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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• The Craniofacial Pain and Disability Inventory (CF-PDI) [Срок оценки: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up]

Вторичные конечные точки (8)

• Numeric Pain Rating Scale (NPRS) [Срок оценки: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up]
• Pain Self-Efficacy Questionnaire (PSEQ) [Срок оценки: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up]
• Pain Catastrophizing Scale (PCS) [Срок оценки: Baseline,1 month after start of treatment, Immediate post-treatment, 3 month follow up]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: 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) [Срок оценки: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up]
• Revised Neurophysiology of Pain Questionnaire (rNPQ) [Срок оценки: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up]
• The Exercise Adherence Rating Scale (EARS) [Срок оценки: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up]
• Fear Avoidance Components Scale (FACS) [Срок оценки: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul Medipol University — Istanbul

Публикации

• 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

Идентификаторы

NCT: NCT07147764 · E-10840098-202.3.02-2936

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗