NCT01800279

Physiotherapy and Deontology in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome.

Comparative Study on the Effectiveness of Physical Therapy and Deontology for Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Universidad de Almeria · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether kinesitherapy techniques and a myofascial therapy protocol are effective in the treatment of temporomandibular joint dysfunction in patients with fibromyalgia syndrome.

Detailed description

Design: randomized clinical trial. Objective: to compare the therapeutic effects of physiotherapy and deontology protocol to improve pain, quality of life, physical function, quality of sleep, depression, anxiety, clinical severity, clinical improvement, and diagnostic criteria for research temporomandibular joint dysfunction in patients with fibromyalgia syndrome (FMS). 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

• Temporomandibular Joint Dysfunction Syndrome

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-02-27
• Last updated: 2013-12-11

Locations

1 site across 1 country: Spain