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Temporomandibular Joint DisordersNCT07147764

Comparison of the Effect of Pain Neuroscience Education Combined With Physiotherapy, and Physiotherapy Alone in Temporomandibular Disorders

A study testing Physiotherapy and Pain Neuroscience Education in people with Temporomandibular Joint Disorders, run by Ainaz Shahedi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research study aims to evaluate the effectiveness of Pain Neuroscience Education (PNE) when it is added to a physiotherapy program for people experiencing chronic temporomandibular disorders (TMD). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Temporomandibular Joint Disorders
What is being tested?
Physiotherapy and Pain Neuroscience Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteTurkey (Türkiye)
Study dates
14 Jun 2025to 30 Jun 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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with pain-related TMDs according to DC/TMD guidelines
  • Chronic TMD pain, defined as experiencing pain for at least six months and feeling the pain during the last 30 days
  • Age between 18-65 years

Who cannot join

  • Illiterate patients
  • Severe depression (medical diagnoses)
  • Previous diagnosis of uncontrolled psychiatric disorder neurodegenerative diseases
  • Clinical history of tumors in the craniofacial region
  • Patients in the post dental surgery period
  • Patients who were submitted to previous physical therapy in the past year or to any health/pain education strategy
  • Pregnant women
  • Infections, whiplash-associated disorders and with chronic degenerative inflammatory or neurologic disorders

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Medipol University

    Istanbul, Kavacik, 34810

Other trials in Turkey (Türkiye)

About this study

This research study aims to evaluate the effectiveness of Pain Neuroscience Education (PNE) when it is added to a physiotherapy program for people experiencing chronic temporomandibular disorders (TMD). To see whether adding PNE to physiotherapy program would provides additional benefits in reducing pain intensity, improving psychological well-being, and enhancing functional outcomes. The findings are expected to provide new insights into more comprehensive and patient-centered treatment strategies for managing chronic TMD.

Participants will be randomly assigned to one of two groups:

Read more

Control Group: Physiotherapy only

PNE Group: Physiotherapy plus Pain Neuroscience Education

Both groups will receive their respective treatments for a set period of time.

Being tested
Physiotherapy, Pain Neuroscience Education
Keywords
Temporomandibular Disorder, Pain Neuroscience Education, Chronic Pain
Medical subject headings
Temporomandibular Joint Disorders, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PhysiotherapyOther

    Physiotherapy treatment programs include therapeutic ultrasound, muscle relaxation techniques, range of motion exercises, and joint and soft tissue mobilization.

  • Pain Neuroscience EducationBehavioural

    PNE sessions will be conducted in addition to physiotherapy programs for intervention groups. PNE sessions will occupy half of each session during the first two weeks. Physiotherapists trained in PNE will deliver sessions using a combination of metaphors, animated videos, and scientifically accurate descriptions. The same physiotherapist will lead both sessions with the same patient.

    Active learning techniques will include:

    Connecting new information with prior knowledge. Operationalizing key pain concepts into individual contexts. Facilitated problem-solving and critical reflection.

Study groups in NCT07147764
Study groupRoleWhat they receive
Control group (CG): PhysiotherapyActive comparatorNot described
Receives: Other: Physiotherapy
Pain Neuroscience Group (PNEG): Physiotherapy + Pain Neuroscience EducationExperimentalNot described
Receives: Behavioral: Pain Neuroscience Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Craniofacial Pain and Disability Inventory (CF-PDI)

    It consists of 21 items, with a 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 disability levels.

    Measured: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up

Secondary outcomes (8)
  1. Numeric Pain Rating Scale (NPRS)

    It includes an 11-point numerical rating scale, ranging from 0, indicating (no pain), to 10, representing (the worst pain imaginable),.

    Measured: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up

  2. Pain Self-Efficacy Questionnaire (PSEQ)

    It consists of 10 items scored on a 7-point ordinal scale (ranging from 0: "not at all confident" to 6: "completely confident").

    Measured: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up

  3. Pain Catastrophizing Scale (PCS)

    It consists of 13 items for the assessment of catastrophizing thoughts. It is divided into three domains: helplessness, magnification, and rumination. Each item is scored on a 5-point ordinal scale. The PCS total score ranges from 0 to 52 points, higher values denote greater pain catastrophizing.

    Measured: Baseline,1 month after start of treatment, Immediate post-treatment, 3 month follow up

  4. Hospital Anxiety and Depression Scale (HADS)

    It comprises two subscales: HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D), each consisting of seven items distributed throughout the questionnaire. Every item is rated on a 4-point Likert scale ranging from 0 to 3, reflecting the severity of symptoms. A score of 8 or above on either subscale is considered indicative of possible anxiety or depression.

    Measured: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up

  5. The Tampa Scale for Kinesiophobia specific to Temporomandibular Disorders (TSK-TMD)

    It consists of 12 items. Each item is scored on a 4-point ordinal scale, ranging from "strongly disagree" (score = 1) to "strongly agree" (score = 4). Ratings are summed to yield a total score. Higher scores reflect a greater fear of movement (12-48 points).

    Measured: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up

  6. Revised Neurophysiology of Pain Questionnaire (rNPQ)

    It includes 12 items, each requiring a true, false, or undecided response. Each correct answer receives one point, while incorrect or undecided answers receive zero. Total scores range from 0 to 12, with higher scores reflecting greater knowledge of pain-related physiological concepts.

    Measured: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up

  7. The Exercise Adherence Rating Scale (EARS)

    The tool consists of six items rated on a five-point Likert scale, ranging from 0 (strongly agree) to 4 (totally disagree). Items with positively worded statements are reverse-scored to maintain consistency in interpretation. The total adherence score ranges from 0 to 24, with higher scores indicating greater adherence to the exercise regimen.

    Measured: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up

  8. Fear Avoidance Components Scale (FACS)

    This self-administered questionnaire comprises 20 items rated on a 6-point Likert scale, ranging from 0 (completely disagree) to 6 (completely agree), yielding a maximum score of 100. Higher scores indicate stronger fear-avoidance beliefs.

    Measured: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2025
  2. Study start14 Jun 2025
  3. Primary completion30 Jun 2026
  4. Study completion30 Jun 2026

Resources

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
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07147764
Sponsor's protocol ID
E-10840098-202.3.02-2936
Status last verified
Oct 2026
First submitted
22 Aug 2025
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: At present, there is no plan to share individual participant data (IPD) outside the research team due to the small sample size and confidentiality considerations. However, in the future, de-identified data may be shared if required by institutional policy, journal requirements, or upon reasonable request from qualified researchers, always in accordance with ethical and legal standards.

Publications

  • Justribo-Manion C, Mesa-Jimenez J, Bara-Casaus J, Zuil-Escobar JC, Wachowska K, Alvarez-Bustins G. Additional effects of therapeutic exercise and education on manual therapy for chronic temporomandibular disorders treatment: a randomized clinical trial. Physiother Theory Pract. 2025 Jan;41(1):12-27. doi: 10.1080/09593985.2024.2316305. Epub 2024 Feb 14.

    PubMed 38353484
  • von Piekartz H, Bleiss S, Herzer S, Hall T, Ballenberger N. Does combining oro-facial manual therapy with bruxism neuroscience education affect pain and function in cases of awake bruxism? A pilot study. J Oral Rehabil. 2024 Sep;51(9):1692-1700. doi: 10.1111/joor.13740. Epub 2024 Jun 18.

    PubMed 38894567
  • Wood L, Hendrick PA. A systematic review and meta-analysis of pain neuroscience education for chronic low back pain: Short-and long-term outcomes of pain and disability. Eur J Pain. 2019 Feb;23(2):234-249. doi: 10.1002/ejp.1314. Epub 2018 Oct 14.

    PubMed 30178503
  • Kasimis K, Apostolou T, Kallistratos I, Lytras D, Iakovidis P. Effects of Manual Therapy Plus Pain Neuroscience Education with Integrated Motivational Interviewing in Individuals with Chronic Non-Specific Low Back Pain: A Randomized Clinical Trial Study. Medicina (Kaunas). 2024 Mar 29;60(4):556. doi: 10.3390/medicina60040556.

    PubMed 38674202
  • Babatunde OO, Jordan JL, Van der Windt DA, Hill JC, Foster NE, Protheroe J. Effective treatment options for musculoskeletal pain in primary care: A systematic overview of current evidence. PLoS One. 2017 Jun 22;12(6):e0178621. doi: 10.1371/journal.pone.0178621. eCollection 2017.

    PubMed 28640822
  • Lin I, Wiles L, Waller R, Goucke R, Nagree Y, Gibberd M, Straker L, Maher CG, O'Sullivan PPB. What does best practice care for musculoskeletal pain look like? Eleven consistent recommendations from high-quality clinical practice guidelines: systematic review. Br J Sports Med. 2020 Jan;54(2):79-86. doi: 10.1136/bjsports-2018-099878. Epub 2019 Mar 2.

    PubMed 30826805
  • Watson JA, Ryan CG, Cooper L, Ellington D, Whittle R, Lavender M, Dixon J, Atkinson G, Cooper K, Martin DJ. Pain Neuroscience Education for Adults With Chronic Musculoskeletal Pain: A Mixed-Methods Systematic Review and Meta-Analysis. J Pain. 2019 Oct;20(10):1140.e1-1140.e22. doi: 10.1016/j.jpain.2019.02.011. Epub 2019 Mar 1.

    PubMed 30831273
  • Lepri B, Romani D, Storari L, Barbari V. Effectiveness of Pain Neuroscience Education in Patients with Chronic Musculoskeletal Pain and Central Sensitization: A Systematic Review. Int J Environ Res Public Health. 2023 Feb 24;20(5):4098. doi: 10.3390/ijerph20054098.

    PubMed 36901108
  • Louw A, Schuemann T, Zimney K, Puentedura EJ. Pain Neuroscience Education for Acute Pain. Int J Sports Phys Ther. 2024 Jun 2;19(6):758-767. doi: 10.26603/001c.118179. eCollection 2024.

    PubMed 38835986
  • Wadhokar OC, Patil DS. Current Trends in the Management of Temporomandibular Joint Dysfunction: A Review. Cureus. 2022 Sep 19;14(9):e29314. doi: 10.7759/cureus.29314. eCollection 2022 Sep.

    PubMed 36277551
  • Yao L, Sadeghirad B, Li M, Li J, Wang Q, Crandon HN, Martin G, Morgan R, Florez ID, Hunskaar BS, Wells J, Moradi S, Zhu Y, Ahmed MM, Gao Y, Cao L, Yang K, Tian J, Li J, Zhong L, Couban RJ, Guyatt GH, Agoritsas T, Busse JW. Management of chronic pain secondary to temporomandibular disorders: a systematic review and network meta-analysis of randomised trials. BMJ. 2023 Dec 15;383:e076226. doi: 10.1136/bmj-2023-076226.

    PubMed 38101924
  • Urbanski P, Trybulec B, Pihut M. The Application of Manual Techniques in Masticatory Muscles Relaxation as Adjunctive Therapy in the Treatment of Temporomandibular Joint Disorders. Int J Environ Res Public Health. 2021 Dec 8;18(24):12970. doi: 10.3390/ijerph182412970.

    PubMed 34948580
  • Ferrillo M, Giudice A, Marotta N, Fortunato F, Di Venere D, Ammendolia A, Fiore P, de Sire A. Pain Management and Rehabilitation for Central Sensitization in Temporomandibular Disorders: A Comprehensive Review. Int J Mol Sci. 2022 Oct 12;23(20):12164. doi: 10.3390/ijms232012164.

    PubMed 36293017
  • Garstka AA, Kozowska L, Kijak K, Brzozka M, Gronwald H, Skomro P, Lietz-Kijak D. Accurate Diagnosis and Treatment of Painful Temporomandibular Disorders: A Literature Review Supplemented by Own Clinical Experience. Pain Res Manag. 2023 Jan 31;2023:1002235. doi: 10.1155/2023/1002235. eCollection 2023.

    PubMed 36760766
  • Cho YK, Jung YL, Im A, Hong SJ, Kim K. Social Media-Based Pain Neuroscience Education for Temporomandibular Joint Disorder: A Randomized Controlled Trial. Pain Manag Nurs. 2025 Jun;26(3):e261-e269. doi: 10.1016/j.pmn.2024.12.010. Epub 2025 Jan 17.

    PubMed 39827051

Questions about this trial

What is this clinical trial studying?

A study testing Physiotherapy and Pain Neuroscience Education in people with Temporomandibular Joint Disorders, run by Ainaz Shahedi at 1 site in Turkey (Türkiye).

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 3 inclusion and 8 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: finished, as of the sponsor's last update on 6 Oct 2026. 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Craniofacial Pain and Disability Inventory (CF-PDI) (time frame: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up). 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 NCT07147764, which also lists 26 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 6 Oct 2026.

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