Orofacial Pain Self-management: Personality Moderation Effect - Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
The objective of this clinical trial is to study the effect of self-management on pain perception in patients with chronic orofacial pain and temporomandibular disorders (TMD) comparing it with the conventional treatment proposed by the TMD clinical practice guidelines. It also evaluates its effect on function and various psychosocial variables.
As a secondary objective, this work proposes to study the variability between patients, in terms of personality factors, as moderators of the effect of treatment on pain perception. Including in the proposed statistical models certain covariates such as perception and/or coping with stress, anxiety and other psychosocial variables.
This is a randomized clinical trial with two intervention groups and three measurement times (T0; pre-intervention, T1; post-5 weeks and T2; post-6 months). The experimental group will be applied a protocol based on self-management, which includes: therapeutic education, cognitive-behavioral tools, therapeutic exercise of the temporomandibular region, mind-body strategies and modifications of aspects related to lifestyle. The control group will carry out an intervention program based on the Clinical Practice Guidelines for the Management of Temporomandibular Joint Disorders. Therefore, using a set of tools based on therapeutic education, cognitive-behavioral tools for bruxism and other parafunctional habits, temporomandibular region exercises and manual therapy.
详细描述
Temporomandibular disorders (TMD) are the most common cause of chronic orofacial pain and encompass a range of syndromes affecting the masticatory muscles and temporomandibular joints (TMJ). Approximately 9-13% of the population experiences orofacial pain related to TMD. The high complexity, multifactorial nature, recurrence, and long duration of chronic pain increase the need for approaches focused on a multi-component management, based on learning strategies and coping skills, self-efficacy, and self-care. These approaches can be classified as self-management interventions, and their multifactorial nature makes them suitable for application and teaching by various health professionals. Within this multifactoriality, previous studies have shown that the patient's personality influences the occurrence and progression of chronic pain. The objective of this study is to evaluate a comprehensive self-management program in patients with chronic orofacial pain to assess its effect on pain perception and other psychosocial and functional variables, and subsequently analyze the moderation of factors related to the patient's personality on the intervention outcomes.
It is hypothesized that the self-management-based treatment is effective in reducing pain perception in the short and medium term, and that personality is a moderating factor for the intervention's effect.
The study will be conducted on 98 subjects aged 18 to 65, diagnosed with TMD and chronic orofacial pain. The intervention will last for 10 weeks with 5 sessions of application and 3 sessions of evaluation (pre-intervention; during the session time for the first intervention application session, post-5 weeks during the session time for the last intervention application session, and post-6 months; in an extra session dedicated solely to making the evaluation record). Each intervention session will be held once every two weeks. Results will be assessed using the EVA and GCPS questionnaires (pain), PCS (catastrophizing), TSK/TMD/S (kinesiophobia), FABQ (fear-avoidance), MFIQ (mandibular dysfunction), CPSS (self-efficacy), MMO (mandibular opening), Borg (perceived fatigue), BFQ (personality), CLCD (pain locus), COPE28 (stress coping), PSS (stress perception), STAI (anxiety), pressure algometry (pain threshold), intra-articular sound quantification, and treatment-seeking behavior.
All variables will be taken in triplicate at all three measurement times with the exception of the personality-related variable (BFQ). A descriptive statistical analysis of all variables in each of the intervention groups will be performed. To analyse the effect of the intervention on pain and the other secondary variables, a repeated-means ANOVA analysis will be performed between the self-management group (GSelfManagement) and the group based on the clinical practice guideline (GGuide). To examine whether variation in pain at follow-up is influenced by personality variables and/or the psychosocial variables kinesiophobia, catastrophising thoughts, fear-avoidance, type of pain control, perception of stress and anxiety, and stress coping, a moderation and mediation analysis will be performed. This analysis determines whether the effect size of a causal variable X (VAS and GCPS, MFIQ, MMO and VAS Fatigue) on outcome Y (GGuide and GSelfManagement), depends on a moderating or mediating variable W (i.e., kinesiophobia, catastrophizing, fear-avoidance, stress and anxiety perception, stress coping, personality and type of pain control). The degree of significance will be set at p<0.05. All analyses will be performed using statistical analysis software (SPSS 24 Inc, Chicago, Illinois, USA and The PROCESS macro for SPSS).
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •The patient presents TMDs diagnosed according to the CD/TMD classification.
- •Age between 18 and
- •Presence of pain in mandibular, temporal, facial, peri-auricular and/or auricular regions.
- •Presence of chronic orofacial pain. Defined by the ICD-11 as orofacial pain or headache that occurs for more than two hours a day for 50% of the days of the last three months.
- •Orofacial pain is related to TMDs according to the International Classification of Headaches.
- •Moderate pain intensity, corresponding to a weekly average of at least 30 mm on a 100 mm VAS (validated representation of moderate pain on the VAS scale = 31-54 mm)
排除标准
- •Concomitant rheumatic systemic pathologies.
- •History of trauma or recent surgical intervention in the head, face, neck or chest.
- •Presence of intraoral infections or odontogenic pain.
- •Headache of neuropathic origin (trigeminal neuralgia, Arnold neuralgia, etc.).
- •Being receiving therapy (except rescue pharmacological therapy) for this disorder or pain.
- •Cognitive impairment that prevents the follow-up of an educational program (determined through the MoCA questionnaire)
研究组 & 干预措施
Self-management Group
This group will implement a protocol based on self-management consisting of 5 levels of strategy: educational concepts and dynamics, cognitive behavioural tools, therapeutic exercise of the orofacial region, guidelines and strategies for lifestyle modification and mindbody tools. This protocol was developed by conducting a previous Scoping Review abouts application methods of selfmanagement in orofacial region. The intervention will be carried out in 5 total sessions of 45-60 minutos over 10 weeks.
干预措施: Self-management intervention (Other)
Clinical Practice Guideline Group
The protocol will be based on the Clinical Practice Guideline for the Management of Temporomandibular Disorders 2021. Following the guideline, there will be 5 sessions of pathology and pain education, cognitive behavioural tools for bruxism and parafunctional habits, jaw exercises for motor control, mobility and strength, and manual therapy. The intervention will be carried out in 5 total sessions of 45-60 minutos over 10 weeks.
干预措施: Clinical Practice Guideline Intervention (Other)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: It will be used in the pre-intervention, post-5 weeks and post-6 months analyses.
Pain intensity assessment instrument consisting of a 10-centimetre horizontal line numbered from 0 to 10, where 0 represents no pain and 10 represents the greatest unimaginable pain. The patient must mark on the line the point that indicates the intensity of his or her pain and then it is measured with a millimetre ruler. The intensity is expressed in centimetres or millimetres. If reporting a score on this scale, it is important to include the minimum and maximum values (0 and 10, respectively), as well as clarify that higher scores represent worse pain intensity. This tool has a high reliability, with an Internal Consistency (IC) of 0.97.
Chronic Pain Grading Scale 2.0 Spanish Version (GCPS)
时间窗: It will be used in the pre-intervention, post-5 weeks and post-6 months analyses.
Quantitative assessment scale of chronic pain that evaluates the degree of pain using 8 items, quantifying the number of days of pain in the last 6 months, current pain, average and maximum monthly pain and pain and limitation in ADL, social and occupational activities. Each item measures the score on an 11-point Likert scale, with a total range from 0 to 70 points. The tool has an internal consistency, represented by Cronbach's α coefficient, of 0.87 (95% CI, 0.83-0.92). If reporting a score on this scale, it is important to include the minimum and maximum values (0 and 70, respectively), as well as clarify that higher scores represent worse outcomes.
次要结局
- Pain Locus of Control Questionnaire (CLCD)(It will be used in the pre-intervention, post-5 weeks and post-6 months analyses.)
- Pressure Algometry(It will be used in the pre-intervention, post-5 weeks and post-6 months analyses)
- Demographic data(These data will be collected pre-intervention.)
- Pain Catastrophizing Scale (PCS)(It will be used in the pre-intervention, post-5 weeks and post-6 months analyses.)
- The Tampa Scale of Kinesiophobia for Temporomandibular Disorders Versión Español (TSK11-TMD-S)(It will be used in pre-intervention, post-5 weeks and post-6 months analyses.)
- Fear-Avoidance Beliefs Questionnaire (FABQ)(It will be used in the pre-intervention, post-5 weeks and post-6 months analyses.)
- The Mandibular Function Impairment Questionnaire (MFIQ)(It will be used in the pre-intervention, post-5 weeks and post-6 months analyses.)
- Máxima apertura de la boca (MMO)(It will be used in the pre-intervention, post-5 weeks and post-6 months analyses.)
- Intra-articular sounds(To be used in pre-intervention, post-5 weeks and post-6 months analyses.)
- Borg Scale(It will be collected during each of the exercise sessions to check compliance with the intensity of the exercises. The data will not be processed statistically.)
- Big Five Personality Test (BFQ)(This tool will be used in the pre-intervention measurement.)
- The SCL-90-R Symptom Inventory(It will be used in the pre-intervention analysis.)
- Brief Coping Coping with Stress Questionnaire (COPE28)(It will be used in the pre-intervention, post-5 weeks and post-6 months analyses.)
- The Perceived Stress Scale (PSS) questionnaire.(It will be used in the pre-intervention, post-5 weeks and post-6 months analyses.)
- The Strait Anxiety Questionnaire (STAI)(It will be used in the pre-intervention, post-5 weeks and post-6 months analyses.)