Additional Effect of Pain Neuroscience Education, Motor Imagery and Action Observation in Patients With Chronic Temporomandibular Disorders. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Craneofacial pain and disability inventory.
研究概览
简要总结
The objective of this study will be to verify the additional effect of Pain Neuroscience Education, Motor Imagery and Action Observation on primary outcomes pain intensity and craniofacial pain and disability in patients with chronic temporomandibular disorders (TMD). The secondary outcomes will be pressure pain threshold, temporal summation, conditioned pain modulation, central sensibilization, pain catastrophizing, kinesiophobia. This study will be a doble-blinded randomized clinical trial comprising a sample of 50 participants with orofacial pain of both genders and aged between 18 and 60 years. Subjects will undergo a screening process to identify those presenting a diagnosis of painful TMD confirmed by the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), and then they will be randomized into two groups (G1: Occlusal Splint, Counselling and Jaw and Neck Exercises vs. (G2: Occlusal Splint, Jaw and Neck Exercises plus Pain Neuroscience Education, Motor Imagery and Action Observation). These volunteers will be recruited from the Alisos Group Dentistry Clinic and University of Gran Rosario, (Rosario, Argentina). All patients will wear an occlusal splint designed by dentists. The interventions will be administered twice a week for 5 weeks by a single therapist. Subsequently, patients will be given instructions to perform the exercises at home for 5 weeks. Primary and secondary outcomes will be measured at baseline, 6 weeks and 12 weeks, and at 3 months after the end of treatment (follow-up). All the evaluations will be performed by a blinded physiotherapist.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of painful TMD using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
- •A history of orofacial pain during at least three months prior to the study
- •Age ranging between 18 to 65 years, both genders.
排除标准
- •Patients with neurological disorders (neuropathic pain or neurodegenerative disease), whiplash associated disorders, specific neck pain (radicular pain), recent dental or physical therapy. If patients are taking medication to relieve pain during the study, they will be encouraged to report it.
结局指标
主要结局
Change in Craneofacial pain and disability inventory.
时间窗: At baseline, then at six, twelve weeks, and 3 months follow-up.
The Craneofacial pain and disability inventory (CF-PDI) is a self-administered questionnaire that has been designed to obtain information on how pain in the orofacial region affects the patient's daily life. It consists of 21 items, with the final 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 pain and disability levels.
Change in Pain intensity.
时间窗: At baseline, then at six, twelve weeks, and 3 months follow-up.
The Numerical Pain Rating Scale (NPRS) will be used to assess pain intensity. This scale consists in a sequence of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable".
次要结局
- Change in Pressure Pain Threshold.(At baseline, then at six, twelve weeks, and 3 months follow-up)
- Change in Central Sensibilization Inventory.(At baseline, then at six, twelve weeks, and 3 months follow-up)
- Change in Conditioned Pain Modulation.(At baseline, then at six, twelve weeks, and 3 months follow-up)
- Change in Temporal Summation.(At baseline, then at six, twelve weeks, and 3 months follow-up)
- Change in Spanish version of the Tampa Scale of Kinesiophobia for Temporomandibular. Disorders(At baseline, then at six, twelve weeks, and 3 months follow-up)
- Change in Pain Catastrophizing Scale(At baseline, then at six, twelve weeks, and 3 months follow-up)
- Change in Home exercise adherence(Between the sixth and twelfth week (once per week))
研究者
Mauro Barone
PT
University of Gran Rosario