Efficacy of Therapeutic Exercise and Pain Neurophysiology Education in Temporomandibular Disorders
NCT Number: NCT06502769
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Temporomandibular Disorder
Interventions: BEHAVIORAL: Therapeutic Exercise|BEHAVIORAL: Pain Neurophysiology Education
Sponsor: University of Alcala
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-09-30
Locations: Campus Científico Tecnológico UAH. AV. de León, 3A., Alcalá de Henares, Madrid, 28804, Spain

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.

Primary Outcome Measures: 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"., The scale will be passed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment.
Secondary Outcome Measures: Mouth opening without pain, The distance between the upper and lower mandibular central incisors will be measured using a TheraBite range of motion scale., 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., 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, 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, at baseline, immediately after treatment, 4 and 12 weeks after treatment.|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., 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, at baseline, immediately after treatment, 4 and 12 weeks after treatment.