---
title: Pain Neuroscience Education, Motor Imagery and Action Observation in Patients With Chronic Temporomandibular Disorders.
nct_id: NCT05003349
overall_status: COMPLETED
phase: NA
sponsor: University of Gran Rosario
study_type: INTERVENTIONAL
primary_condition: TMD
countries: Argentina
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05003349.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05003349"
ct_last_update_post_date: 2026-01-15
last_seen_at: "2026-05-12T06:43:31.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT05003349](https://clinicaltrials.gov/study/NCT05003349)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** University of Gran Rosario
- **Conditions:** TMD
- **Start Date:** 2021-08-31
- **Completion Date:** 2026-01-12
- **CT.gov Last Update:** 2026-01-15

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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.
- **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).

## 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.
- **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.
- **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.
- **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.
- **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.
- **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).

## Primary Outcomes

- **Change in Pain intensity.** _(time frame: At baseline, then at six, twelve weeks, and 3 months follow-up.)_ — 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".
- **Change in Craneofacial pain and disability inventory.** _(time frame: At baseline, then at six, twelve weeks, and 3 months follow-up.)_ — 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.

## Secondary Outcomes

- **Change in Pressure Pain Threshold.** _(time frame: At baseline, then at six, twelve weeks, and 3 months follow-up)_
- **Change in Temporal Summation.** _(time frame: At baseline, then at six, twelve weeks, and 3 months follow-up)_
- **Change in Conditioned Pain Modulation.** _(time frame: At baseline, then at six, twelve weeks, and 3 months follow-up)_
- **Change in Central Sensibilization Inventory.** _(time frame: At baseline, then at six, twelve weeks, and 3 months follow-up)_
- **Change in Pain Catastrophizing Scale** _(time frame: At baseline, then at six, twelve weeks, and 3 months follow-up)_
- **Change in Spanish version of the Tampa Scale of Kinesiophobia for Temporomandibular. Disorders** _(time frame: At baseline, then at six, twelve weeks, and 3 months follow-up)_
- **Change in Home exercise adherence** _(time frame: Between the sixth and twelfth week (once per week))_

## Locations (1)

- University of Gran Rosario, Rosario, Santa Fe Province, Argentina

## Recent Field Changes (last 30 days)

- `eligibility.minAge` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of gran rosario|rosario|santa fe province|argentina` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT05003349*  
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