Clinical trial NCT01800279: Physiotherapy and Deontology in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome.
Official title: Comparative Study on the Effectiveness of Physical Therapy and Deontology for Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Dysfunction Syndrome
Keywords: Fibromyalgia Syndrome, Temporomandibular Joint, Pain.
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
Collaborators: name: Universidad de Granada
name: Andaluz Health Service
First posted: 2013-02-27
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 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.

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: Pain Intensity
timeFrame: At baseline and 12 weeks
Secondary outcomes:
measure: Temporomandibular Dysfunction.
timeFrame: At baseline and 12 weeks
measure: Quality of Life (SF-36)
timeFrame: At baseline and 12 weeks
measure: Index of Widespread Pain and Symptom Severity
timeFrame: At baseline and 12 weeks
measure: Physical Function.
timeFrame: At baseline and 12 weeks
measure: Quality of Sleep.
timeFrame: At baseline and 12 weeks
measure: Rates of Depression
timeFrame: At baseline and 12 weeks
measure: State-Trait Anxiety.
timeFrame: At baseline and 12 weeks
Other outcomes:
measure: Clinical Impression of Severity.
timeFrame: At baseline and 12 weeks
measure: Clinical Global Impression Improvement.
timeFrame: At baseline and 12 weeks
Locations:
city: Granada
country: Spain
facility: Fibromyalgia Association (AGRAFIM)
state: Almeria
Study officials:
affiliation: Universidad de Almeria
name: Adelaida M Castro-Sánchez, PhD
role: STUDY_DIRECTOR
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