Clinical trial NCT05003349: Pain Neuroscience Education, Motor Imagery and Action Observation in Patients With Chronic Temporomandibular Disorders.
Official title: Additional Effect of Pain Neuroscience Education, Motor Imagery and Action Observation in Patients With Chronic Temporomandibular Disorders. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: TMD
Keywords: Pain Neuroscience Education
Motor Imagery
Action Observation
Exercises
Occlusal Splint
Lead sponsor: University of Gran Rosario
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study will be to verify the additional effect of Pain Neuroscience Education, Motor Imagery and Action Observation on primary outcomes pain intensity and craniofacial pain and disability in patients with chronic temporomandibular disorders (TMD). The secondary outcomes will be pressure pain threshold, temporal summation, conditioned pain modulation, central sensibilization, pain catastrophizing, kinesiophobia. This study will be a doble-blinded randomized clinical trial comprising a sample of 50 participants with orofacial pain of both genders and aged between 18 and 60 years. Subjects will undergo a screening process to identify those presenting a diagnosis of painful TMD confirmed by the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), and then they will be randomized into two groups (G1: Occlusal Splint, Counselling and Jaw and Neck Exercises vs. (G2: Occlusal Splint, Jaw and Neck Exercises plus Pain Neuroscience Education, Motor Imagery and Action Observation). These volunteers will be recruited from the Alisos Group Dentistry Clinic and University of Gran Rosario, (Rosario, Argentina). All patients will wear an occlusal splint designed by dentists. The interventions will be administered twice a week for 5 weeks by a single therapist. Subsequently, patients will be given instructions to perform the exercises at home for 5 weeks. Primary and secondary outcomes will be measured at baseline, 6 weeks and 12 weeks, and at 3 months after the end of treatment (follow-up). All the evaluations will be performed by a blinded physiotherapist.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of painful TMD using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
* A history of orofacial pain during at least three months prior to the study
* Age ranging between 18 to 65 years, both genders.

Exclusion Criteria:

• Patients with neurological disorders (neuropathic pain or neurodegenerative disease), whiplash associated disorders, specific neck pain (radicular pain), recent dental or physical therapy. If patients are taking medication to relieve pain during the study, they will be encouraged to report it.

Primary outcomes:
measure: Change in Pain intensity.
timeFrame: At baseline, then at six, twelve weeks, and 3 months follow-up.
measure: Change in Craneofacial pain and disability inventory.
timeFrame: At baseline, then at six, twelve weeks, and 3 months follow-up.
Secondary outcomes:
measure: Change in Pressure Pain Threshold.
timeFrame: At baseline, then at six, twelve weeks, and 3 months follow-up
measure: Change in Temporal Summation.
timeFrame: At baseline, then at six, twelve weeks, and 3 months follow-up
measure: Change in Conditioned Pain Modulation.
timeFrame: At baseline, then at six, twelve weeks, and 3 months follow-up
measure: Change in Central Sensibilization Inventory.
timeFrame: At baseline, then at six, twelve weeks, and 3 months follow-up
measure: Change in Pain Catastrophizing Scale
timeFrame: At baseline, then at six, twelve weeks, and 3 months follow-up
measure: Change in Spanish version of the Tampa Scale of Kinesiophobia for Temporomandibular. Disorders
timeFrame: At baseline, then at six, twelve weeks, and 3 months follow-up
measure: Change in Home exercise adherence
timeFrame: Between the sixth and twelfth week (once per week)
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: University of Gran Rosario
state: Santa Fe
Study officials:
References: