Body Awareness Therapy and Biomarkers in Fibromyalgia

Study Overview
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Brief Summary
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A randomized trial of Basic Body Awareness Therapy (BBAT) is applied in fibromyalgia patients as compared with a control intervention consisting of stretching. Sessions of BBAT lasted 90 min each and took place twice a week form 12 weeks. The primary end point is a change in the biomarkers and neurotransmitters and the Fibromyalgia Impact Questionnaire and the secondary end points include Visual Analog Scale, State Trait Anxiety inventory, Beck Depression Inventory. All assessments will be repeated at post treatment, 12 and 24 weeks and 1 year follow-up.

Detailed Description
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This work is a clinical trial of randomized and controlled groups. The hypothesis of study is that BBAT applied in patients with fibromyalgia improves, more than stretching exercises, the pain, normalization biomarkers, improve in psychological state and quality life. The study population will be selected followed the inclusion criteria of fibromyalgia, and will be selected in Consorci Sociosanitari of Anoia, the patients will be divided in 2 groups, control and treatment group. The groups will be examined at the begin, at 2 weeks, at the end of treatment and 3, 6 and 12 months follow-up. The dependence measurements will be biomarkers serotonin, dopamine and cortisol, also Visual Analog Scale, State Trait Anxiety Inventory (STAI A/R), Beck Depression Inventory (BDI-II) and Fibromyalgia Impact Questionnaire (FIQ). The independence measurements will be demographic items: sex, age, country, level of studies, social status...

Official Title
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Biomarkers Changes in Patients With Fibromyalgia Using Basic Body Awareness Therapy

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Basic Body Awareness Therapy
* Other: Stretching Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: whose diagnosed of fibromyalgia almost 6 months before whose could be in different position such as lying, sitting, and stand-up Exclusion Criteria: whose are diagnosed of disease that it worse the pain pregnancy whose are diagnosed of other disease such as rheumatology, neurology, cardiac problems o another internal medical condition,malignant disease or acute infections

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: clinical trial randomized allocated controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Basic Body Awareness Therapy<br>the Basic Body Awareness Therapy is usual therapy of physiotherapy in mental health in nord europe. BBAT is based in twelve movements and massage that improve the movements quality of patient, also improves other movement qualities like biomechanical, physiologic, socio-cultural and existential | Other: Basic Body Awareness Therapy<br>* The intervention will be twice a week during 12 weeks. It lasts 90 min of movements of daily life, massage and self-reflections.<br>* Other names: BBAT;|
| Active Comparator: Stretching group<br>Stretching exercise will be developed in control group in order to blind the intervention of interest. It will consist in analytic stretching of trunk, upper and lower limb. It will last around 45 min twice a week during 12 weeks. | Other: Stretching Exercise<br>* It consists in stretching movements of whole body<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serotonin | Neurotransmitter neurologic | through study completion, an average of 1 year | 
| cortisol | acute hormone relating stress | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | Assess of subjective pain of patient. It consists in a number between 0 to 10 | through study completion, an average of 1 year | 
| Fibromyalgia Impact Questionnaire (FIQ) | Questionnaire about the impact of symptoms of Fibromyalgia in daily life. It measures 21 items with a total score between 0 to 100. The main average is 50. | through study completion, an average of 1 year | 
| Beck Depression Inventory- II (BDI-II) | Questionnaire for assess the depression of patient. It consists in 21 items with scale ranking from 0-3 with a total score from 0-63. A score between 10-18 corresponds to mild to moderate depression, further than 30 corresponds to severe depression | through study completion, an average of 1 year | 
| State Trait Anxiety Inventory (STAI) | Questionnaire for assess the anxiety of patient. It consists in 20 questions that score range from 20 to 80. The higher scores correlating with greater anxiety. The questionnaire provide information about state (how a person is feeling at the time) and trait (how people feel across typical situations that everyone experiences on a daily basis) | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body awareness therapy, physical therapy, serotonin, cortisol