search
Back to results

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

Primary Purpose

TMD

Status
Recruiting
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Occlusal Splint (OS).
Pain Neuroscience Education (PNE).
Motor Imagery (MI).
Action Observation (AO).
Jaw and Neck Exercises (JNE)
Counselling.
Sponsored by
University of Gran Rosario
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TMD focused on measuring Pain Neuroscience Education, Motor Imagery, Action Observation, Exercises, Occlusal Splint

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Gran RosarioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Active comparator

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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".
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.

Secondary Outcome Measures

Change in Pressure Pain Threshold.
The Pressure Pain Threshold (PPT) will be measured through a pressure algometer in 3 different sites; 1) Anterior temporalis muscle, 2) upper trapezius muscle and 3) thenar eminence (non-dominant hand). At each site, 3 measurements will be made with an interval of 30 seconds, and the mean will be registered. To determine the PPT, the pressure will be increased at a rate of approximately 1 kg/second and patients will be asked to raise their arm the moment the pressure begins to change to a sensation of pain, at which point, the evaluator will stop pressing. PPT values will be expressed in kg/cm2.
Change in Temporal Summation.
Temporal Summation (TS) will be induced using a pressure algometer. For TS, 10 consecutive pressure pulses will be elicited using the PPT (obtained before). For each pulse of the TS procedure, the pressure will increase at a rate of 1 kg/second until the PPT is reached, where it will remain for one second before being released. The pressure pulses will be repeatedly performed with an interval between stimuli of one second. Participants will be instructed to assess the pain intensity of the first and tenth pressure pulses according to the NPRS. The TS score will be obtained by subtracting the first NPRS score from the last score. The higher the TS score, the more efficient nociceptive signaling for the brain.
Change in Conditioned Pain Modulation.
For the Conditioned Pain Modulation (CPM) a occlusion cuff will be used as a conditioning stimulus. The cuff will be inflated in the non-dominant arm at approximately 20 mm Hg/second until the subjects report experiencing pain at a value of 5/10 using the NPRS, when inflation will stop. Subjects will adapt to the stimulus for 30 seconds, and the first PPT measurement will be performed. Then, the cuff will then be deflated and 1 minute later the second PPT measurement will be taken.
Change in Central Sensibilization Inventory.
The Central Sensibilization Inventory (CSI) is a self-report outcome measure that consists of two parts. Part A consists of 25 statements where the participant must answer how often he/she experience each symptom. Individual items are scored from "0" (never) to "4" (always), resulting in a total score range for all 25 items from "0" to "100". Part B asks if the participant have been previously diagnosed by a doctor for some diseases (YES/NO). Part B of the CSI is for information only and is not qualified. A score of more than 40 indicates the presence of central sensitization.
Change in Pain Catastrophizing Scale
The Pain Catastrophizing scale (PCS) is a 13-items instrument that ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points being (0) not at all and, (4) all the time. A total score (ranging from 0 to 52) is obtained, along with three subscale scores that assess rumination, magnification, and helplessness. A higher total PCS score of 30 represents a clinically relevant level of catastrophizing.
Change in Spanish version of the Tampa Scale of Kinesiophobia for Temporomandibular. Disorders
The Spanish version of the Tampa Scale of Kinesiophobia for Temporomandibular Disorders (TSK-TMD-S) consists of 10 items formulated positively and distributed in 2 subscales as follows: (1) somatic approach (items 1, 2, 3, 4 and 10) and (2) avoidance of activities (items 5 to 9). The total score can range from 10 to 40 (somatic focus, 5-20; avoidance of activity, 5-20), with higher scores indicating an increased fear of jaw movement and re-injury. The cut-off point to consider kinesiophobia is 23 points.
Change in Home exercise adherence
To assess adherence to home exercise, a google form will be sent weekly to the volunteers. It will consist of questions related to the number of times patients performed the exercises during the week and to the difficulties they encountered. Adherence to exercises will be expressed as a percentage [(number of exercise sessions performed / number of exercise sessions prescribed) X100].

Full Information

First Posted
August 3, 2021
Last Updated
July 10, 2023
Sponsor
University of Gran Rosario
search

1. Study Identification

Unique Protocol Identification Number
NCT05003349
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2021 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Gran Rosario

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TMD
Keywords
Pain Neuroscience Education, Motor Imagery, Action Observation, Exercises, Occlusal Splint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Active comparator
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Occlusal Splint (OS).
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pain Neuroscience Education (PNE).
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Motor Imagery (MI).
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Action Observation (AO).
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Jaw and Neck Exercises (JNE)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Counselling.
Intervention Description
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 Outcome Measure Information:
Title
Change in Pain intensity.
Description
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".
Time Frame
At baseline, then at six, twelve weeks, and 3 months follow-up.
Title
Change in Craneofacial pain and disability inventory.
Description
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.
Time Frame
At baseline, then at six, twelve weeks, and 3 months follow-up.
Secondary Outcome Measure Information:
Title
Change in Pressure Pain Threshold.
Description
The Pressure Pain Threshold (PPT) will be measured through a pressure algometer in 3 different sites; 1) Anterior temporalis muscle, 2) upper trapezius muscle and 3) thenar eminence (non-dominant hand). At each site, 3 measurements will be made with an interval of 30 seconds, and the mean will be registered. To determine the PPT, the pressure will be increased at a rate of approximately 1 kg/second and patients will be asked to raise their arm the moment the pressure begins to change to a sensation of pain, at which point, the evaluator will stop pressing. PPT values will be expressed in kg/cm2.
Time Frame
At baseline, then at six, twelve weeks, and 3 months follow-up
Title
Change in Temporal Summation.
Description
Temporal Summation (TS) will be induced using a pressure algometer. For TS, 10 consecutive pressure pulses will be elicited using the PPT (obtained before). For each pulse of the TS procedure, the pressure will increase at a rate of 1 kg/second until the PPT is reached, where it will remain for one second before being released. The pressure pulses will be repeatedly performed with an interval between stimuli of one second. Participants will be instructed to assess the pain intensity of the first and tenth pressure pulses according to the NPRS. The TS score will be obtained by subtracting the first NPRS score from the last score. The higher the TS score, the more efficient nociceptive signaling for the brain.
Time Frame
At baseline, then at six, twelve weeks, and 3 months follow-up
Title
Change in Conditioned Pain Modulation.
Description
For the Conditioned Pain Modulation (CPM) a occlusion cuff will be used as a conditioning stimulus. The cuff will be inflated in the non-dominant arm at approximately 20 mm Hg/second until the subjects report experiencing pain at a value of 5/10 using the NPRS, when inflation will stop. Subjects will adapt to the stimulus for 30 seconds, and the first PPT measurement will be performed. Then, the cuff will then be deflated and 1 minute later the second PPT measurement will be taken.
Time Frame
At baseline, then at six, twelve weeks, and 3 months follow-up
Title
Change in Central Sensibilization Inventory.
Description
The Central Sensibilization Inventory (CSI) is a self-report outcome measure that consists of two parts. Part A consists of 25 statements where the participant must answer how often he/she experience each symptom. Individual items are scored from "0" (never) to "4" (always), resulting in a total score range for all 25 items from "0" to "100". Part B asks if the participant have been previously diagnosed by a doctor for some diseases (YES/NO). Part B of the CSI is for information only and is not qualified. A score of more than 40 indicates the presence of central sensitization.
Time Frame
At baseline, then at six, twelve weeks, and 3 months follow-up
Title
Change in Pain Catastrophizing Scale
Description
The Pain Catastrophizing scale (PCS) is a 13-items instrument that ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points being (0) not at all and, (4) all the time. A total score (ranging from 0 to 52) is obtained, along with three subscale scores that assess rumination, magnification, and helplessness. A higher total PCS score of 30 represents a clinically relevant level of catastrophizing.
Time Frame
At baseline, then at six, twelve weeks, and 3 months follow-up
Title
Change in Spanish version of the Tampa Scale of Kinesiophobia for Temporomandibular. Disorders
Description
The Spanish version of the Tampa Scale of Kinesiophobia for Temporomandibular Disorders (TSK-TMD-S) consists of 10 items formulated positively and distributed in 2 subscales as follows: (1) somatic approach (items 1, 2, 3, 4 and 10) and (2) avoidance of activities (items 5 to 9). The total score can range from 10 to 40 (somatic focus, 5-20; avoidance of activity, 5-20), with higher scores indicating an increased fear of jaw movement and re-injury. The cut-off point to consider kinesiophobia is 23 points.
Time Frame
At baseline, then at six, twelve weeks, and 3 months follow-up
Title
Change in Home exercise adherence
Description
To assess adherence to home exercise, a google form will be sent weekly to the volunteers. It will consist of questions related to the number of times patients performed the exercises during the week and to the difficulties they encountered. Adherence to exercises will be expressed as a percentage [(number of exercise sessions performed / number of exercise sessions prescribed) X100].
Time Frame
Between the sixth and twelfth week (once per week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mauro Barone, PT
Phone
+54 9 3412123037
Email
mbarone@ugr.edu.ar
Facility Information:
Facility Name
University of Gran Rosario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mauro Barone, PT
Phone
+54 9 3412123037
Email
mbarone@ugr.edu.ar

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs