Multidisciplinary Therapy in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome
NCT ID: NCT01825629
Last Updated: 2013-12-11
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
70 participants
INTERVENTIONAL
2013-04-30
2013-12-31
Brief Summary
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Detailed Description
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Methods and measures: seventy patients will be randomly assigned to experimental or placebo control group. The experimental group will receive 30 sessions (twice a weeks) of physical therapy, manual therapy and deontology therapy. Pain intensity, impact of fibromyalgia symptoms, quality of sleep, depression, anxiety, clinical severity, clinical improvement and temporomandibular dysfunction will be collected in both groups al baseline, 15 weeks and 20 weeks after 48-hr the last intervention in the experimental and placebo control groups, by an assessor blinded to the treatment allocation of the patients. Baseline demographic and clinical variables will be examined between both groups with independent Student t-test for continuous data and chi-square tests of independence for categorical data. Separate 2x3 model ANOVA with time (baseline, 15 weeks and 20 weeks) as the within-subjects factor, group (experimental, placebo control) will be determine the effects of the multidisciplinary treatment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Multidisplinary Therapy
The multidisciplinary therapy involves the application of physical therapy, manual therapy and deontology therapy. This multidisciplinary therapy will be administered twice a week for 15 weeks.
Multidisciplinary therapy
Physical Therapy: Cervical traction, Cranium fore flexion 15 °, Open-close mouth dental contactless (10 mm), Opening movement with a small resistor (one finger on chin), Flexion of the head, without actually lifting, resisting in the front, Occipital extension, Cranium fore flexion 15 °, Cervical traction.
Myofascial Therapy: Induction suboccipital, compression - decompression of the temporomandibular joint, horizontal induction of the temporomandibular joint, deep fascia induction in the temporal region, deep induction of the masseter fascia, deep induction of the external pterygoid, and induction of intraoral pterygoid.
Deontology therapy: the patient are going to port a deprogramming occlusal splint every night, an average of 8 hours per day, for 15 weeks.
One technique of myofascial release
A physiotherapist administered 15 sessions of "induction occipital" once a week.
Placebo
Interventions
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Multidisciplinary therapy
Physical Therapy: Cervical traction, Cranium fore flexion 15 °, Open-close mouth dental contactless (10 mm), Opening movement with a small resistor (one finger on chin), Flexion of the head, without actually lifting, resisting in the front, Occipital extension, Cranium fore flexion 15 °, Cervical traction.
Myofascial Therapy: Induction suboccipital, compression - decompression of the temporomandibular joint, horizontal induction of the temporomandibular joint, deep fascia induction in the temporal region, deep induction of the masseter fascia, deep induction of the external pterygoid, and induction of intraoral pterygoid.
Deontology therapy: the patient are going to port a deprogramming occlusal splint every night, an average of 8 hours per day, for 15 weeks.
Placebo
Eligibility Criteria
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Inclusion Criteria
* Agreement to attend evening therapy sessions
* A chief complaint of acute pain (duration \< 6 months) in the temporomandibular joint on at least one side.
* The presence of joint clicking during jaw opening that was eliminated on protrusive opening.
Exclusion Criteria
* Therapeutic co-interventions during treatment.
* Indication for surgical treatment of temporomandibular joint.
* Edentulism.
* Physical or mental illness that precludes attendance at therapy sessions.
30 Years
65 Years
ALL
No
Sponsors
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Universidad de Granada
OTHER
Universidad de Almeria
OTHER
Responsible Party
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Adelaida María Castro-Sánchez
PhD (Lecturer)
Principal Investigators
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Adelaida M Castro-Sánchez, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad de Almeria
Locations
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Fibromyalgia Association (AGRAFIM)
Granada, Almeria, Spain
Countries
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References
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Fernandez-Carnero J, La Touche R, Ortega-Santiago R, Galan-del-Rio F, Pesquera J, Ge HY, Fernandez-de-Las-Penas C. Short-term effects of dry needling of active myofascial trigger points in the masseter muscle in patients with temporomandibular disorders. J Orofac Pain. 2010 Winter;24(1):106-12.
Fricton JR, Ouyang W, Nixdorf DR, Schiffman EL, Velly AM, Look JO. Critical appraisal of methods used in randomized controlled trials of treatments for temporomandibular disorders. J Orofac Pain. 2010 Spring;24(2):139-51.
Oliveira-Campelo NM, Rubens-Rebelatto J, Marti N-Vallejo FJ, Alburquerque-Sendi N F, Fernandez-de-Las-Penas C. The immediate effects of atlanto-occipital joint manipulation and suboccipital muscle inhibition technique on active mouth opening and pressure pain sensitivity over latent myofascial trigger points in the masticatory muscles. J Orthop Sports Phys Ther. 2010 May;40(5):310-7. doi: 10.2519/jospt.2010.3257.
Santos Tde S, Piva MR, Ribeiro MH, Antunes AA, Melo AR, Silva ED. Lasertherapy efficacy in temporomandibular disorders: control study. Braz J Otorhinolaryngol. 2010 May-Jun;76(3):294-9. doi: 10.1590/S1808-86942010000300004.
La Touche R, Paris-Alemany A, von Piekartz H, Mannheimer JS, Fernandez-Carnero J, Rocabado M. The influence of cranio-cervical posture on maximal mouth opening and pressure pain threshold in patients with myofascial temporomandibular pain disorders. Clin J Pain. 2011 Jan;27(1):48-55. doi: 10.1097/AJP.0b013e3181edc157.
Silant'eva EN. [The role of therapeutic exercises in the combined treatment and rehabilitation of patients with pain syndrome associated with the dysfunction of temporomandibular joint]. Vopr Kurortol Fizioter Lech Fiz Kult. 2010 May-Jun;(3):22-6. Russian.
Ariji Y, Katsumata A, Hiraiwa Y, Izumi M, Sakuma S, Shimizu M, Kurita K, Ariji E. Masseter muscle sonographic features as indices for evaluating efficacy of massage treatment. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Oct;110(4):517-26. doi: 10.1016/j.tripleo.2010.05.003.
Miernik M, Wieckiewicz M, Paradowska A, Wieckiewicz W. Massage therapy in myofascial TMD pain management. Adv Clin Exp Med. 2012 Sep-Oct;21(5):681-5.
de Felicio CM, Medeiros AP, de Oliveira Melchior M. Validity of the 'protocol of oro-facial myofunctional evaluation with scores' for young and adult subjects. J Oral Rehabil. 2012 Oct;39(10):744-53. doi: 10.1111/j.1365-2842.2012.02336.x. Epub 2012 Aug 1.
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Manfredini D, Castroflorio T, Perinetti G, Guarda-Nardini L. Dental occlusion, body posture and temporomandibular disorders: where we are now and where we are heading for. J Oral Rehabil. 2012 Jun;39(6):463-71. doi: 10.1111/j.1365-2842.2012.02291.x. Epub 2012 Mar 21.
Aggarwal A, Keluskar V. Physiotherapy as an adjuvant therapy for treatment of TMJ disorders. Gen Dent. 2012 Mar-Apr;60(2):e119-22.
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Doepel M, Nilner M, Ekberg E, LE Bell Y. Long-term effectiveness of a prefabricated oral appliance for myofascial pain. J Oral Rehabil. 2012 Apr;39(4):252-60. doi: 10.1111/j.1365-2842.2011.02261.x. Epub 2011 Oct 11.
Hunter EK. Integration of rehabilitation and acupuncture in the treatment of a professional musician with temporomandibular joint dysfunction. Acupunct Med. 2011 Dec;29(4):298-301. doi: 10.1136/aim.2010.003889. Epub 2011 Jun 16.
Armijo-Olivo S, Silvestre R, Fuentes J, da Costa BR, Gadotti IC, Warren S, Major PW, Thie NM, Magee DJ. Electromyographic activity of the cervical flexor muscles in patients with temporomandibular disorders while performing the craniocervical flexion test: a cross-sectional study. Phys Ther. 2011 Aug;91(8):1184-97. doi: 10.2522/ptj.20100233. Epub 2011 Jun 9.
Cuccia AM, Caradonna C, Caradonna D. Manual therapy of the mandibular accessory ligaments for the management of temporomandibular joint disorders. J Am Osteopath Assoc. 2011 Feb;111(2):102-12.
Other Identifiers
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UAL-321-15/03/2013
Identifier Type: -
Identifier Source: org_study_id