Effect of Pain Science Education Administered in Full or Fractioned Dosage Modes Associated With Conventional Treatment on Pain Intensity and Disability for Temporomandibular Disorders: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Change in Pain intensity
研究概览
简要总结
Temporomandibular Disorders (TMD) are a collection of musculoskeletal disorders which affect the masticatory structures and have a multifactorial etiology. A biopsychosocial approach is recommended for the management of these disorders including different interventions like exercise, manual therapy and pain education. The aim of this study is to compare the effect of a full dosage mode pain science education program (2 initial sessions of 45 minutes) versus a fractioned dosage format (6 sessions of 15 minutes) combined with manual therapy and orofacial exercises on primary outcomes - pain intensity and disability - and secondary outcomes - mandibular range of motion, pain-related self-efficacy, kinesiophobia, global perception of improvement, empathy, knowledge about pain neuroscience, beliefs about pain, exercise adherence, and catastrophizing - in patients with chronic painful TMD. This study will be a randomized controlled trial with a sample of 148 participants. Individuals will undergo a screening process to identify those with TMD diagnosis according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), aged 20 to 60 years, of both genders, and then the volunteers will be randomized into two groups (G1: Full dosage mode pain science education program + Manual therapy/orofacial and neck motor exercises vs. G2: Fractioned dosage mode pain science education program + Manual therapy/orofacial and neck motor exercises). These volunteers will be recruited in the city of São Carlos, SP. The intervention will take place twice a week for 8 weeks, administered by a single therapist, each session lasting 1 hour. The primary outcomes will be pain intensity and disability, assessed using the numerical pain rating scale and the Craniofacial Pain and Disability Inventory (CFP-DI), respectively, and the secondary outcomes will be mandibular range of motion, pain-related self-efficacy, kinesiophobia, global perception of improvement, empathy, knowledge about pain neuroscience, beliefs about pain, exercise adherence, and catastrophizing, assessed using the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD), Global Perceived Effect of Improvement scale, Pain Self-Efficacy Questionnaire (PSEQ), CARE Empathy Scale, and Pain Catastrophizing Scale (PCS). For statistical analysis, a Generalized Estimated Equations considering time and groups as factors will be used. A significance level of p<0.05 will be considered.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 20 and 60 years;
- •painful TMD (confirmed by applying DC/TMD);
- •complaint of pain with a minimum intensity of 3 (on a scale of 0 to 10) present for at least 3 months;
- •fluency to speak and understand Brazilian Portuguese (Mini Cog instrument to assess cognitive capacity and the Cloze Test to certify textual reading comprehension)
排除标准
- •history of tumors in the orofacial region;
- •central and peripheral neurological diseases;
- •uncontrolled psychiatric illnesses;
- •pregnant women;
- •presence of toothache, neuralgia or chronic painful conditions in the head region, orofacial region or systemic pain (for example, fibromyalgia, osteoarthritis, osteoarthritis or rheumatological diseases);
- •report of previous major surgeries in the craniofacial region, such as orthognathic surgeries, TMJ surgeries, or resulting from post-trauma corrections;
- •history of major trauma involving the cervical or craniofacial region (facial trauma, whiplash injuries, etc.);
- •individuals undergoing physiotherapeutic treatment up to 6 months before the start of this study.
结局指标
主要结局
Change in Pain intensity
时间窗: Immediately after treatment, three-, six- and twelve- month follow-up
The Numerical Pain Rating Scale will be used to assess pain intensity in this trial. It consists of a sequence of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable".
Change in Orofacial Pain related Disability
时间窗: Immediately after treatment, three-, six- and twelve- month follow-up
The Craniofacial Pain and Disability Inventory (CF-PDI) is a self-administered questionnaire that measures the outcomes of pain and disability related to craniofacial pain. It demonstrated a good structure, internal consistency, reproducibility, and construct validity. Also, the Brazilian Portuguese version showed acceptable psychometric measurements. It consists of 21 items, with a score ranging from 0 to 63 points. Each question is scored on a 4-point ordinal scale, ranging from 0 to 3. A higher score reflects higher disability levels.
次要结局
- Change in Global Perceived Effect of Improvement(Immediately after treatment, three-, six- and twelve- month follow-up)
- Change in Pain-Related Self-efficacy(Immediately after treatment, three-, six- and twelve- month follow-up)
- Change in Kinesiophobia(Immediately after treatment, three-, six- and twelve- month follow-up)
- Status of Empathy with the care provider(Immediately after treatment)
- Previous and acquired knowledge about pain neuroscience(Immediately after treatment, three-, six- and twelve- month follow-up)
- Previous and current exercise adherence behaviour(Immediately after treatment, three-, six- and twelve- month follow-up)
- Beliefs about pain(Immediately after treatment, three-, six- and twelve- month follow-up)
研究者
Thais Chaves
Ph.D
Universidade Federal de Sao Carlos