Physiotherapy and Deontology in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome.
NCT ID: NCT01800279
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
2013-03-31
2013-12-31
Brief Summary
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Detailed Description
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Background: the results on physiotherapy benefits for temporomandibular joint dysfunction in patients with FMS are controversial. Descriptive data and intervention studies are still scarce.
Methods and measures: sixty patients will be randomly assigned to experimental or control group. The experimental group will receive 24 sessions (twice a week) of kinesitherapy and myofascial release protocol, whereas the control group will undergo to deontology therapy (porting a deprogramming occlusal splint every night, an average of 8 hours per day, for 12 weeks of the treatment). Pain levels, impact of FMS symptoms, quality of sleep, depression, anxiety, clinical severity, clinical improvement and diagnostic criteria for research of temporomandibular joint dysfunction will be collected in both groups at baseline and 12 weeks after 48-hr the last intervention in the experimental and control groups, by an assessor blinded to the treatment allocation of the patients. Baseline demographic and clinical variables will be examined between both groups independent Student t-test for continuous data and χ2 tests of independence for categorical data. Separate 2x2 mixed model ANCOVAs with time (pre-post) as the within-subjects factor, group (experimental, control) will be to determine the effects of the treatment on pain, function, quality of sleep,depression, anxiety, clinical severity, clinical improvement and diagnostic criteria for research of temporomandibular joint dysfunction as the dependent variables.
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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Deontology Therapy
The patients in the control group will port a deprogramming occlusal splint to sleep every night, an average of 8 hours per day, for 12 weeks of the treatment.
Deontology Therapy
For the realization of the splint, the following protocol will be developed at the Faculty of Dentistry of Granada (Spain):
* Impression of the maxilla with chromatic alginate "Phase plus" (Zhermack ©, Rovigo, Italy).
* Emptying working models in plaster-stone type IV "Elite Rock" (Zhermack ©, Rovigo, Italy).
* Deprogramming occlusal splints were made of polyester plates with terephthalic acid of 3 mm thick Clear 120 model (Dentaflux ©, Ripoll, Madrid). We used a molding machine of thermoplastic vacuum plate "The Machine" Dentaflux ©, Ripoll, Madrid.
Physiotherapy Protocol
The physiotherapy protocol involves the application of kinesitherapy techniques and a myofascial therapy protocol. This protocol will be administered twice a week for 12 weeks.
Physiotherapy Protocol
Kinesitherapy
* Patient: supine position on the stretcher with a loop of 6 cm in the cervical area.
* Tongue in the palate for all applied exercises.
* Repetitions of each exercise: 8. Cervical traction. Cranium fore flexion 15 °. Open-close mouth dental contactless (10mm). 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 TMJ (Temporomandibular Joint). Horizontal Induction TMJ. Deep fascia induction in the temporal region. Deep Induction of the masseter fascia. Deep Induction of the external pterygoid. Induction of intraoral pterygoid.
Interventions
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Physiotherapy Protocol
Kinesitherapy
* Patient: supine position on the stretcher with a loop of 6 cm in the cervical area.
* Tongue in the palate for all applied exercises.
* Repetitions of each exercise: 8. Cervical traction. Cranium fore flexion 15 °. Open-close mouth dental contactless (10mm). 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 TMJ (Temporomandibular Joint). Horizontal Induction TMJ. Deep fascia induction in the temporal region. Deep Induction of the masseter fascia. Deep Induction of the external pterygoid. Induction of intraoral pterygoid.
Deontology Therapy
For the realization of the splint, the following protocol will be developed at the Faculty of Dentistry of Granada (Spain):
* Impression of the maxilla with chromatic alginate "Phase plus" (Zhermack ©, Rovigo, Italy).
* Emptying working models in plaster-stone type IV "Elite Rock" (Zhermack ©, Rovigo, Italy).
* Deprogramming occlusal splints were made of polyester plates with terephthalic acid of 3 mm thick Clear 120 model (Dentaflux ©, Ripoll, Madrid). We used a molding machine of thermoplastic vacuum plate "The Machine" Dentaflux ©, Ripoll, Madrid.
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
Andaluz Health Service
OTHER_GOV
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: STUDY_DIRECTOR
Universidad de Almeria
Locations
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Fibromyalgia Association (AGRAFIM)
Granada, Almeria, Spain
Countries
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References
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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.
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Other Identifiers
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UAL-12
Identifier Type: -
Identifier Source: org_study_id