TMD is characterized by orofacial pain, impaired jaw function, and increased psychosocial burden, yet current physiotherapy approaches may not fully address the biopsychosocial mechanisms underlying these symptoms. BAT is a structured mind-body physiotherapy intervention designed to improve postural awareness, interoceptive sensitivity, breathing regulation, and movement control.
In this study, participants will be randomly assigned to either BAT or a standard physiotherapy control intervention for a defined treatment period. Primary outcomes will include pain intensity and jaw functional limitations, while secondary outcomes will assess body awareness, anxiety, stress, and quality of life. Evaluations will be conducted at baseline and post-intervention. The findings of this trial may provide evidence for integrating biopsychosocial and awareness-based physiotherapy into TMD rehabilitation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-65 years. Diagnosed with Temporomandibular Joint Disorders (TMD) according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
- •Experiencing orofacial pain or jaw functional limitation for at least the past 3 months.
- •Ability to understand and follow verbal instructions required for Body Awareness Therapy sessions.
- •Willingness to participate in the study and to attend all assessment and intervention sessions.
- •Providing written informed consent.
排除标准
- •History of jaw trauma, fracture, or surgery within the past 6 months. Presence of systemic rheumatologic or inflammatory disorders (e.g., rheumatoid arthritis, ankylosing spondylitis) that may affect TMJ function.
- •Neurological or psychiatric conditions that could interfere with participation or outcome assessments (e.g., major psychiatric disorder, cognitive impairment).
- •Severe dental or orthodontic conditions requiring immediate treatment (e.g., acute infection, ongoing orthodontic procedures).
- •Use of occlusal splints, bite guards, or other TMJ-related interventions initiated within the past 3 months.
- •Participation in any other physiotherapy or exercise program targeting the jaw, cervical spine, or posture during the study period.
- •Pregnancy, due to potential changes in joint laxity and pain perception. Current use of medications affecting neuromuscular or pain responses, such as muscle relaxants, corticosteroids, or neuropathic pain medications (unless dose has been stable for 3 months).
- •Any contraindication to performing light-to-moderate physical activity or awareness-based exercises.
- •Inability to attend scheduled therapy sessions or complete study assessments.
研究组 & 干预措施
Body Awareness Therapy (BAT)
Participants will receive Body Awareness Therapy
干预措施: Body Awareness Therapy (Behavioral)
Body Awareness Therapy (BAT)
Participants will receive Body Awareness Therapy
干预措施: Standard Physiotherapy (Other)
Standard Physiotherapy
Participants will receive standard physiotherapy
干预措施: Standard Physiotherapy (Other)
结局指标
主要结局
Jaw Functional Limitation Scale (JFLS)
时间窗: Baseline, post-intervention (8 weeks)
Jaw functional limitation assessed by the Jaw Functional Limitation Scale (JFLS). Change in jaw-related functional limitation measured using the Jaw Functional Limitation Scale (JFLS), a validated self-report questionnaire assessing limitations in mastication, jaw mobility, and verbal communication. The total score ranges from 0 to 200, with higher scores indicating greater functional limitation (worse outcome).
Hospital Anxiety and Depression Scale
时间窗: Baseline, post-intervention (8 weeks)
Change in anxiety and depression levels measured using the Hospital Anxiety and Depression Scale (HADS), a validated 14-item self-report questionnaire. The anxiety (HADS-A) and depression (HADS-D) subscales are each scored from 0 to 21, with higher scores indicating greater symptom severity (worse outcome).
次要结局
未报告次要终点
研究者
Seda Karaca
Principal Investigator, Doctor Lecturer
Recep Tayyip Erdogan University