Use of TENS for the Recovery of Oral Function After Orthognathic Surgery
NCT ID: NCT05362383
Last Updated: 2022-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
47 participants
INTERVENTIONAL
2013-02-01
2020-01-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental group
transcutaneous electrical nerve stimulation (TENS) is applied
transcutaneous electrical nerve stimulation (TENS):Enraf Nonius® S82 model
Will be used TENS device with a maximum frequency of 120 Hz and an intensity range of 0 to 99.5 milliampere. TENS electrodes (diameter 35-52 mm) will be placed bilaterally on mandibular elevator muscles, on the superficial masseter muscle above the gonial angle, and bilaterally on the anterior temporal muscle. The device will be applied in an identical manner to all patients in both groups and kept in position for the same time period (30 min) and for the control group the the device will be not switched on
Control group
no intervention
No interventions assigned to this group
Interventions
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transcutaneous electrical nerve stimulation (TENS):Enraf Nonius® S82 model
Will be used TENS device with a maximum frequency of 120 Hz and an intensity range of 0 to 99.5 milliampere. TENS electrodes (diameter 35-52 mm) will be placed bilaterally on mandibular elevator muscles, on the superficial masseter muscle above the gonial angle, and bilaterally on the anterior temporal muscle. The device will be applied in an identical manner to all patients in both groups and kept in position for the same time period (30 min) and for the control group the the device will be not switched on
Eligibility Criteria
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Inclusion Criteria
* no previous or concomitant surgery for temporo-mandibular disorders
* no presence of complex syndromes
* no presence of muscle or nervous disorders or receipt of medication for such disorders
Exclusion Criteria
* refusal of informed consent
22 Years
65 Years
ALL
No
Sponsors
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Universidad Complutense de Madrid
OTHER
Responsible Party
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Alberto Cacho Casado
Associate Professor and Department Chair, Department of Dental Clinical Specialties, Faculty of Odontology, Complutense University, Madrid, Spain
Principal Investigators
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Alberto C Cacho, Prof
Role: PRINCIPAL_INVESTIGATOR
Faculty of Odontology, University Complutense, Madrid
Locations
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Faculty of Odontology, University Complutense
Madrid, , Spain
Countries
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References
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Teng TT, Ko EW, Huang CS, Chen YR. The Effect of early physiotherapy on the recovery of mandibular function after orthognathic surgery for Class III correction: part I--jaw-motion analysis. J Craniomaxillofac Surg. 2015 Jan;43(1):131-7. doi: 10.1016/j.jcms.2014.10.025. Epub 2014 Nov 1.
Wen-Ching Ko E, Huang CS, Lo LJ, Chen YR. Longitudinal observation of mandibular motion pattern in patients with skeletal Class III malocclusion subsequent to orthognathic surgery. J Oral Maxillofac Surg. 2012 Feb;70(2):e158-68. doi: 10.1016/j.joms.2011.10.002.
Jung HD, Jung YS, Park JH, Park HS. Recovery pattern of mandibular movement by active physical therapy after bilateral transoral vertical ramus osteotomy. J Oral Maxillofac Surg. 2012 Jul;70(7):e431-7. doi: 10.1016/j.joms.2012.02.033.
Bell WH, Gonyea W, Finn RA, Storum KA, Johnston C, Throckmorton GS. Muscular rehabilitation after orthognathic surgery. Oral Surg Oral Med Oral Pathol. 1983 Sep;56(3):229-35. doi: 10.1016/0030-4220(83)90001-4.
Oh DW, Kim KS, Lee GW. The effect of physiotherapy on post-temporomandibular joint surgery patients. J Oral Rehabil. 2002 May;29(5):441-6. doi: 10.1046/j.1365-2842.2002.00850.x.
Dailey DL, Rakel BA, Vance CGT, Liebano RE, Amrit AS, Bush HM, Lee KS, Lee JE, Sluka KA. Transcutaneous electrical nerve stimulation reduces pain, fatigue and hyperalgesia while restoring central inhibition in primary fibromyalgia. Pain. 2013 Nov;154(11):2554-2562. doi: 10.1016/j.pain.2013.07.043. Epub 2013 Jul 27.
Sato KL, Sanada LS, Rakel BA, Sluka KA. Increasing intensity of TENS prevents analgesic tolerance in rats. J Pain. 2012 Sep;13(9):884-90. doi: 10.1016/j.jpain.2012.06.004. Epub 2012 Aug 1.
Dowswell T, Bedwell C, Lavender T, Neilson JP. Transcutaneous electrical nerve stimulation (TENS) for pain relief in labour. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007214. doi: 10.1002/14651858.CD007214.pub2.
Tong KC, Lo SK, Cheing GL. Alternating frequencies of transcutaneous electric nerve stimulation: does it produce greater analgesic effects on mechanical and thermal pain thresholds? Arch Phys Med Rehabil. 2007 Oct;88(10):1344-9. doi: 10.1016/j.apmr.2007.07.017.
Liebano RE, Rakel B, Vance CGT, Walsh DM, Sluka KA. An investigation of the development of analgesic tolerance to TENS in humans. Pain. 2011 Feb;152(2):335-342. doi: 10.1016/j.pain.2010.10.040. Epub 2010 Dec 8.
Mendell LM. Constructing and deconstructing the gate theory of pain. Pain. 2014 Feb;155(2):210-216. doi: 10.1016/j.pain.2013.12.010. Epub 2013 Dec 12.
Iwase M, Ohashi M, Tachibana H, Toyoshima T, Nagumo M. Bite force, occlusal contact area and masticatory efficiency before and after orthognathic surgical correction of mandibular prognathism. Int J Oral Maxillofac Surg. 2006 Dec;35(12):1102-7. doi: 10.1016/j.ijom.2006.08.014. Epub 2006 Nov 9.
Hidaka O, Iwasaki M, Saito M, Morimoto T. Influence of clenching intensity on bite force balance, occlusal contact area, and average bite pressure. J Dent Res. 1999 Jul;78(7):1336-44. doi: 10.1177/00220345990780070801.
Matsui Y, Ohno K, Michi K, Suzuki Y, Yamagata K. A computerized method for evaluating balance of occlusal load. J Oral Rehabil. 1996 Aug;23(8):530-5. doi: 10.1111/j.1365-2842.1996.tb00891.x.
Ohkura K, Harada K, Morishima S, Enomoto S. Changes in bite force and occlusal contact area after orthognathic surgery for correction of mandibular prognathism. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2001 Feb;91(2):141-5. doi: 10.1067/moe.2001.112334.
Yaedu RYF, Mello MAB, Tucunduva RA, da Silveira JSZ, Takahashi MPMS, Valente ACB. Postoperative Orthognathic Surgery Edema Assessment With and Without Manual Lymphatic Drainage. J Craniofac Surg. 2017 Oct;28(7):1816-1820. doi: 10.1097/SCS.0000000000003850.
Moran F, Leonard T, Hawthorne S, Hughes CM, McCrum-Gardner E, Johnson MI, Rakel BA, Sluka KA, Walsh DM. Hypoalgesia in response to transcutaneous electrical nerve stimulation (TENS) depends on stimulation intensity. J Pain. 2011 Aug;12(8):929-35. doi: 10.1016/j.jpain.2011.02.352. Epub 2011 Apr 9.
Throckmorton GS, Ellis E 3rd, Buschang PH. Morphologic and biomechanical correlates with maximum bite forces in orthognathic surgery patients. J Oral Maxillofac Surg. 2000 May;58(5):515-24. doi: 10.1016/s0278-2391(00)90014-4.
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Nagai I, Tanaka N, Noguchi M, Suda Y, Sonoda T, Kohama G. Changes in occlusal state of patients with mandibular prognathism after orthognathic surgery: a pilot study. Br J Oral Maxillofac Surg. 2001 Dec;39(6):429-33. doi: 10.1054/bjom.2001.0681.
Ueki K, Marukawa K, Hashiba Y, Nakagawa K, Degerliyurt K, Yamamoto E. Assessment of the relationship between the recovery of maximum mandibular opening and the maxillomandibular fixation period after orthognathic surgery. J Oral Maxillofac Surg. 2008 Mar;66(3):486-91. doi: 10.1016/j.joms.2007.08.044.
Oliveira Sierra S, Melo Deana A, Mesquita Ferrari RA, Maia Albarello P, Bussadori SK, Santos Fernandes KP. Effect of low-level laser therapy on the post-surgical inflammatory process after third molar removal: study protocol for a double-blind randomized controlled trial. Trials. 2013 Nov 6;14:373. doi: 10.1186/1745-6215-14-373.
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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C.P. - C.I. 12/136-E
Identifier Type: -
Identifier Source: org_study_id
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