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| Name | Class |
|---|---|
| Medipol University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group (CG): Physiotherapy | Active Comparator |
| |
| Pain Neuroscience Group (PNEG): Physiotherapy + Pain Neuroscience Education | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physiotherapy | Other | Physiotherapy treatment programs include therapeutic ultrasound, muscle relaxation techniques, range of motion exercises, and joint and soft tissue mobilization. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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),. | Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up |
| Pain Self-Efficacy Questionnaire (PSEQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ainaz Shahedi, PT, MSc (Cand.) | Contact | +90-542-733-1783 | shahediainaz1@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gizem Ergezen Åžahin, Dr. Assistant Professor | Department of Physiotherapy and Rehabilitation/Istanbul Medipol University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medipol University | Recruiting | Istanbul | Kavacik | 34810 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38353484 | Background | 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. | |
| 38894567 |
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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.
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| Pain Neuroscience Education | 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. |
|
It consists of 10 items scored on a 7-point ordinal scale (ranging from 0: "not at all confident" to 6: "completely confident"). |
| Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up |
| 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. | Baseline,1 month after start of treatment, Immediate post-treatment, 3 month follow up |
| 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. | 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) | 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). | Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up |
| 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. | Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up |
| 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. | Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up |
| 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. | Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up |
| 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. |
| 30178503 | Background | 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. |
| 38674202 | Background | 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. |
| 28640822 | Background | 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. |
| 30826805 | Background | 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. |
| 30831273 | Background | 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. |
| 36901108 | Background | 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. |
| 38835986 | Background | 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. |
| 36277551 | Background | 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. |
| 38101924 | Background | 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. |
| 34948580 | Background | 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. |
| 36293017 | Background | 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. |
| 36760766 | Background | 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. |
| 39827051 | Background | 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. |
| 33800948 | Background | 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. |
| 34488856 | Background | 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. |
| 34620421 | Background | 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. |
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| 38101929 | Background | 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. |
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| 33730126 | Background | 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. |
| Background | 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 |
| 38592227 | 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. |
| 9151272 | Background | 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. |
| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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