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Recruiting NCT07147764

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

No phase Interventional Temporomandibular Joint Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physiotherapy, Pain Neuroscience Education.
Who it may be relevant to
Registry conditions: Temporomandibular Joint Disorders. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • The Craniofacial Pain and Disability Inventory (CF-PDI) [Time frame: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up]
Secondary outcome measures (8)
  • Numeric Pain Rating Scale (NPRS) [Time frame: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up]
  • Pain Self-Efficacy Questionnaire (PSEQ) [Time frame: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up]
  • Pain Catastrophizing Scale (PCS) [Time frame: Baseline,1 month after start of treatment, Immediate post-treatment, 3 month follow up]
  • Hospital Anxiety and Depression Scale (HADS) [Time frame: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up]
  • The Tampa Scale for Kinesiophobia specific to Temporomandibular Disorders (TSK-TMD) [Time frame: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up]
  • Revised Neurophysiology of Pain Questionnaire (rNPQ) [Time frame: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up]
  • The Exercise Adherence Rating Scale (EARS) [Time frame: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up]
  • Fear Avoidance Components Scale (FACS) [Time frame: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul Medipol University — Istanbul

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 36901108

Identifiers

NCT: NCT07147764 · E-10840098-202.3.02-2936

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗