Temporomandibular Joint Disorders Clinical Trial
Official title:
Immediate Effects of the Mandibular Muscle Energy Technique in Patients With Mandibular Joint Pathology and Bruxism. Randomized Controlled Clinical Trial
This is a randomized, controlled, double-blind clinical trial. The main objective is to evaluate the immediate effect of the mandibular muscle-energy technique on pain, functionality and kinesiophobia in subjects suffering from temporomandibular dysfunction and bruxism. In the experimental group the jaw muscle-energy technique will be applied and in the control group a placebo technique will be applied. The intention is to see the immediate effects of the intervention and two evaluations of the pre- and post-intervention outcome variables and a follow-up of kinesiophobia one week later will be performed.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 23, 2023 |
Est. primary completion date | June 23, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patients who agree to participate in the study by signing the informed consent form. - Patients attending maxillofacial consultation with pain, temporomandibular dysfunction and bruxism. - Pain of at least 3 months of evolution. Exclusion Criteria: - Patients with congenital malformations or cervical spine pathology. - Infectious or inflammatory disease in its acute phase. - Patients with vertigo or vestibular alterations. - If there is a contraindication to the technique or phobia on the part of the patient. - Physiotherapy treatment (manual therapy or electrotherapy) in the last month before their incorporation in the study. - Pharmacological treatment (analgesics, relaxants and anti-inflammatory drugs) in the last 24 hours before the initial evaluation. |
Country | Name | City | State |
---|---|---|---|
Spain | University of Salamanca | Salamanca |
Lead Sponsor | Collaborator |
---|---|
University of Salamanca | Instituto de Investigación Biomédica de Salamanca |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in craniofacial pain intensity | For the subjective evaluation of craniofacial pain, the visual analog scale (VAS) will be applied. Scale from 0 (no pain at all) to 10 (maximum possible pain). | 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group. | |
Secondary | Changes in mouth opening mobility | The active opening of the mouth will be measured using a digital caliper | 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group. | |
Secondary | Changes in rightward mandibular translation | The active rightward mandibular translation will be measured using a digital caliper | 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group. | |
Secondary | Changes in leftward mandibular translation | The active leftward mandibular translation will be measured using a digital caliper | 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group. | |
Secondary | Changes in Pressure pain threshold at myofascial trigger point (PT1) of the both upper trapezius muscles | The pressure threshold will be recorded using a digital algometer | 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group. | |
Secondary | Changes in pressure pain threshold at myofascial trigger point of the both external pterygoid muscles | The pressure threshold will be recorded using a digital algometer | 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group. | |
Secondary | Changes in pressure pain threshold at myofascial trigger point of the both digastric muscles | The pressure threshold will be recorded using a digital algometer | 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group. | |
Secondary | Changes in kinesiophobia | The Kinesiophobia will be recorded using the spanish version of the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD-S). It is a valid and reliable instrument for measuring kinesiophobia in patients with TMD, and it uses a Likert scale (1-4) containing 11 items in 2 domains, with higher scores indicating higher levels of kinesiophobia (0-44). | 2 evaluations, one pre-intervention and one post-intervention, 5 minutes after the end of the intervention according to the assigned group. And a follow-up after one week |
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