The aim of this study is to compare the effects in pain of two different treatments in pacients with temporomandibular disorders (TMD). One group will receive isolated therapeutic exercise (TE) and the other will receive TE combined with pain neurophysiology education (PNE). The hypothesis of this study is that the PNE+TE group will obtain superior therapeutic results than an isolated TE program.
Objective: To evaluate the differences in pain intensity by performing isolated therapeutic exercise (TE) versus performing the same exercise combined with pain neurophysiology education (PNE) in patients with temporomandibular disorders (TMD). Design: Single-blind randomized controlled trial. Setting: Faculty of Physical Therapy of Alcalá de Henares. Participants: Subjects with TMD lasting more than 6 months (N= 36). Interventions: Participants will be randomly assigned to receive a TE program consisting of stretching, coordination and strengthening exercises (n= 18) or the same TE program in addition to a PNE program (n= 18), performed in two sessions of 40 minutes in groups of 6 participants. The intervention will last 12 weeks, where all participants must complete the exercise program daily, one year later they will be evaluated again. Main outcome measures: The primary outcome will be pain intensity through the visual analogue scale (VAS) which will be completed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment. Secondary outcome measures include pain-free mouth opening, Craniofacial Pain and Disability Inventory (CF-PDI), Pain Catastrophizing Scale (PCS), Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-11), pressure pain thresholds (PPT) and Patient Global Impression of Change (PGIC). They will be recorded through blinded assessments performed by 2 physiotherapists at baseline, immediately after treatment, 4 and 12 weeks after treatment. Student's t test will be used to determine differences between group interventions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
A therapeutic exercise program will be carried out
A PNE program will be carried out
Campus Científico Tecnológico UAH. AV. de León, 3A.
Alcalá de Henares, Madrid, Spain
Pain intensity
The intensity of pain will be evaluated using the Visual Analogue Scale that is represented by a 10cm line where the left end indicates "no pain" and the right end indicates "maximum pain".
Time frame: The scale will be passed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment.
Mouth opening without pain
The distance between the upper and lower mandibular central incisors will be measured using a TheraBite range of motion scale.
Time frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Orofacial disability and pain
The CF-PDI is a self-administered questionnaire that measures pain and disability outcomes related to craniofacial pain. It consists of 21 items, with a score ranging from 0 to 63 points. A higher score reflects higher levels of disability.
Time frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Catastrophism
The PCS consists of a self-administered questionnaire with 13 items for the evaluation of catastrophic thoughts. It is divided into three domains: helplessness, magnification and rumination. Higher values denote greater pain catastrophizing
Time frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Kinesiophobia
The Spanish version of the TSK-11 will be used to evaluate the fear of re-injury due to movement. This questionnaire has a structure of 11 items and 2 factors that includes avoidance and harm of activities. Higher scores reflect greater fear of movement
Time frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
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Pressure pain thresholds
The masseter and anterior temporal PPTs will be assessed bilaterally using an analog algometer. Measurements will be reported in kg/cm2. The points will always be evaluated in the same order and will be repeated three times, with an interval of 1 minute. For each point the average of the three measurements will be considered.
Time frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Self-Perception of Improvement
PGIC will be used to assess perceived improvement after treatment (range, 0-7). Higher scores will indicate greater improvement
Time frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.