Clinical trial NCT01825629: Multidisciplinary Therapy in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome
Official title: Benefits of a Multidisciplinary Therapy in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Dysfunction Syndrome
Keywords: Pain
Temporomandibular joint
Manual therapy
Physical therapy
Fibromyalgia Syndrome
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
Collaborators: name: Universidad de Granada
First posted: 2013-04-05
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change on pain intensity
timeFrame: At baseline, 15 weeks and 20 weeks
Secondary outcomes:
measure: Change in temporomandibular dysfunction
timeFrame: At baseline, 15 weeks and 20 weeks
measure: Change in quality of life SF-36
timeFrame: At baseline, 15 weeks and 20 weeks
measure: Change on index of widespread pain and symptom severity
timeFrame: At baseline, 15 weeks and 20 weeks
measure: Change in physical function
timeFrame: At baseline, 15 weeks and 20 weeks
measure: Change on quality of sleep
timeFrame: At baseline, 15 weeks and 20 weeks
measure: Change on rates of depression
timeFrame: At baseline, 15 weeks and 20 weeks
measure: Change on state-trait anxiety
timeFrame: At baseline, 15 weeks and 20 weeks
Other outcomes:
measure: Change in clinical impression of severity
timeFrame: At baseline, 15 weeks and 20 weeks
measure: Change in clinical global impression of improvement
timeFrame: 15 weeks and 20 weeks after intervention
Locations:
city: Granada
country: Spain
facility: Fibromyalgia Association (AGRAFIM)
state: Almeria
Study officials:
affiliation: Universidad de Almeria
name: Adelaida M Castro-Sánchez, PhD
role: PRINCIPAL_INVESTIGATOR
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