Efficacy of Therapeutic Exercise and Pain Neurophysiology Education in Temporomandibular Disorders
- Conditions
- Temporomandibular Disorder
- Interventions
- Behavioral: Therapeutic ExerciseBehavioral: Pain Neurophysiology Education
- Registration Number
- NCT06502769
- Lead Sponsor
- University of Alcala
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 36
- Over 18 years of age
- Limitation of mouth opening and/or jaw pain lasting more than 6 months
- Being able to understand the objective and carry out the study procedures
- Sign the informed consent.
- Suffer from any underlying disease
- Pain due to tumors or infections, metastases, osteoporosis, inflammatory arthritis or fractures
- Be receiving any other treatment for TMD or consuming some type of substance that alters muscle tone.
- Patients with myopathies, diseases of the Peripheral Nervous System, mental disorders diagnosed by a doctor
- Inability to collaborate
- Any other situation in which the evaluation could be altered.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TE group Therapeutic Exercise patients with TMD who are going to perform isolated therapeutic exercise TE+PNE group Therapeutic Exercise patients with TMD who are going to combine therapeutic exercise with education in pain neurophysiology TE+PNE group Pain Neurophysiology Education patients with TMD who are going to combine therapeutic exercise with education in pain neurophysiology
- Primary Outcome Measures
Name Time Method Pain intensity The scale will be passed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment. 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".
- Secondary Outcome Measures
Name Time Method Self-Perception of Improvement at baseline, immediately after treatment, 4 and 12 weeks after treatment. PGIC will be used to assess perceived improvement after treatment (range, 0-7). Higher scores will indicate greater improvement
Mouth opening without pain at baseline, immediately after treatment, 4 and 12 weeks after treatment. The distance between the upper and lower mandibular central incisors will be measured using a TheraBite range of motion scale.
Orofacial disability and pain at baseline, immediately after treatment, 4 and 12 weeks after treatment. 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.
Kinesiophobia at baseline, immediately after treatment, 4 and 12 weeks after treatment. 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
Pressure pain thresholds at baseline, immediately after treatment, 4 and 12 weeks after treatment. 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.
Catastrophism at baseline, immediately after treatment, 4 and 12 weeks after treatment. 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
Trial Locations
- Locations (1)
Campus Científico Tecnológico UAH. AV. de León, 3A.
🇪🇸Alcalá de Henares, Madrid, Spain