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

Universidad de Almeria

Status: Completed

Conditions: Temporomandibular Joint Dysfunction Syndrome

Treatments: Other: Deontology Therapy; Other: Physiotherapy Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT01800279

UAL-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of fibromyalgia syndrome.
• 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

• History of recent trauma.
• Therapeutic co-interventions during treatment.
• Indication for surgical treatment of temporomandibular joint.
• Edentulism.
• Physical or mental illness that precludes attendance at therapy sessions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Deontology Therapy

Active Comparator group

Description:

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.

Treatment:

Other: Deontology Therapy

Physiotherapy Protocol

Experimental group

Description:

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.

Treatment:

Other: Physiotherapy Protocol