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

NCT ID: NCT07147764

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-14

Study Completion Date

2026-06-30

Brief Summary

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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:

Control Group: Physiotherapy only

PNE Group: Physiotherapy plus Pain Neuroscience Education

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

Detailed Description

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Conditions

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Temporomandibular Joint Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group (CG): Physiotherapy

Group Type ACTIVE_COMPARATOR

Physiotherapy

Intervention Type OTHER

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

Pain Neuroscience Group (PNEG): Physiotherapy + Pain Neuroscience Education

Group Type EXPERIMENTAL

Pain Neuroscience Education

Intervention Type BEHAVIORAL

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.

Interventions

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Physiotherapy

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

Intervention Type OTHER

Pain Neuroscience Education

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medipol University

OTHER

Sponsor Role collaborator

Ainaz Shahedi

OTHER

Sponsor Role lead

Responsible Party

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Ainaz Shahedi

MSc Candidate in Physiotherapy, Istanbul Medipol University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gizem Ergezen Şahin, Dr. Assistant Professor

Role: STUDY_DIRECTOR

Department of Physiotherapy and Rehabilitation/Istanbul Medipol University

Locations

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Istanbul Medipol University

Istanbul, Kavacik, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ainaz Shahedi, PT, MSc (Cand.)

Role: CONTACT

+90-542-733-1783

Facility Contacts

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Ainaz Shahedi

Role: primary

+905427331783

References

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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.

Reference Type BACKGROUND
PMID: 38353484 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38894567 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30178503 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38674202 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28640822 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30826805 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30831273 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36901108 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38835986 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36277551 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38101924 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34948580 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36293017 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36760766 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39827051 (View on PubMed)

Li DTS, Leung YY. Temporomandibular Disorders: Current Concepts and Controversies in Diagnosis and Management. Diagnostics (Basel). 2021 Mar 6;11(3):459. doi: 10.3390/diagnostics11030459.

Reference Type BACKGROUND
PMID: 33800948 (View on PubMed)

Dos 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.

Reference Type BACKGROUND
PMID: 34488856 (View on PubMed)

Ferneini EM. Temporomandibular Joint Disorders (TMD). J Oral Maxillofac Surg. 2021 Oct;79(10):2171-2172. doi: 10.1016/j.joms.2021.07.008. No abstract available.

Reference Type BACKGROUND
PMID: 34620421 (View on PubMed)

Chimenti RL, Frey-Law LA, Sluka KA. A Mechanism-Based Approach to Physical Therapist Management of Pain. Phys Ther. 2018 May 1;98(5):302-314. doi: 10.1093/ptj/pzy030.

Reference Type BACKGROUND
PMID: 29669091 (View on PubMed)

Busse JW, Casassus R, Carrasco-Labra A, Durham J, Mock D, Zakrzewska JM, Palmer C, Samer CF, Coen M, Guevremont B, Hoppe T, Guyatt GH, Crandon HN, Yao L, Sadeghirad B, Vandvik PO, Siemieniuk RAC, Lytvyn L, Hunskaar BS, Agoritsas T. Management of chronic pain associated with temporomandibular disorders: a clinical practice guideline. BMJ. 2023 Dec 15;383:e076227. doi: 10.1136/bmj-2023-076227.

Reference Type BACKGROUND
PMID: 38101929 (View on PubMed)

List T, Jensen RH. Temporomandibular disorders: Old ideas and new concepts. Cephalalgia. 2017 Jun;37(7):692-704. doi: 10.1177/0333102416686302. Epub 2017 Jan 9.

Reference Type BACKGROUND
PMID: 28068790 (View on PubMed)

Liou YJ, Bai YM, Tsai SJ, Chen TJ, Chen MH, Lo WL. Bidirectional Associations of Temporomandibular Joint Disorders with Major Depressive and Anxiety Disorders. J Evid Based Dent Pract. 2023 Jun;23(2):101860. doi: 10.1016/j.jebdp.2023.101860. Epub 2023 Mar 17.

Reference Type BACKGROUND
PMID: 37201980 (View on PubMed)

Al-Jewair T, Shibeika D, Ohrbach R. Temporomandibular Disorders and Their Association with Sleep Disorders in Adults: A Systematic Review. J Oral Facial Pain Headache. 2021 Winter;35(1):41-53. doi: 10.11607/ofph.2780.

Reference Type BACKGROUND
PMID: 33730126 (View on PubMed)

A. Aggarwal, J. Gadekar, and P. Kakodkar, "Role of Myofascial Release Technique on Mobility and Function in Temporomandibular Joint Disorder Patients with Neck Pain," J. Dent. Res. Rev., vol. 7, no. Suppl 1, 2020

Reference Type BACKGROUND

Zielinski G, Pajak-Zielinska B, Ginszt M. A Meta-Analysis of the Global Prevalence of Temporomandibular Disorders. J Clin Med. 2024 Feb 28;13(5):1365. doi: 10.3390/jcm13051365.

Reference Type BACKGROUND
PMID: 38592227 (View on PubMed)

McNeill C. Management of temporomandibular disorders: concepts and controversies. J Prosthet Dent. 1997 May;77(5):510-22. doi: 10.1016/s0022-3913(97)70145-8.

Reference Type BACKGROUND
PMID: 9151272 (View on PubMed)

Other Identifiers

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E-10840098-202.3.02-2936

Identifier Type: -

Identifier Source: org_study_id

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