Benefits of a Multidisciplinary Therapy in the Temporomandibular Joint Dysfunction in Patients With Fibromyalgia Syndrome: a Randomized Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Temporomandibular Joint Dysfunction Syndrome
- Sponsor
- Universidad de Almeria
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Change on pain intensity
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Adelaida María Castro-Sánchez
PhD (Lecturer)
Universidad de Almeria
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.
Outcomes
Primary Outcomes
Change on pain intensity
Time Frame: At baseline, 15 weeks and 20 weeks
The visual analog scales designed to measure the intensity of pain and degree of relief experienced by the patient; with the value 0 refers to the situation of no pain and score 100 refers to the situation of unbearable pain.
Secondary Outcomes
- Change in temporomandibular dysfunction(At baseline, 15 weeks and 20 weeks)
- Change in quality of life SF-36(At baseline, 15 weeks and 20 weeks)
- Change on quality of sleep(At baseline, 15 weeks and 20 weeks)
- Change on rates of depression(At baseline, 15 weeks and 20 weeks)
- Change on state-trait anxiety(At baseline, 15 weeks and 20 weeks)
- Change on index of widespread pain and symptom severity(At baseline, 15 weeks and 20 weeks)
- Change in physical function(At baseline, 15 weeks and 20 weeks)