Comparison of the Effects of Face-to-Face and Internet-Based BBAT in Fibromyalgia Syndrome

Study Overview
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Brief Summary
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The aim of our study is to compare the effects of face-to-face and internet-based BBAT in patients diagnosed with Fibromyalgia Syndrome. H0: Face-to-face and internet-based CFT have superiority over each other in patients diagnosed with Fibromyalgia Syndrome. H1: In patients diagnosed with Fibromyalgia Syndrome, face-to-face and internet-based CFT have no superiority over each other.

Detailed Description
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The aim of our study is to compare the effects of face-to-face and internet-based BBAT in patients diagnosed with Fibromyalgia Syndrome. H0: Face-to-face and internet-based CFT have superiority over each other in patients diagnosed with Fibromyalgia Syndrome. H1: In patients diagnosed with Fibromyalgia Syndrome, face-to-face and internet-based CFT have no superiority over each other. Goals: Investigation of the effects of face-to-face and internet-based BBAT on functional disability, pressure pain threshold, body awareness, posture, pain intensity, trunk position sense, postural control, balance, sleep quality, quality of life and inflammation level in patients diagnosed with Fibromyalgia Syndrome. Comparison of the effects of face-to-face and internet-based BBAT on functional disability, pressure pain threshold, body awareness, posture, pain intensity, trunk position sense, postural control, balance, sleep quality, quality of life and inflammation level in patients diagnosed with Fibromyalgia Syndrome

Official Title
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Comparison of the Effects of Face-to-Face and Internet-Based Basic Body Awareness Therapy in Fibromyalgia Syndrome

Conditions
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Fibromyalgia

Intervention / Treatment
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* Behavioral: BBAT (Basic Body Awareness Therapy)
* Behavioral: Online BBAT training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be between the ages of 18-65 Being diagnosed with FMS according to ACR 2010 criteria To be diagnosed with FMS at least 6 months before the study Reported pain intensity > 4 (Visual Analog Scale 0-10), Individuals that do not have barriers to basic body awareness therapy. Exclusion Criteria: Pregnancy or intention to become pregnant within the study period. Substance and alcohol abuse, major psychiatric disorder (preventing compliance), uncontrolled hypertension, diabetes, congestive heart failure, or other serious chronic medical condition that puts the patient at risk for the clinician to expose the patient to potentially serious consequences of their illness Those who have malignancy and those receiving chemotherapy and radiotherapy causing malignancy Those who have suffered from any musculoskeletal, neurological, rheumatological disorder or any condition that may interfere with evaluations (advanced respiratory or orthopedic problems such as fractures, sprains or strains, or spinal surgery) in the past 12 months -

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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The group I: BBAT Face-to-Face Training group<br>Exercises consist of supine, sitting, standing position awareness exercises and walking exercises. Considering eight weeks, the training is designed to progress gradually each week. | Behavioral: BBAT (Basic Body Awareness Therapy)<br>* The group I: BBAT Face-to-Face Training (60 min) will be provided.<br>|
| Experimental: The group II: Online BBAT training group<br>Patients in the Internet-based BFT group will conduct their training with a physiotherapist to be connected via an online video conference system. This group will be given the same training as the face-to-face BFT group. | Behavioral: Online BBAT training<br>* The group II: Online BBAT training (60 min) will be provided.<br>|
| No Intervention: The group III: Control group<br>No training will be applied to the control group patients. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Revised Fibromyalgia Impact Questionnaire (FIQR) | Limitations and functional disability in patients with fibromyalgia will be evaluated. | 8 weeks | 
| Algometer | Pressure pain threshold measurement of characteristic 18 tender points of fibromyalgia syndrome will be performed. | 8 weeks | 
| Awareness-Body-Chart=ABC | Awareness-Body-Chart=ABC will be used to assess body awareness. | 8 weeks | 
| Posture Screen Mobile (PSM) | Posture will be evaluated with Posture Screen Mobile (PSM), an iPad application. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The short-form McGill Pain Questionnaire | Pain will be evaluated with the short-form McGill Pain Questionnaire | 8 weeks | 
| Trunk repositioning error | The trunk position sense indicated by trunk reposition errors will be evaluated with the inclinometer device. | 8 weeks | 
| Postural stability | Postural stability will be evaluated with a portable force platform. | 8 weeks | 
| Single Leg Balance | Balance will be evaluated with the single leg balance test with eyes open and closed. | 8 weeks | 
| Pittsburgh Sleep Quality Index | Sleep quality will be assessed by the Pittsburgh Sleep Quality Index. | 8 weeks | 
| SF-36 (the MOS 36-item short-form health survey) | As the general quality of life, the SF-36 (the MOS 36-item short-form health survey) form will be used. | 8 weeks | 
| Plasma Fibrinogen and Haptoglobin Protein Levels | Two plasma proteins, fibrinogen and haptoglobin, will be evaluated as markers of inflammation. | 8 weeks |