Multidisciplinary Therapy in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome

Universidad de Almeria

Status: Completed

Conditions: Temporomandibular Joint Dysfunction Syndrome

Treatments: Other: Placebo; Other: Multidisciplinary therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01825629

UAL-321-15/03/2013

Details and patient eligibility

About

The purpose of this study is to determine the efficacy of a multidisciplinary therapy with physical, manual and deontology therapies 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 physical therapy, manual therapy and deontology therapy to improve pain, quality of life, physical function, quality of sleep, depression, anxiety, clinical severity, clinical improvement, and temporomandibular dysfunction in patients with fibromyalgia syndrome.

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.

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, including a placebo group

Multidisplinary Therapy

Experimental group

Description:

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.

Treatment:

Other: Multidisciplinary therapy

One technique of myofascial release

Placebo Comparator group

Description:

A physiotherapist administered 15 sessions of "induction occipital" once a week.

Treatment:

Other: Placebo