Quality of Life and Sleep in Patients With Temporomandibular Disorders. A Protocol for a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Sleep Quality (Pittsburgh Sleep Quality Index)
研究概览
简要总结
The aim of this study is to evaluate and compare the effects of two physiotherapeutic intervention programs on the quality of life in patients with Temporomandibular Disorders (TMD).
Study design: Randomized, longitudinal, and prospective clinical trial with two intervention groups.
Population: Subjects aged 18-65 years with subacute temporomandibular disorders.
详细描述
The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. A total of 30 subjects with Temporomandibular Disorders (TMD) will be selected and randomly assigned into two intervention groups.
The first group will receive a physiotherapy treatment based on a Manual Therapy program targeting the orofacial region, combined with a Cervical Therapeutic Exercise program. In contrast, the second group will receive a physiotherapy treatment based on a Manual Therapy program for the orofacial region, combined with an Orofacial Therapeutic Exercise program.
Both groups will undergo a total of six treatment sessions over a period of six weeks (1 session per week). Each manual therapy session targeting the orofacial region will last 30 minutes. The manual therapy (MT) techniques will include a combination of neuromuscular and articular manual techniques.
The study will assess the following variables: quality of life, sleep quality, pressure pain threshold, maximum pain-free mouth opening, perceived pain, and treatment adherence.
Measurements will be taken pre-treatment, post-treatment and a follow-up at 8 weeks
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 18 and 65 years of age with subacute Temporomandibular Disorders (TMD).
- •Diagnosis of TMD based on: The Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). And The Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
- •Willingness to participate in the study and signing of the informed consent form.
排除标准
- •Individuals younger than 18 years or older than 65 years.
- •Medical history or systemic conditions, including: Diagnosis of neurological or neuromuscular disorders (such as multiple sclerosis, facial paralysis, trigeminal neuralgia). Systemic or inflammatory joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia). Presence of severe psychiatric disorders. Previous diagnosis of cancer in the craniofacial or cervical region.
- •Previous interventions (e.g., surgery involving the TMJ or the orofacial and cervical regions).
- •History of trauma in the region, including mandibular trauma, whiplash injuries, or fractures in the area.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Group 1
Subjects in this group will receive physiotherapy treatment consisting of a Manual Therapy program targeting the orofacial region, combined with a Cervical Therapeutic Exercise program. The Cervical Therapeutic Exercise program focuses on co-contraction exercises of the flexor and extensor muscles, progressively increasing difficulty and resistance through the use of a latex band (Theraband), along with neural tissue techniques.
干预措施: Manual Therapy and Therapeutic Exercises Programs (Other)
Group 2
Subjects in this group will receive physiotherapy treatment consisting of a Manual Therapy program targeting the orofacial region, combined with an Orofacial Therapeutic Exercise program. The Orofacial Therapeutic Exercise program focuses on coordination exercises of the masseter muscles, progressively increasing difficulty and resistance, and is combined with neural tissue techniques.
干预措施: Manual Therapy and Therapeutic Exercises Programs (Other)
结局指标
主要结局
Sleep Quality (Pittsburgh Sleep Quality Index)
时间窗: Pre- intervation, post-intervention (6 weeks) and follow-up of 8 weeks after the end.
The Pittsburgh Sleep Quality Index (PSQI) is a self-administered instrument designed to assess sleep quality in adults over the past month. It consists of 19 items grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
Quality of Life (SF-12)
时间窗: Pre-intervention, post-intervention (6 weeks) and follow-up of 8 weeks after the end
The SF-12 consists of a subset of 12 items from the SF-36, covering physical functioning, social functioning, physical role, emotional role, mental health, vitality, bodily pain, and general health. The SF-12 is a shortened version of the SF-36 Health Survey. It is a self-administered questionnaire with a completion time of less than 2 minutes. The response options are based on Likert-type scales that assess intensity or frequency. The number of response options ranges from three to six, depending on the item.
次要结局
- Pain Intensity (NRS)(Pre- intervention, post- intervention (6 weeks) and follow-up of 8 weeks after the end)
- Pressure Pain Threshold (PPT)(Pre- intervention, post- interventio (6 weeks) and follow-up of 8 weeks after the end.)
- Maximum Pain-Free Mouth Opening (MPMO)(Pre- intervention, post- intervention (6 weeks) and follow-up of 8 weeks after the end.)
- Treatment Adherence(Post- intervention (6 weeks))
研究者
Alexander Achalandabaso
Clinical Professor
University of Jaén