Effectiveness of physical therapy in addition to occlusal splint in myogenic temporomandibular disorders: protocol of a randomised controlled trial

Cristina Incorvati, Antonio Romeo, Adele Fabrizi, Luca Defila, Carla Vanti, Maria Rosaria Antonella Gatto, Claudio Marchetti, Paolo Pillastrini, Cristina Incorvati, Antonio Romeo, Adele Fabrizi, Luca Defila, Carla Vanti, Maria Rosaria Antonella Gatto, Claudio Marchetti, Paolo Pillastrini

Abstract

Introduction: Temporomandibular disorders (TMDs) are considered a collection of musculoskeletal conditions involving the masticatory muscles, the temporomandibular joint and associated structures. The myogenous group appears to represent the most frequently diagnosed category. In the context of a multimodal approach, splint therapy and musculoskeletal physiotherapy are often considered as a preferred therapy. The purpose of this study will be to investigate the effects of musculoskeletal physiotherapy combined with occlusal splint and education versus occlusal splint and education alone in the treatment of chronic myogenous TMD on pain and mandibular range of motion.

Methods and analysis: All consecutive adults complaining of TMDs presented to the Department of Biomedical and Neuromotor Sciences of the University of Bologna will be considered eligible. Inclusion criteria shall be based on the presence of myogenous TMDs, as diagnosed through clinical examination in reference to the international diagnostic criteria of TMDs. Randomisation, concealed allocation, blinded assessment and intention-to-treat analysis will be employed. The splint therapy will consist of the use of the splint every night and concurrent delivery of an educational programme; the protocol shall have a duration of three consecutive months. The combined musculoskeletal physiotherapy, splint therapy and education will additionally consist of manual therapy techniques and exercise; such protocol shall consist of a duration of three consecutive months, inclusive of 10 sessions for the enhanced elements. All outcome measures will be collected at baseline, after treatment and at a 6 months follow-up.

Ethics and dissemination: Ethical approval has been obtained from the Independent Ethic Committee in Clinical Research of AUSL Bologna-Italy (47/2018/SPER/AUSLBO). Pursuant to applicable rules,we will obtain informed consent from each participant and collect data anonymously to maintain privacy. Results will be disseminated to clinicians and researchers through peer-reviewed publications and conferences.

Trial registration number: NCT03726060.

Keywords: Musculoskeletal disorders; ORAL MEDICINE; Rehabilitation medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow chart of the trial.

References

    1. Rinchuse DJ, Greene CS. Scoping review of systematic review Abstracts about temporomandibular disorders: comparison of search years 2004 and 2017. Am J Orthod Dentofacial Orthop 2018;154:35–46. 10.1016/j.ajodo.2017.12.011
    1. Leeuw R, Glasser G. American Academy of Oral Facial Pain. Diagnosis and management of TMDs : De Leeuw R, Glasser G, Orofacial pain: guidelines for classification, assessment, and management 5th ED. Chicago Quintessence Publ Co, 2013.
    1. Peck CC, Goulet J-P, Lobbezoo F, et al. . Expanding the taxonomy of the diagnostic criteria for temporomandibular disorders. J Oral Rehabil 2014;41:2–23. 10.1111/joor.12132
    1. Schiffman E, Ohrbach R, Truelove E, et al. . Diagnostic criteria for temporomandibular disorders (DC/TMD) for clinical and research applications: recommendations of the International RDC/TMD Consortium Network* and orofacial pain special interest group. J Oral Facial Pain Headache 2014;1:1–27.
    1. Schiffman E, Ohrbach R. Executive summary of the diagnostic criteria for temporomandibular disorders for clinical and research applications. J Am Dent Assoc 2016;147:438–45. 10.1016/j.adaj.2016.01.007
    1. Graff-Radford SB, Abbott JJ. Temporomandibular disorders and headache. Oral Maxillofac Surg Clin North Am 2016;28:335–49. 10.1016/j.coms.2016.03.004
    1. Visscher CM, Lobbezoo F, de Boer W, et al. . Prevalence of cervical spinal pain in craniomandibular pain patients. Eur J Oral Sci 2001;109:76–80. 10.1034/j.1600-0722.2001.00996.x
    1. de Wijer A, de Leeuw JR, Steenks MH, et al. . Temporomandibular and cervical spine disorders. self-reported signs and symptoms. Spine 1996;21:1638–6646. 10.1097/00007632-199607150-00005
    1. Grondin F, Hall T, Laurentjoye M, et al. . Upper cervical range of motion is impaired in patients with temporomandibular disorders. Cranio 2015;33:91–9. 10.1179/0886963414Z.00000000053
    1. Silveira A, Gadotti IC, Armijo-Olivo S, et al. . Jaw dysfunction is associated with neck disability and muscle tenderness in subjects with and without chronic temporomandibular disorders. Biomed Res Int 2015;2015:512792 10.1155/2015/512792
    1. Gonçalves DAG, Camparis CM, Speciali JG, et al. . Temporomandibular disorders are differentially associated with headache diagnoses: a controlled study. Clin J Pain 2011;27:611–5. 10.1097/AJP.0b013e31820e12f5
    1. Macfarlane TV, Glenny AM, Worthington HV. Systematic review of population-based epidemiological studies of oro-facial pain. J Dent 2001;29:451–67. 10.1016/S0300-5712(01)00041-0
    1. Magnusson T, Egermark I, Carlsson GE. A longitudinal epidemiologic study of signs and symptoms of temporomandibular disorders from 15 to 35 years of age. J Orofac Pain 2000;14:310–9.
    1. Slade GD, Ohrbach R, Greenspan JD, et al. . Painful temporomandibular disorder: decade of discovery from OPPERA studies. J Dent Res 2016;95:1084–92. 10.1177/0022034516653743
    1. Poveda-Roda R, Bagan JV, Sanchis JM, et al. . Temporomandibular disorders. A case-control study. Med Oral Patol Oral Cir Bucal 2012;175:e794–800.
    1. Manfredini D, Guarda-Nardini L, Winocur E, et al. . Research diagnostic criteria for temporomandibular disorders: a systematic review of axis I epidemiologic findings. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2011;112:453–62. 10.1016/j.tripleo.2011.04.021
    1. Fillingim RB, Ohrbach R, Greenspan JD, et al. . Psychological factors associated with development of TMD: the OPPERA prospective cohort study. J Pain 2013;14:T75–90. 10.1016/j.jpain.2013.06.009
    1. Manfredini D, Bandettini di Poggio A, Cantini E, et al. . Mood and anxiety psychopathology and temporomandibular disorder: a spectrum approach. J Oral Rehabil 2004;31:933–40. 10.1111/j.1365-2842.2004.01335.x
    1. Riley JL, Benson MB, Gremillion HA, et al. . Sleep disturbance in orofacial pain patients: pain-related or emotional distress? Cranio 2001;19:106–13. 10.1080/08869634.2001.11746159
    1. Häggman-Henrikson B, List T, Westergren HT, et al. . Temporomandibular disorder pain after whiplash trauma: a systematic review. J Orofac Pain 2013;27:217–26. 10.11607/jop.1027
    1. Fernández-de-las-Penas C, Svensson P. Myofascial temporomandibular disorder. Curr Rheumatol Rev 2016;12:40–54. 10.2174/1573397112666151231110947
    1. Greene CS, Menchel HF. The use of oral appliances in the management of temporomandibular disorders. Oral Maxillofac Surg Clin North Am 2018;30:265–77. 10.1016/j.coms.2018.04.003
    1. Kandasamy S, Greene CS, Rinchuse DJ, et al. . Tmd and Orthodontics: a clinical guide for the Orthodontist 1st ED. Switzerland: 2015 Springer International Publishing, 2015.
    1. Wieckiewicz M, Boening K, Wiland P, et al. . Reported concepts for the treatment modalities and pain management of temporomandibular disorders. J Headache Pain 2015;16:106. 10.1186/s10194-015-0586-5
    1. Dickerson SM, Weaver JM, Boyson AN, et al. . The effectiveness of exercise therapy for temporomandibular dysfunction: a systematic review and meta-analysis. Clin Rehabil 2017;31:1039–48. 10.1177/0269215516672275
    1. Martins WR, Blasczyk JC, Aparecida Furlan de Oliveira M, et al. . Efficacy of musculoskeletal manual approach in the treatment of temporomandibular joint disorder: a systematic review with meta-analysis. Man Ther 2016;21:10–17. 10.1016/j.math.2015.06.009
    1. Calixtre LB, Moreira RFC, Franchini GH, et al. . Manual therapy for the management of pain and limited range of motion in subjects with signs and symptoms of temporomandibular disorder: a systematic review of randomised controlled trials. J Oral Rehabil 2015;42:847–61. 10.1111/joor.12321
    1. Armijo-Olivo S, Pitance L, Singh V, et al. . Effectiveness of manual therapy and therapeutic exercise for temporomandibular disorders: systematic review and meta-analysis. Phys Ther 2016;96:9–25. 10.2522/ptj.20140548
    1. Michelotti A, Iodice G, Vollaro S, et al. . Evaluation of the short-term effectiveness of education versus an occlusal splint for the treatment of myofascial pain of the jaw muscles. J Am Dent Assoc 2012;143:47–53. 10.14219/jada.archive.2012.0018
    1. Delsnyder J, Colina T, Elsemary N, et al. . Stabilization appliances as treatment for myogenous temporo- mandibular disorders: a systematic review and meta-analysis. Open Journal of Dentistry and Oral Medicine 2017;5:72–84.
    1. Kuzmanovic Pficer J, Dodic S, Lazic V, et al. . Occlusal stabilization splint for patients with temporomandibular disorders: meta-analysis of short and long term effects. PLoS One 2017;12:e0171296. 10.1371/journal.pone.0171296
    1. Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med 2001;8:1153–7. 10.1111/j.1553-2712.2001.tb01132.x
    1. Gaston-Johansson F. Measurement of pain: the psychometric properties of the Pain-O-Meter, a simple, inexpensive pain assessment tool that could change health care practices. J Pain Symptom Manage 1996;12:172–81. 10.1016/0885-3924(96)00128-5
    1. Dworkin RH, Turk DC, Wyrwich KW, et al. . Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 2008;9:105–21. 10.1016/j.jpain.2007.09.005
    1. Calixtre LB, Oliveira AB, Alburquerque-Sendín F, et al. . What is the minimal important difference of pain intensity, mandibular function, and headache impact in patients with temporomandibular disorders? clinical significance analysis of a randomized controlled trial. Musculoskelet Sci Pract 2020;46:102108. 10.1016/j.msksp.2020.102108
    1. Breivik H, Borchgrevink PC, Allen SM, et al. . Assessment of pain. Br J Anaesth 2008;101:17–24. 10.1093/bja/aen103
    1. Dworkin SF, LeResche L, DeRouen T, et al. . Assessing clinical signs of temporomandibular disorders: reliability of clinical examiners. J Prosthet Dent 1990;63:574–9. 10.1016/0022-3913(90)90079-R
    1. Leher A, Graf K, PhoDuc J-M, et al. . Is there a difference in the reliable measurement of temporomandibular disorder signs between experienced and inexperienced examiners? J Orofac Pain 2005;19:58–64.
    1. Costantini M, Musso M, Viterbori P, et al. . Detecting psychological distress in cancer patients: validity of the Italian version of the hospital anxiety and depression scale. Support Care Cancer 1999;7:121–7. 10.1007/s005200050241
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983;67:361–70. 10.1111/j.1600-0447.1983.tb09716.x
    1. Bjelland I, Dahl AA, Haug TT, et al. . The validity of the hospital anxiety and depression scale. An updated literature review. J Psychosom Res 2002;52:69–77. 10.1016/s0022-3999(01)00296-3
    1. LoMartire R, Äng BO, Gerdle B, et al. . Psychometric properties of short Form-36 health survey, EuroQol 5-dimensions, and hospital anxiety and depression scale in patients with chronic pain. Pain 2020;161:83–95. 10.1097/j.pain.0000000000001700

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe