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.
The patient presents TMDs diagnosed according to the CD/TMD classification.
Age between 18 and 65.
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.
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.).
Parallel
Self-management intervention
Other interventionThis intervention will implement a self-management protocol. It will consist in 5 strategy levels: educational concepts and dynamics, cognitive behavioural tools and processes, therapeutic exercise of the orofacial region, guidelines and strategies for lifestyle modification and mindbody tools. Several of the above 5 strategies will be employed in each session. Education will include TMD concepts, pain neurophysiology, contextualisation of pain in terms of perceived stress, anxiety and others. Exercises will aim to train motor control, strength and mobility. Cognitive behavioural tools will be used to modulate pain relationship through behaviour modification. Processes such as cognitive distraction, gradual exposure to movement or the scheduling of self-care activities will be used. Mindbody strategies such as relaxation exercises and pain acceptance will seek to reduce the patient's frustration with pain. Structured guidelines will be included to achieve desirable lifestyle changes.
Clinical Practice Guideline Intervention
Other interventionFollowing the guidelines, 5 sessions of education, cognitive behavioural tools, jaw exercises and manual therapy will be conducted. The educational sessions will teach about TMD and basic pain concepts. A single type of cognitive behavioural tool will be employed. The aim will be to decrease bruxing and parafunctional activity during wakefulness. This will be done by training the jaw relaxation position, which will then be generalised to activities of daily living with the help of some conditioning through positive and negative reinforcement. Exercise activities will aim to train motor control, strength and mobility. Manual therapy will be carried out in the orofacial region by means of soft tissue techniques and joint mobilisation.
Visual Analogue Scale (VAS)
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)
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.
Demographic data
A standardised questionnaire will be used to collect information on age, sex, profession, concomitant conditions, drugs used (number, name and category).
Pain Catastrophizing Scale (PCS)
A scale that assesses catastrophic thoughts, consisting of 3 dimensions: rumination (constant worry and inability to inhibit pain-related thoughts), magnification (exaggeration of the unpleasantness of pain situations and expectations of negative consequences) and helplessness (inability to cope with painful situations). It consists of 13 items with a five-point Likert-type response scale (0 = Not at all; 4 = All the time), with scores ranging from 0 to 52. High scores indicate a greater presence of catastrophic thoughts. This tool has an internal consistency (Cronbach's α) of 61.8%-\>70%.
The Tampa Scale of Kinesiophobia for Temporomandibular Disorders Versión Español (TSK11-TMD-S)
Scale assessing kinesiophobia or fear of movement or injury in patients with TMD. The scale consists of a total of 11 items. In each of the items, the user must indicate his or her degree of agreement with each of the statements presented. In this way, it is scored using a Likert-type scale from 1 (totally disagree) to 4 (totally agree), with higher scores being indicators of greater fear of movement. It has an Internal Consistency (Cronbach's α) of 0.843.
Fear-Avoidance Beliefs Questionnaire (FABQ)
It is a self-administered questionnaire that assesses the patient's fear-avoidance beliefs about physical activity and work. It assesses activities of daily living, behaviour, functional mobility, general health, participation, mental health, motivation, occupational performance, pain, personality, quality of life, self-efficacy, stress and coping. It consists of 16 items in which the patient scores his or her degree of agreement or disagreement with the statement proposed in each item, using a 7-point Linkert-type scale. Where 0 symbolises complete disagreement and 6 complete agreement. The maximum score that can be obtained is 96 points, with higher scores indicating higher fear-avoidance beliefs. It consists of two subscales: the work subscale (FABQw) with 7 questions and a maximum score of 42 points, and the physical activity subscale (FABQpa) with 4 questions and a maximum score of 24. ICC=0.97,FABQpa CI=0.77,FABQw=0.88. The total maximum score that can be obtained is 96 points
Treatment adherence
Defined by the WHO as 'the degree to which a patient's behaviour, in relation to taking medication, following a diet or modifying lifestyle habits, corresponds to the recommendations agreed with the health professional'. Participants will be given a diary-like notebook to fill in with the activities carried out on a weekly basis. This method of recording adherence to therapeutic exercise has been used previously in other studies. Each patient will be warned that failure to complete a minimum number of activities (70%) will result in exclusion from the study.
Montreal Cognitive Assessment Test (MoCA Test)
A brief screening test for the identification of mild cognitive impairment and early dementia processes. The total score of the MoCA test is 30 points, and the administration time is 7-10 ms. It is validated in the Spanish population between 18 and 90 years of age. It assesses the general cognitive status of the individual through different cognitive domains. Total score: The maximum score is 30 points, and the minimum score is 0 points. A higher score indicates better cognitive functioning, while a lower score suggests a higher likelihood of cognitive impairment. Typically, a score below 26 points may indicate possible cognitive impairment, though interpretation should consider other factors such as education level and clinical context.
Self-reporting of educational level
The educational level was obtained through the question 'What is the highest level of education you have completed?', where 8 options could be selected (1. primary education or lower, 2. secondary education, 3. baccalaureate, 4. vocational training, 5. degree studies).
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