Treatment of Temporo-Myofascial Disorder of Muscular Origin Using Botulinum Toxin: A Prospective Study
Summary
Temporomandibular disorders (TMD) are a group of conditions involving the temporomandibular joint (TMJ), masticatory muscles and associated structures. This broad complex of functional disorders often affects the face and jaws causing chronic pain, earaches, headaches, migraines, neck pain, and dysfunction in many people. Patients that do not find benefit with conservative management require surgical intervention. Recently, the use of botulinum toxin has proven effective and has the potential to bridge the gap between conservative therapy and surgical management resulting in less patients requiring invasive surgery. Objective: We aim to treat TMD of muscular origin using Botulinum toxin injections in the trigger points. Methods: Patients, whose pain originates from trigger points, will be enrolled in this prospective trial. This study will evaluate subjective and objective responses to treatment with botulinum toxin. The pair of masticatory muscles, masseter and temporalis, will be injected with 30 units and 20 units of botulinum toxin, respectively. Subjective outcomes such as pain and orofacial function on a visual analog scale as well as objective outcomes such as maximal interincisal mouth opening, tenderness to palpation to the temporalis and masseter muscles, maximal bite force measured by electromyogram and the reduction in muscle bulk due to muscle disuse atrophy will be assessed. Expected Results: We expect trigger points in these patients to disappear and the associated muscles to become partially paralyzed and relaxed. Consequently, we expect that the TMJ loading will be reduced and that the patient's overall functional ability will increase. We also expect that muscular hypertrophy volume from hyperactivity will decrease due to disuse atrophy and impact their cosmetic image positively. Overall, we hope these changes will result in a reduction in pain and headaches which will consequently improve the participant's diet, nutrition, psychological well being and quality of life.
Timeline
- Start
- 2016-07
- Primary completion
- 2018-07
- Completion
- 2019-06
Publications
- Background Kaplan AS, Assael LA. Temporomandibular disorders: diagnosis and treatment. Philadelphia (PA): W.B. Saunders Company; 1991. p. 522-5.
- Background Travell JG, Simons DG. Myofascial pain and dysfunction: the trigger point manual. Baltimore (MD):Williams & Wilkins; 1983.
- Background Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.
- Background Adler RC, Adachi NY. Physical medicine in the management of myofascial pain and dysfunction: medical management of temporomandibular disorders. Oral Maxillofac Surg Clin North Am 1995;7(1):99-106.
- Background Gangarosa LP, Mahan PE. Pharmacologic management of TMJ-MPDS. Ear Nose Throat J 1982;61:670.
- Background Murphy GJ. Physical medicine modalities and trigger point injections in the management of temporomandibular disorders and assessing treatment outcome. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997 Jan;83(1):118-22. doi: 10.1016/s1079-2104(97)90101-3.
- Background Syrop S. Pharmacologic management of myofascial pain and dysfunction.Oral Maxillofac Surg Clin North Am 1995;7:87-97.
- Background Dimitroulis G, Gremillion HA, Dolwick MF, Walter JH. Temporomandibular disorders. 2. Non-surgical treatment. Aust Dent J. 1995 Dec;40(6):372-6. doi: 10.1111/j.1834-7819.1995.tb04835.x.
- Background Yoshida H, Fukumura Y, Fujita S, Nishida M, Iizuka T. The expression of cyclooxygenase-2 in human temporomandibular joint samples: an immunohistochemical study. J Oral Rehabil. 2002 Dec;29(12):1146-52. doi: 10.1046/j.1365-2842.2002.00969.x.
- Background Quinn JH, Kent JH, Moise A, Lukiw WJ. Cyclooxygenase-2 in synovial tissue and fluid of dysfunctional temporomandibular joints with internal derangement. J Oral Maxillofac Surg. 2000 Nov;58(11):1229-32; discussion 1232-3. doi: 10.1053/joms.2000.16619.
- Background Israel HA, Syrop SB. The important role of motion in the rehabilitation of patients with mandibular hypomobility: a review of the literature. Cranio. 1997 Jan;15(1):74-83. doi: 10.1080/08869634.1997.11745995.
- Background Karlis V, Andreopoulos N, Kinney L, Glickman R. Effectiveness of supervised calibrated exercise therapy on jaw mobility and temporomandibular dysfunction. J Oral Maxillofac Surg 1994;52(8 Suppl 2):147.
- Background Sebastian MH, Moffett BC. The effects of continuous passive motion on the temporomandibular joint after surgery. Part II. Appliance improvement, normal subject evaluation, pilot clinical trial. Oral Surg Oral Med Oral Pathol. 1989 Jun;67(6):644-53. doi: 10.1016/0030-4220(89)90002-9.
- Background Maloney GE, Mehta N, Forgione AG, Zawawi KH, Al-Badawi EA, Driscoll SE. Effect of a passive jaw motion device on pain and range of motion in TMD patients not responding to flat plane intraoral appliances. Cranio. 2002 Jan;20(1):55-66. doi: 10.1080/08869634.2002.11746191.
- Background Yuasa H, Kurita K; Treatment Group on Temporomandibular Disorders. Randomized clinical trial of primary treatment for temporomandibular joint disk displacement without reduction and without osseous changes: a combination of NSAIDs and mouth-opening exercise versus no treatment. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2001 Jun;91(6):671-5. doi: 10.1067/moe.2001.114005.
- Background Moses JJ, Sartoris D, Glass R, Tanaka T, Poker I. The effect of arthroscopic surgical lysis and lavage of the superior joint space on TMJ disc position and mobility. J Oral Maxillofac Surg. 1989 Jul;47(7):674-8. doi: 10.1016/s0278-2391(89)80004-7.
- Background Nelson SJ, Ash MM Jr. An evaluation of a moist heating pad for the treatment of TMJ/muscle pain dysfunction. Cranio. 1988 Oct;6(4):355-9. doi: 10.1080/08869634.1988.11678261. No abstract available.
- Background Matsumura WM. Use of acupressure techniques and concepts for nonsurgical management of TMJ disorders. J Gen Orthod. 1993 Mar;4(1):5-16. No abstract available.
- Background Elsharkawy TM, Ali NM. Evaluation of acupuncture and occlusal splint therapy in the treatment of temporomandibular joint disorders. Egypt Dent J. 1995 Jul;41(3):1227-32.
- Background Berry H, Fernandes L, Bloom B, Clark RJ, Hamilton EB. Clinical study comparing acupuncture, physiotherapy, injection and oral anti-inflammatory therapy in shoulder-cuff lesions. Curr Med Res Opin. 1980;7(2):121-6. doi: 10.1185/03007998009112038.
- Background Okeson JP, Kemper JT, Moody PM. A study of the use of occlusion splints in the treatment of acute and chronic patients with craniomandibular disorders. J Prosthet Dent. 1982 Dec;48(6):708-12. doi: 10.1016/s0022-3913(82)80034-6.
- Background Okeson JP, Moody PM, Kemper JT, Haley JV. Evaluation of occlusal splint therapy and relaxation procedures in patients with temporomandibular disorders. J Am Dent Assoc. 1983 Sep;107(3):420-4. doi: 10.14219/jada.archive.1983.0275.
- Background Clark GT. A critical evaluation of orthopedic interocclusal appliance therapy: design, theory, and overall effectiveness. J Am Dent Assoc. 1984 Mar;108(3):359-64. doi: 10.14219/jada.archive.1984.0010.
- Background Rugh JD, Harlan J. Nocturnal bruxism and temporomandibular disorders. Adv Neurol. 1988;49:329-41.
- Background Okeson JP. Occlusal appliance therapy. In: Duncan LL, editor. Management of temporomandibular disorders and occlusion. 4th ed. Philadelphia (PA): Mosby Publishing; 1998. p. 474-502.
- Background Major PW, Nebbe B. Use and effectiveness of splint appliance therapy: review of literature. Cranio. 1997 Apr;15(2):159-66. doi: 10.1080/08869634.1997.11746007.
- Background Nitzan DW, Price A. The use of arthrocentesis for the treatment of osteoarthritic temporomandibular joints. J Oral Maxillofac Surg. 2001 Oct;59(10):1154-9; discussion 1160. doi: 10.1053/joms.2001.26716.
- Background Bronstein SL, Thomas M. Arthroscopy of the temporomandibular joint. Philadelphia (PA):W.B. Saunders Co.; 1991. p. 320.
- Background Goss AN, Bosanquet AG. Temporomandibular joint arthroscopy. J Oral Maxillofac Surg. 1986 Aug;44(8):614-7. doi: 10.1016/s0278-2391(86)80072-6.
- Background Sanders B, Buoncristiani R. Diagnostic and surgical arthroscopy of the temporomandibular joint: clinical experience with 137 procedures over a 2-year period. J Craniomandib Disord. 1987 Fall;1(3):202-13. No abstract available.
- Background Holmlund A, Hellsing G. Arthroscopy of the temporomandibular joint. An autopsy study. Int J Oral Surg. 1985 Apr;14(2):169-75. doi: 10.1016/s0300-9785(85)80089-2.
- Background Ohnishi M. Clinical application of arthroscopy in the temporomandibular joint diseases. Bull Tokyo Med Dent Univ. 1980 Sep;27(3):141-50.
- Background Onishi M. [Arthroscopy of the temporomandibular joint (author's transl)]. Kokubyo Gakkai Zasshi. 1975 Jun;42(2):207-13. No abstract available. Japanese.
- Background Dolwick MF, Riggs RR. Diagnosis and treatment of internal derangements of the temporomandibular joint. Dent Clin North Am. 1983 Jul;27(3):561-72. No abstract available.
- Background McCarty WL, Farrar WB. Surgery for internal derangements of the temporomandibular joint. J Prosthet Dent. 1979 Aug;42(2):191-6. doi: 10.1016/0022-3913(79)90174-4.
- Background Moses JJ, Poker ID. TMJ arthroscopic surgery: an analysis of 237 patients. J Oral Maxillofac Surg. 1989 Aug;47(8):790-4. doi: 10.1016/s0278-2391(89)80035-7.
- Background Moses JJ, Lo HH, Lee J, Topper DC. Tomographic changes in the temporomandibular joint following arthroscopic surgery with lysis and lavage and eminentia release. J Orofac Pain. 1994 Fall;8(4):407-12.
- Background Walker RV, Kalamchi S. A surgical technique for management of internal derangement of the temporomandibular joint. J Oral Maxillofac Surg. 1987 Apr;45(4):299-305. doi: 10.1016/0278-2391(87)90347-8.
- Background Hall MB. Meniscoplasty of the displaced temporomandibular joint meniscus without violating the inferior joint space. J Oral Maxillofac Surg. 1984 Dec;42(12):788-92. doi: 10.1016/0278-2391(84)90346-x.
- Background Weinberg S. Eminectomy and meniscorhaphy for internal derangements of the temporomandibular joint. Rationale and operative technique. Oral Surg Oral Med Oral Pathol. 1984 Mar;57(3):241-9. doi: 10.1016/0030-4220(84)90177-4.
- Background Eriksson L, Westesson PL. Diskectomy in the treatment of anterior disk displacement of the temporomandibular joint. A clinical and radiologic one-year follow-up study. J Prosthet Dent. 1986 Jan;55(1):106-16. doi: 10.1016/0022-3913(86)90085-5. No abstract available.
- Background Kondoh T, Hamada Y, Kamei K, Seto K. Simple disc reshaping surgery for internal derangement of the temporomandibular joint: 5-year follow-up results. J Oral Maxillofac Surg. 2003 Jan;61(1):41-8; discussion 48. doi: 10.1053/joms.2003.50007.
- Background Zenz M, Strumpf M, Tryba M. Long-term oral opioid therapy in patients with chronic nonmalignant pain. J Pain Symptom Manage. 1992 Feb;7(2):69-77. doi: 10.1016/0885-3924(92)90116-y.
- Background Zuniga JR. The use of nonopioid drugs in management of chronic orofacial pain. J Oral Maxillofac Surg. 1998 Sep;56(9):1075-80. doi: 10.1016/s0278-2391(98)90260-9.
- Background Tan EK, Jankovic J. Treating severe bruxism with botulinum toxin. J Am Dent Assoc. 2000 Feb;131(2):211-6. doi: 10.14219/jada.archive.2000.0149.
- Background Freund B, Schwartz M, Symington JM. Botulinum toxin: new treatment for temporomandibular disorders. Br J Oral Maxillofac Surg. 2000 Oct;38(5):466-71. doi: 10.1054/bjom.1999.0238.
- Background Freund B, Schwartz M. The use of botulinum toxin for the treatment of temporomandibular disorder. Oral Health. 1998 Feb;88(2):32-7. No abstract available.
- Background Borodic GE, Acquadro MA. The use of botulinum toxin for the treatment of chronic facial pain. J Pain. 2002 Feb;3(1):21-7. doi: 10.1054/jpai.2002.27142.
- Background Ziegler CM, Haag C, Muhling J. Treatment of recurrent temporomandibular joint dislocation with intramuscular botulinum toxin injection. Clin Oral Investig. 2003 Mar;7(1):52-5. doi: 10.1007/s00784-002-0187-y. Epub 2003 Jan 25.
- Background Karacalar A, Yilmaz N, Bilgici A, Bas B, Akan H. Botulinum toxin for the treatment of temporomandibular joint disk disfigurement: clinical experience. J Craniofac Surg. 2005 May;16(3):476-81. doi: 10.1097/04.scs.0000157263.73768.64.
- Background Freund BJ, Schwartz M. Relief of tension-type headache symptoms in subjects with temporomandibular disorders treated with botulinum toxin-A. Headache. 2002 Nov-Dec;42(10):1033-7. doi: 10.1046/j.1526-4610.2002.02234.x.
- Background von Lindern JJ, Niederhagen B, Berge S, Appel T. Type A botulinum toxin in the treatment of chronic facial pain associated with masticatory hyperactivity. J Oral Maxillofac Surg. 2003 Jul;61(7):774-8. doi: 10.1016/s0278-2391(03)00153-8.
- Background von Lindern JJ. Type A botulinum toxin in the treatment of chronic facial pain associated with temporo-mandibular dysfunction. Acta Neurol Belg. 2001 Mar;101(1):39-41.
- Background Cote TR, Mohan AK, Polder JA, Walton MK, Braun MM. Botulinum toxin type A injections: adverse events reported to the US Food and Drug Administration in therapeutic and cosmetic cases. J Am Acad Dermatol. 2005 Sep;53(3):407-15. doi: 10.1016/j.jaad.2005.06.011.
- Background Kocs D, Fendrick AM. Effect of off-label use of oncology drugs on pharmaceutical costs: the rituximab experience. Am J Manag Care. 2003 May;9(5):393-400; quiz 401-2.
- Background Stone KJ, Viera AJ, Parman CL. Off-label applications for SSRIs. Am Fam Physician. 2003 Aug 1;68(3):498-504.
- Background Off-label use of tumor necrosis factor inhibitors on ankylosing spondylitis, ulcerative colitis, and psoriasis. TEC Bull (Online). 2003 Jun 3;20(2):9-18. No abstract available.
- Background Kim HJ, Yum KW, Lee SS, Heo MS, Seo K. Effects of botulinum toxin type A on bilateral masseteric hypertrophy evaluated with computed tomographic measurement. Dermatol Surg. 2003 May;29(5):484-9. doi: 10.1046/j.1524-4725.2003.29117.x.
- Background Ihde SK, Konstantinovic VS. The therapeutic use of botulinum toxin in cervical and maxillofacial conditions: an evidence-based review. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Aug;104(2):e1-11. doi: 10.1016/j.tripleo.2007.02.004. Epub 2007 Jun 7.
- Background Umstadt HE. [Botulinum toxin in oromaxillofacial surgery]. Mund Kiefer Gesichtschir. 2002 Jul;6(4):249-60. doi: 10.1007/s10006-002-0390-7. German.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 20 iu | Intramuscular |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 30 iu | Intramuscular |