Temporomandibular DisorderNCT06502769
Efficacy of Therapeutic Exercise and Pain Neurophysiology Education in Temporomandibular Disorders
A study testing Therapeutic Exercise and Pain Neurophysiology Education in people with Temporomandibular Disorder, run by University of Alcala at 1 site in Spain.
Trial summary
The aim of this study is to compare the effects in pain of two different treatments in pacients with temporomandibular disorders (TMD). One group will receive isolated therapeutic exercise (TE) and the other will receive TE combined with pain neurophysiology education (PNE). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Therapeutic Exercise and Pain Neurophysiology Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Limitation of mouth opening and/or jaw pain lasting more than 6 months
- Being able to understand the objective and carry out the study procedures
- Sign the informed consent.
Who cannot join
- Suffer from any underlying disease
- Pain due to tumors or infections, metastases, osteoporosis, inflammatory arthritis or fractures
- Be receiving any other treatment for TMD or consuming some type of substance that alters muscle tone.
- Patients with myopathies, diseases of the Peripheral Nervous System, mental disorders diagnosed by a doctor
- Inability to collaborate
- Any other situation in which the evaluation could be altered.
Trial locations and contacts
1 site in 1 country.
Gema Bodes-Pardo, PhD contact
Spain1 site
Campus Científico Tecnológico UAH. AV. de León, 3A.
Alcalá de Henares, Madrid, 28804
María Teresa Ortiz-Moreno, MSc, +34662422993, teresa.ortizm@edu.uah.es
About this study
Official title: Efficacy of Therapeutic Exercise and Pain Neurophysiology Education in Temporomandibular Disorders: a Single-blind Randomized Controlled Trial
The aim of this study is to compare the effects in pain of two different treatments in pacients with temporomandibular disorders (TMD). One group will receive isolated therapeutic exercise (TE) and the other will receive TE combined with pain neurophysiology education (PNE). The hypothesis of this study is that the PNE+TE group will obtain superior therapeutic results than an isolated TE program.
Read the detailed description
Objective: To evaluate the differences in pain intensity by performing isolated therapeutic exercise (TE) versus performing the same exercise combined with pain neurophysiology education (PNE) in patients with temporomandibular disorders (TMD).
Design: Single-blind randomized controlled trial. Setting: Faculty of Physical Therapy of Alcalá de Henares. Participants: Subjects with TMD lasting more than 6 months (N= 36). Interventions: Participants will be randomly assigned to receive a TE program consisting of stretching, coordination and strengthening exercises (n= 18) or the same TE program in addition to a PNE program (n= 18), performed in two sessions of 40 minutes in groups of 6 participants. The intervention will last 12 weeks, where all participants must complete the exercise program daily, one year later they will be evaluated again.
Main outcome measures: The primary outcome will be pain intensity through the visual analogue scale (VAS) which will be completed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment. Secondary outcome measures include pain-free mouth opening, Craniofacial Pain and Disability Inventory (CF-PDI), Pain Catastrophizing Scale (PCS), Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-11), pressure pain thresholds (PPT) and Patient Global Impression of Change (PGIC). They will be recorded through blinded assessments performed by 2 physiotherapists at baseline, immediately after treatment, 4 and 12 weeks after treatment. Student's t test will be used to determine differences between group interventions.
- Conditions
- Temporomandibular Disorder
- Being tested
- Therapeutic Exercise, Pain Neurophysiology Education
- Keywords
- therapeutic exercise, pain neurophysiology, temporomandibular disorder
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic ExerciseBehavioural
A therapeutic exercise program will be carried out
Pain Neurophysiology EducationBehavioural
A PNE program will be carried out
| Study group | Role | What they receive |
|---|---|---|
| TE+PNE group | Experimental | patients with TMD who are going to combine therapeutic exercise with education in pain neurophysiology Receives: Behavioral: Therapeutic Exercise; Behavioral: Pain Neurophysiology Education |
| TE group | Other | patients with TMD who are going to perform isolated therapeutic exercise Receives: Behavioral: Therapeutic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
The intensity of pain will be evaluated using the Visual Analogue Scale that is represented by a 10cm line where the left end indicates "no pain" and the right end indicates "maximum pain".
Measured: The scale will be passed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment.
Secondary outcomes (6)
Mouth opening without pain
The distance between the upper and lower mandibular central incisors will be measured using a TheraBite range of motion scale.
Measured: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Orofacial disability and pain
The CF-PDI is a self-administered questionnaire that measures pain and disability outcomes related to craniofacial pain. It consists of 21 items, with a score ranging from 0 to 63 points. A higher score reflects higher levels of disability.
Measured: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Catastrophism
The PCS consists of a self-administered questionnaire with 13 items for the evaluation of catastrophic thoughts. It is divided into three domains: helplessness, magnification and rumination. Higher values denote greater pain catastrophizing
Measured: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Kinesiophobia
The Spanish version of the TSK-11 will be used to evaluate the fear of re-injury due to movement. This questionnaire has a structure of 11 items and 2 factors that includes avoidance and harm of activities. Higher scores reflect greater fear of movement
Measured: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Pressure pain thresholds
The masseter and anterior temporal PPTs will be assessed bilaterally using an analog algometer. Measurements will be reported in kg/cm2. The points will always be evaluated in the same order and will be repeated three times, with an interval of 1 minute. For each point the average of the three measurements will be considered.
Measured: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Self-Perception of Improvement
PGIC will be used to assess perceived improvement after treatment (range, 0-7). Higher scores will indicate greater improvement
Measured: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Teresa Ortiz Moreno, University of Alcala
- Investigators
- María Teresa Ortiz-Moreno, MSc, Principal investigator, University of AlcaláGema Bodes-Pardo, PhD, Study director, University of Alcalá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502769
- Sponsor's protocol ID
- Temporomandibular Disorders
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Calixtre LB, Gruninger BL, Haik MN, Alburquerque-Sendin F, Oliveira AB. Effects of cervical mobilization and exercise on pain, movement and function in subjects with temporomandibular disorders: a single group pre-post test. J Appl Oral Sci. 2016 May-Jun;24(3):188-97. doi: 10.1590/1678-775720150240.
PubMed 27383698Chellappa D, Thirupathy M. Comparative efficacy of low-Level laser and TENS in the symptomatic relief of temporomandibular joint disorders: A randomized clinical trial. Indian J Dent Res. 2020 Jan-Feb;31(1):42-47. doi: 10.4103/ijdr.IJDR_735_18.
PubMed 32246680Sousa BM, Lopez-Valverde N, Lopez-Valverde A, Caramelo F, Fraile JF, Payo JH, Rodrigues MJ. Different Treatments in Patients with Temporomandibular Joint Disorders: A Comparative Randomized Study. Medicina (Kaunas). 2020 Mar 5;56(3):113. doi: 10.3390/medicina56030113.
PubMed 32151101Dos Santos Aguiar A, Bataglion C, Felicio LR, Azevedo B, Chaves TC. Additional effect of pain neuroscience education to craniocervical manual therapy and exercises for pain intensity and disability in temporomandibular disorders: a study protocol for a randomized controlled trial. Trials. 2021 Sep 6;22(1):596. doi: 10.1186/s13063-021-05532-x.
PubMed 34488856Wanman A, Marklund S. Treatment outcome of supervised exercise, home exercise and bite splint therapy, respectively, in patients with symptomatic disc displacement with reduction: A randomised clinical trial. J Oral Rehabil. 2020 Feb;47(2):143-149. doi: 10.1111/joor.12888. Epub 2019 Sep 30.
PubMed 31520538Yamaguchi Y, Sakuma S, Takagi S, Ogi N, Kurita K, Ariji Y, Taguchi N. Efficacy of therapeutic exercise for temporomandibular disorders as assessed by magnetic resonance imaging: a case report. J Phys Ther Sci. 2020 Jul;32(7):477-482. doi: 10.1589/jpts.32.477. Epub 2020 Jul 3.
PubMed 32753791Garrigos-Pedron M, La Touche R, Navarro-Desentre P, Gracia-Naya M, Segura-Orti E. Effects of a Physical Therapy Protocol in Patients with Chronic Migraine and Temporomandibular Disorders: A Randomized, Single-Blinded, Clinical Trial. J Oral Facial Pain Headache. 2018 Spring;32(2):137-150. doi: 10.11607/ofph.1912.
PubMed 29694464Michelotti A, de Wijer A, Steenks M, Farella M. Home-exercise regimes for the management of non-specific temporomandibular disorders. J Oral Rehabil. 2005 Nov;32(11):779-85. doi: 10.1111/j.1365-2842.2005.01513.x.
PubMed 16202040Malfliet A, Kregel J, Coppieters I, De Pauw R, Meeus M, Roussel N, Cagnie B, Danneels L, Nijs J. Effect of Pain Neuroscience Education Combined With Cognition-Targeted Motor Control Training on Chronic Spinal Pain: A Randomized Clinical Trial. JAMA Neurol. 2018 Jul 1;75(7):808-817. doi: 10.1001/jamaneurol.2018.0492.
PubMed 29710099Bodes Pardo G, Lluch Girbes E, Roussel NA, Gallego Izquierdo T, Jimenez Penick V, Pecos Martin D. Pain Neurophysiology Education and Therapeutic Exercise for Patients With Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):338-347. doi: 10.1016/j.apmr.2017.10.016. Epub 2017 Nov 11.
PubMed 29138049
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Therapeutic Exercise and Pain Neurophysiology Education in Temporomandibular Disorders: a Single-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06502769
- Acronym / sponsor ID
- Temporomandibular Disorders
- Conditions
- Temporomandibular Disorder
- Keywords
- therapeutic exercise, pain neurophysiology, temporomandibular disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the effects in pain of two different treatments in pacients with temporomandibular disorders (TMD). One group will receive isolated therapeutic exercise (TE) and the other will receive TE combined with pain neurophysiology education (PNE). The hypothesis of this study is that the PNE+TE group will obtain superior therapeutic results than an isolated TE program.
Detailed description
Objective: To evaluate the differences in pain intensity by performing isolated therapeutic exercise (TE) versus performing the same exercise combined with pain neurophysiology education (PNE) in patients with temporomandibular disorders (TMD).
Design: Single-blind randomized controlled trial. Setting: Faculty of Physical Therapy of Alcalá de Henares. Participants: Subjects with TMD lasting more than 6 months (N= 36). Interventions: Participants will be randomly assigned to receive a TE program consisting of stretching, coordination and strengthening exercises (n= 18) or the same TE program in addition to a PNE program (n= 18), performed in two sessions of 40 minutes in groups of 6 participants. The intervention will last 12 weeks, where all participants must complete the exercise program daily, one year later they will be evaluated again.
Main outcome measures: The primary outcome will be pain intensity through the visual analogue scale (VAS) which will be completed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment. Secondary outcome measures include pain-free mouth opening, Craniofacial Pain and Disability Inventory (CF-PDI), Pain Catastrophizing Scale (PCS), Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-11), pressure pain thresholds (PPT) and Patient Global Impression of Change (PGIC). They will be recorded through blinded assessments performed by 2 physiotherapists at baseline, immediately after treatment, 4 and 12 weeks after treatment. Student's t test will be used to determine differences between group interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TE+PNE group | Experimental | Behavioral: Therapeutic Exercise, Behavioral: Pain Neurophysiology Educationpatients with TMD who are going to combine therapeutic exercise with education in pain neurophysiology |
| TE group | Other | Behavioral: Therapeutic Exercisepatients with TMD who are going to perform isolated therapeutic exercise |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years of age
- Limitation of mouth opening and/or jaw pain lasting more than 6 months
- Being able to understand the objective and carry out the study procedures
- Sign the informed consent.
Key exclusion criteria (6 listed)
- Suffer from any underlying disease
- Pain due to tumors or infections, metastases, osteoporosis, inflammatory arthritis or fractures
- Be receiving any other treatment for TMD or consuming some type of substance that alters muscle tone.
- Patients with myopathies, diseases of the Peripheral Nervous System, mental disorders diagnosed by a doctor
- Inability to collaborate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic ExerciseA therapeutic exercise program will be carried out | Behavioural | TE group, TE+PNE group |
| Pain Neurophysiology EducationA PNE program will be carried out | Behavioural | TE+PNE group |
Primary outcome
Pain intensity
Time frame: The scale will be passed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment.
The intensity of pain will be evaluated using the Visual Analogue Scale that is represented by a 10cm line where the left end indicates "no pain" and the right end indicates "maximum pain".
6 secondary outcomes
Mouth opening without pain
Time frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Orofacial disability and pain
Time frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Catastrophism
Time frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Kinesiophobia
Time frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Pressure pain thresholds
Time frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Self-Perception of Improvement
Time frame: at baseline, immediately after treatment, 4 and 12 weeks after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Background: PubMed 27383698Calixtre LB, Gruninger BL, Haik MN, Alburquerque-Sendin F, Oliveira AB. Effects of cervical mobilization and exercise on pain, movement and function in subjects with temporomandibular disorders: a single group pre-post test. J Appl Oral Sci. 2016 May-Jun;24(3):188-97. doi: 10.1590/1678-775720150240.
- Background: PubMed 32246680Chellappa D, Thirupathy M. Comparative efficacy of low-Level laser and TENS in the symptomatic relief of temporomandibular joint disorders: A randomized clinical trial. Indian J Dent Res. 2020 Jan-Feb;31(1):42-47. doi: 10.4103/ijdr.IJDR_735_18.
- Background: PubMed 32151101Sousa BM, Lopez-Valverde N, Lopez-Valverde A, Caramelo F, Fraile JF, Payo JH, Rodrigues MJ. Different Treatments in Patients with Temporomandibular Joint Disorders: A Comparative Randomized Study. Medicina (Kaunas). 2020 Mar 5;56(3):113. doi: 10.3390/medicina56030113.
- Background: PubMed 34488856Dos Santos Aguiar A, Bataglion C, Felicio LR, Azevedo B, Chaves TC. Additional effect of pain neuroscience education to craniocervical manual therapy and exercises for pain intensity and disability in temporomandibular disorders: a study protocol for a randomized controlled trial. Trials. 2021 Sep 6;22(1):596. doi: 10.1186/s13063-021-05532-x.
- Background: PubMed 31520538Wanman A, Marklund S. Treatment outcome of supervised exercise, home exercise and bite splint therapy, respectively, in patients with symptomatic disc displacement with reduction: A randomised clinical trial. J Oral Rehabil. 2020 Feb;47(2):143-149. doi: 10.1111/joor.12888. Epub 2019 Sep 30.
- Background: PubMed 32753791Yamaguchi Y, Sakuma S, Takagi S, Ogi N, Kurita K, Ariji Y, Taguchi N. Efficacy of therapeutic exercise for temporomandibular disorders as assessed by magnetic resonance imaging: a case report. J Phys Ther Sci. 2020 Jul;32(7):477-482. doi: 10.1589/jpts.32.477. Epub 2020 Jul 3.
- Background: PubMed 29694464Garrigos-Pedron M, La Touche R, Navarro-Desentre P, Gracia-Naya M, Segura-Orti E. Effects of a Physical Therapy Protocol in Patients with Chronic Migraine and Temporomandibular Disorders: A Randomized, Single-Blinded, Clinical Trial. J Oral Facial Pain Headache. 2018 Spring;32(2):137-150. doi: 10.11607/ofph.1912.
- Background: PubMed 16202040Michelotti A, de Wijer A, Steenks M, Farella M. Home-exercise regimes for the management of non-specific temporomandibular disorders. J Oral Rehabil. 2005 Nov;32(11):779-85. doi: 10.1111/j.1365-2842.2005.01513.x.
- Background: PubMed 29710099Malfliet A, Kregel J, Coppieters I, De Pauw R, Meeus M, Roussel N, Cagnie B, Danneels L, Nijs J. Effect of Pain Neuroscience Education Combined With Cognition-Targeted Motor Control Training on Chronic Spinal Pain: A Randomized Clinical Trial. JAMA Neurol. 2018 Jul 1;75(7):808-817. doi: 10.1001/jamaneurol.2018.0492.
- Background: PubMed 29138049Bodes Pardo G, Lluch Girbes E, Roussel NA, Gallego Izquierdo T, Jimenez Penick V, Pecos Martin D. Pain Neurophysiology Education and Therapeutic Exercise for Patients With Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):338-347. doi: 10.1016/j.apmr.2017.10.016. Epub 2017 Nov 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gema Bodes-Pardo, PhD contact
María Teresa Ortiz-Moreno, MSc principal investigator
University of Alcalá
Gema Bodes-Pardo, PhD study director
University of Alcalá
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Exercise and Pain Neurophysiology Education in people with Temporomandibular Disorder, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María Teresa Ortiz-Moreno, MSc (+34662422993, teresa.ortizm@edu.uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: The scale will be passed at baseline, immediately after treatment, at 4 and 12 weeks and one year after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06502769, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.