Pain Neuroscience Education, Motor Imagery and Action Observation in Patients With Chronic Temporomandibular Disorders.

NCT05003349 | Completed

• 1 other identifier: PNE, MI and AO in TMD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

TMD

Keywords

Pain Neuroscience Education; Motor Imagery; Action Observation; Exercises; Occlusal Splint

Outcome Measures

Primary Outcomes (2)

• Change in Pain intensity.

  The Numerical Pain Rating Scale (NPRS) will be used to assess pain intensity. This scale consists in a sequence of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable".

  At baseline, then at six, twelve weeks, and 3 months follow-up.

• Change in Craneofacial pain and disability inventory.

  The Craneofacial pain and disability inventory (CF-PDI) is a self-administered questionnaire that has been designed to obtain information on how pain in the orofacial region affects the patient's daily life. It consists of 21 items, with the final score ranging from 0 to 63 points. Each question is scored on a 4-point ordinal scale, ranging from 0 to 3. A higher score reflects higher pain and disability levels.

  At baseline, then at six, twelve weeks, and 3 months follow-up.

Secondary Outcomes (7)

• Change in Pressure Pain Threshold.

  At baseline, then at six, twelve weeks, and 3 months follow-up

• Change in Temporal Summation.

  At baseline, then at six, twelve weeks, and 3 months follow-up

• Change in Conditioned Pain Modulation.

  At baseline, then at six, twelve weeks, and 3 months follow-up

• Change in Central Sensibilization Inventory.

  At baseline, then at six, twelve weeks, and 3 months follow-up

• Change in Pain Catastrophizing Scale

  At baseline, then at six, twelve weeks, and 3 months follow-up

Study Arms (2)

Experimental group

EXPERIMENTAL

Occlusal Splint (OS) + Pain Neuroscience Education (PNE) + Motor Imagery (MI) + Action Observation (AO) + Jaw and Neck Exercises (JNE) All participants in this arm will receive OS (they must use every night during the study) and will receive physiotherapy treatment including PNE, MI, AO and JNE, in 2 sessions per week, each lasting 60 minutes, during 5 weeks. For PNE a power-point presentation with metaphors, images and videos will be employed. For the MI, the participants will be asked to judge the laterality of different cervical images presented on the screen of a cell phone. The laterality task will be executed using an application called Recognize Neck, developed by the NOI group. The AO will be carried out using videos of mandibular and cervical exercises. The JNE program will be performed 3 sets of 10 repetitions. The exercises will be executed with a total time per session of 20 minutes, initially at the clinic and later at home.

Other: Occlusal Splint (OS).; Other: Pain Neuroscience Education (PNE).; Other: Motor Imagery (MI).; Other: Action Observation (AO).; Other: Jaw and Neck Exercises (JNE)

Active comparator

ACTIVE COMPARATOR

Occlusal Splint (OS) + Counselling + Jaw and Neck Exercises (JNE). All participants in this arm will receive OS and will receive physiotherapy treatment including Counselling and JNE, in 2 sessions per week, each lasting 40 minutes, during 5 weeks. The JNE will be administered in the same way as in the other arm of the study. Counselling include education about the anatomical, biomechanical and psychosocial factors relationed with temporomandibular disorders, guidance regarding the parafunction jaw activities for eg will be taught the resting postural position of the mandible (teeth apart, lips slightly touching and tongue not pushing against the teeth).

Other: Occlusal Splint (OS).; Other: Jaw and Neck Exercises (JNE); Other: Counselling.

Interventions

Occlusal Splint (OS). OTHER

OS will be made of heat-cured acrylic by the same specialized dentist. These intraoral devices will be flate, rigid, will cover the entire dental arch, and will have the lowest possible height. The perimeter of the splint will have at least 11 dental contacts, light, symmetrical and pinpoint as possible. The patients will be instructed to use the splint every night during the study Two supervisions will be carried out 30 and 60 days after the use of the OS, in order to stabilize the contact points.

Active comparator; Experimental group

Pain Neuroscience Education (PNE). OTHER

A power point presentation with metaphors and animated videos will be used. The PNE will be held in 10 sessions of 20 minutes each. The intervention will be developed using content according to the book "Explain Pain" and the web page www.retrainpain.org.

Experimental group

Motor Imagery (MI). OTHER

The participants will have to judge the laterality of different cervical images presented on the screen of a cell phone. The laterality task will be executed using an application called Recognize Neck, developed by the NOI group. The procedure will begin with a familiarization test with the "Basic" level followed by a laterality discrimination task. It will be performed using 20 images, with 5 seconds for each image, beginning with the "Vanilla" program and progressively increasing the difficulty using the "Context" and "Abstract" programs. The estimated time to complete the task will be about 10 minutes per session.

Experimental group

Counselling. OTHER

Counselling include education about the anatomical, biomechanical and psychosocial factors relationed with temporomandibular disorders, guidance regarding the parafunction jaw activities for eg will be taught the resting postural position of the mandible (teeth apart, lips slightly touching and tongue not pushing against the teeth).

Active comparator

Action Observation (AO). OTHER

The patients will see videos showing the jaw and cervical exercises with the same series and repetitions that they will actively perform in the session. Therefore, the training of the action observation will be carried out dynamically. The patient will be asked to think and visualize the movement that he/she will have to perform later. It is estimated 10 minutes per session for the AO.

Experimental group

Jaw and Neck Exercises (JNE) OTHER

A jaw and neck exercise program will be carried out in 3 series of 10 repetitions per session will be planned with 1minute rest between exercise. The exercises will be executed with a total time per session of 20 minutes, initially in the clinic and later at home. In the clinic, verbal and tactile instructions will be provided for the correct execution of the exercises and later they will be sent through WhatsApp and / or mail to perform them at home.

Active comparator; Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Gran Rosario: lead

Study Sites (1)

University of Gran Rosario

Rosario, Santa Fe Province, 2000, Argentina

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Occlusal Splints; Counseling

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 12, 2021
• Study Start: August 31, 2021
• Primary Completion: November 30, 2025
• Study Completion: January 12, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)