Therapeutic exercises, manual therapy, and health education program for adolescents with temporomandibular disorders: face-to-face and online multimodal rehabilitation protocol for a randomized controlled clinical trial | Trials

Explanation for the choice of comparators {6b}

The chosen comparison variables were pain, ROM function, and main points of physiotherapeutic treatment, with the variable peripheral muscle oxygenation, a distinguishing feature of this study.

Intervention description {11a}

After the initial evaluations, randomization will be performed for the distribution of individuals in the following groups: (1) face-to-face group (GF) and (2) telerehabilitation group (GT).

Initially, an evaluator will categorize participants into the eligibility criteria by collecting information related to personal data, mass, height, body mass index, medical history, previous illnesses, concomitant illnesses, use of interocclusal devices, medications, previous surgeries, physiotherapy, and other aspects.

After screening, acceptance, and signing of ethical terms, anamnesis will begin with participant identification data, demographics, anthropometric assessment, and assessment using the DC/TMD to confirm the diagnosis.

This multimodal rehabilitation protocol used guidance resources, manual therapy, and exercises, and are in Table 1, which were considered low-cost resources based on the literature. We sought to simplify them to allow self-management.

The protocol will be applied online and in-person. The choice of 3 sessions was based on the satisfactory results of recent RCTs, which carried out a few (2 to 5) physiotherapy sessions in the treatment of musculoskeletal disorders of the head and neck region [18, 33].

Treatment interventions were standardized to improve the internal validity of the design and allow for ease of replication in future clinical trials or by professionals in their work environments. The GT intervention will take place synchronously remotely via video call via WhatsApp® and as can be seen in Table 1, the GT protocol will be similar to the GF, except for two basic differences in manual therapy and articular manipulation.

Counseling

The guidelines in this protocol include care, advice, pain education, and stress management strategies, which will be clarified at the beginning of each session, so that participants can learn and incorporate them into their daily lives. This promotion of autonomy for the patient [6] and their responsibility towards the treatment, promotes a more powerful result with a change in the general perception of pain and a reduction in recurrences [25]. To make it easier for participants and examiners to remember each orientation, the author created the acronym “TEPEDI,” which refers to the initials of thermotherapy, exercises, posture, explanation, lying down, and the importance of quality of life.

“T” for thermotherapy, which can be carried out at home with a cold or heat pack, to reduce pain or relax muscles [9]. “E” home exercises, which must be repeated every day, as taught in the sessions [43] and verified for their correct and satisfactory execution [9]. The GF and GT participants will be instructed to repeat the exercises, self-massage, and all instructions at home daily. “P” for correct posture in resting the tongue, jaw, head, and shoulders,the tongue should be on the hard palate and the jaw relaxed [26], the head aligned with the dorsal column with the shoulders lowered [26]. “E” for explanation, the patient who receives an explanation and understands the use of TMJ and the precipitating and predisposing factors of TMD, may have a better prognosis and adherence to treatment [25]. “D” for decreased parafunction and unclenched teeth from contact, in order to manage parafunctional habits, which can be remembered and made aware through post-it notes or through the “Desencoste” app. Participants will be informed that when the jaw is at rest, their teeth should not touch, except when swallowing or eating [7, 9]. “I” to remember the importance of basic habits in the quality of life, such as sleep hygiene [34], the practice of physical activity [28], and relaxation. This relaxation can be done in several ways and in this protocol, diaphragmatic breathing was used, with re-education of the breathing pattern, stimulation of the diaphragm, and relaxation of the accessory respiratory muscles [41].

Manual therapy

The manual approaches to this protocol include passive myofascial release (in GF) or self-massage (in GT), and it is demonstrated in Fig. 1, with guidance that this pressure is gentle and comfortable manner depending on individual tolerance. A previous study [12] showed that myofascial release applied for 10 min to the trapezius muscle was effective in the hemodynamic variable of the total saturation index (TSI), which reinforces the choice of technique and application time chosen in this RCT. The participants in both groups will still be instructed to add self-massage to their daily self-care tasks. To facilitate the checklist for each region to apply MT, the acronym “MAN” was created, which refers to the initials of the regions: masticatory muscles, articulation TMJ, and neck.

Masticatory muscles: Manual therapy of the masticatory muscles in the intraoral and extraoral regions [3]. It will be performed in the GF and GT groups. In the IO maneuver, the patient will be instructed to place the contralateral thumb on the mandible that will receive the maneuver, and the other fingers must rest on the external region of this cheek. Attention will be placed on some details upon carrying out the maneuver, including the use of gloves in the GF, hygiene of hands, and whether the patient is free from internal injuries or limitations that cause discomfort.

TMJ: Non-specific joint mobilization of the TMJ, with rhythmic, oscillatory movement, in the posteroanterior direction, for 1 min 30 s, 3 to 5 times, with an interval of 30 s between series [9]. This maneuver will only be performed in the GF.

Neck muscles: Manual therapy in the posterior and anterior region of the muscles neck (scalene, sternocleidomastoid, trapezius, elevator scapula, suboccipital, supra, and infrahyoid muscles) [41]. This maneuver will be performed in both groups.

Therapeutic exercises

Patients will be informed of the objective of each exercise, the need to communicate in the event of pain, caution in each performance, and pauses to avoid muscle fatigue [24]. The regions that will receive the exercises will be the same as those of the TM,therefore, the same acronym “MAN” was used for the checklist of the “masticatory” muscles, TMJ “articulation”, and “neck” muscles. The use of a mirror will be recommended in favor of awareness in movement, correcting deviations, and excessive amplitude, minimizing joint noises; thus, which facilitates learning, since the exercises will be advised to be repeated at home every day [8]. A 30-s rest interval will be recommended between each exercise. The exercises aim to achieve muscle relaxation and optimize function.

The jaw exercises will be isotonic and isometric and are demonstrated in Fig. 2: isotonic exercises in a free and maximum range of motion for all mandibular ranges (lateralization, opening, closing, protrusion, with 6 repetitions of each movement) [8, 22]. Strengthening isometrics, with small resistance given by the fingers, and tongue on the palate, for all mandibular ranges (lateralization, opening, closing, protrusion, with 6 repetitions of each movement) [8, 9, 22, 41].

The TMJ exercise chosen was the “N position” with opening and protrusion of the mouth with the tongue on the palate (3 sets of 10 repetitions, 30-s intervals) [8, 9, 13, 24, 32].

The exercises for the neck region are demonstrated in Fig. 3, and it will be as follows: stretching in all planes of movement (extension, flexion, rotation and inclination right and left, inclination with flexion, six repetitions of each movement), self-growth exercise correcting posture and seeking alignment (for 1 min) [21, 41] and an anterior skull rotation exercise by nodding the head (six times out of six repetitions) [32].

Criteria for discontinuing interventions {11b}

The criteria for halting interventions for a trial participant encompass adolescents who request a temporary suspension for personal reasons or whose deteriorating condition prompts them to withdraw from active participation.

Strategies to improve adherence to interventions {11c}

Two clinics will be available, in different locations, in the city of Florianópolis (Brazil), in order to facilitate movement and improve participant adherence. In-person assessments and consultations take place in these clinics according to the participant’s choice. In addition, there will be flexibility in scheduling times, and patients will receive reminders and videos of exercises and care at home.

Relevant concomitant care permitted or prohibited during the trial {11d}

During this training, adolescents will not be able to undergo other treatments such as the use of an interocclusal splint, medications, or other physiotherapy services, other than those offered in this protocol, nor will they be able to start using orthodontic appliances.

Provisions for post-trial care {30}

As a form of care post-trial, all participants will receive a report with the results of the instruments used, as well as care guidelines and home exercises.

Outcomes {12}

Each group will undergo an initial assessment (T0), followed by three treatment sessions: an immediate reassessment (which will be carried out 0–2 days after the third session [T1]), another reassessment 30 days after the end of treatment, and treatment follow-up (T2). Assessments and reassessments will be performed in-person.

In addition to the physical aspects of DC/TMD and anthropometric assessment through mass and height measurements, the following instruments will be used: digital pressure algometer, graduated chronic pain scale (GCPS), pain drawing for pain assessment, infrared spectroscopy (NIRS) to assess peripheral muscle oxygenation, Tam scale (TSK/TMD) to assess kinesiophobia, and other psychosocial scales of DC/TMD, such as Generalized Anxiety Disorder 7-item (GAD7), Patient Health Questionnaire-4 (PHQ4), Oral Behaviors Checklist (OBC), and Jaw Functional Limitation Scale-8 (JFLS8). The assessment will last an average of 60 min, and the treatment sessions will last 30 min [43], with 10 min of guidance, 10 min of manual therapy and relaxation, 10 min of specific exercises, and reassessments lasting 40 min. This 3-session protocol will occur weekly. In reassessments, the same assessment instruments will be applied, with the exception of the GAD7 and PHQ4, as these will only be used to characterize the sample. Finally, all participants will receive a report with the results of the instruments used, as well as care guidelines and home exercises.

Diagnostic criteria of temporomandibular disorders—axis 1—physical assessment

For the diagnosis of TMD and clinical evaluation of the TMJ, the validated Portuguese version of the DC/TMD will be used, which classifies between myalgia, arthralgia, headache attributed to TMD, disc displacement, degenerative joint disease, or subluxation. There may be more than one diagnosis for each participant. This stage lasts an average of 15 to 20 min and will follow the regulations of the Delphi study Axis 1 of the DC for adolescents [5, 35]. Range of motion (ROM) measurements will be taken with a digital universal caliper.

Diagnostic criteria of temporomandibular disorders—axis 2—psychosocial assessment and pain

Axis 2 of the DC/TMD allows for psychosocial assessment and determination of the consequences of pain. Some suggestions from the Delphi study [36] for adolescents will be used, such as the GCPS, Pain Drawing, JFLS8, and OBC scales. Even though some questionnaires may be self-administered [9], it was decided to have one examiner (examiner “A” or “B”) accompany each participant, in order to accommodate doubts, check and reduce biases.

Tampa scale for kinesiophobia for temporomandibular disorders

The Tampa Kinesiophobia Scale for TMD (TSK/TMD) is a self-administered questionnaire with 18 questions, translated and cross-culturally adapted, and is valid and reliable for assessing kinesiophobia in patients with TMD [1].

Near-infrared spectroscopy

To obtain hemodynamic variables with high resolution in real time, such as oxyhemoglobin (HbO2), deoxyhemoglobin (HHb), total hemoglobin (tHb), tissue saturation index (TSI), and the near-infrared spectroscopy (NIRS) (Portamon®, Artinis, Netherlands), with an acquisition frequency of 10 Hz, in a non-invasive evaluation phase that lasts 5 min will be used [45].

The chosen muscle, positioning, and method that will be used were based on an oximetry study in adolescents with TMD [31], which evaluated the masseter muscle bilaterally, as it is involved in chewing in TMDs.

Oxygenation will be measured at two time points: with the muscle at rest (jaw relaxed and teeth disengaged) for 60 s, during muscle contraction (in dental occlusion), followed by the maximum voluntary isometric contraction of the masseter muscle for 20 s, and at moments T0, T1, and T2 of the ECR protocol. The side to start measuring the device was chosen randomly. For the purpose of dental protection, to contract the masseter, a parafilm (Pechinery® Plastic Packaging, USA) folded 15 times to a size of 1.5 cm by 3.5 cm will be used, which will be positioned between the occlusal surfaces of the first and second upper and lower molars.

Pressure algometry

To evaluate the pressure pain threshold (PPT), a digital pressure algometer from the brand MedEOR® model SP Tech, will be used, which allows for real measurement of pain thresholds and tolerances by mechanical pressure. These are two measurable and useful neurophysiological methods for clinical practice, which assess pain in an objective manner (MedEOR® Medtech LTDA, Brazil, 2018).

The position the participant will adopt, as well as the handling of the algometer, was based on a previous study [19], which evaluated the masseter and temporalis muscles bilaterally. The side to start measuring the device was chosen randomly. Pressure was applied until the volunteer complained of pain, indicated by raising the arm, and the value was recorded on an algometer display (kg/cm²). The PPT was measured three times at each location, with an interval of 5 s between each measurement, and the average was used for statistical analysis. Table 2 summarizes the instruments used, their scores, evaluations, and their respective classifications.

The Clinical Relevance of this study is that a multimodal face-to-face and telerehabilitation protocol for adolescents with TMD will be presented, and this protocol could serve as a basis for future research in this area and it can be easily used for clinical practice.

Participant timeline {13}

The participant’s timeline can be observed through the flowchart in Fig. 4.

Sample size {14}

For the sample calculation, the G Power program version 3.1.7 was used based on oxyhemoglobin data in adolescents with TMD [31], which represents the same population of this trial, and also, the authors used the same NIRS equipment,thus, the physiological variable, peripheral muscle oxygenation, was chosen as the primary outcome to calculate the sample size. The final sample size was 26 adolescents, with a significance level of 5% and power of 80%, the same significance and values used by a previous study [14]. The 26 adolescents will be randomized into two groups with 13 participants in each group.

Recruitment {15}

Patients will be recruited from communities located in the metropolitan area of Florianopolis City, south of Brazil, by means of announcements, pamphlets, posters, emails, social media, and invitations through schools.