Completed

Benefits of a Multidisciplinary Therapy in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome: a Randomized Clinical Trial

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What is being tested

Multidisciplinary therapy

+ Placebo

Other
Who is being recruted

Jaw Diseases+15

+ Joint Diseases

+ Mandibular Diseases

From 30 to 65 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorUniversidad de Almeria
Last updated: December 11, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversidad de Almeria
Last updated: December 11, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

70 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Jaw DiseasesJoint DiseasesMandibular DiseasesStomatognathic DiseasesMuscular DiseasesMusculoskeletal DiseasesMyofascial Pain SyndromesNervous System DiseasesNeurologic ManifestationsNeuromuscular DiseasesRheumatic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsTemporomandibular Joint DisordersCraniomandibular DisordersFibromyalgiaPainTemporomandibular Joint Dysfunction Syndrome

Criteria

4 inclusion criteria required to participate
A chief complaint of acute pain (duration < 6 months) in the temporomandibular joint on at least one side

Agreement to attend evening therapy sessions

Diagnosis of Fibromyalgia Syndrome

The presence of joint clicking during jaw opening that was eliminated on protrusive opening

5 exclusion criteria prevent from participating
Edentulism

History of recent trauma

Indication for surgical treatment of temporomandibular joint

Physical or mental illness that precludes attendance at therapy sessions

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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.

Group II

Placebo
A physiotherapist administered 15 sessions of &quot;induction occipital&quot; once a week.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Fibromyalgia Association (AGRAFIM)

Granada, SpainOpen Fibromyalgia Association (AGRAFIM) in Google Maps
CompletedOne Study Center