The Validity and Reliability of the Turkish Version of the Combined Index of Severity of Fibromyalgia

Study Overview
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Brief Summary
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The aim of the investigator's study is to determine the validity and reliability of the Turkish version of the Combined Index of Severity (ICAF) in Turkish patients with Fibromyalgia Syndrome (FMS).

Detailed Description
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The original form of the Combined Index of Severity of Fibromyalgia (ICAF) will be translated into Turkish by two Turkish mother tongue translators who also speak English in advanced level. Then these translations will be combined into one translation and translated back to English. These translations will send to 7 different health professions who had experience working with FMS patients. The pre-final version will be composed and tested on a group of patients with FMS. If necessary, readjustments will be made, and the final version will be investigated in FMS patients. Acceptability was assessed in terms of refusal rate, rates of missing responses, and administration time. Reliability was assessed using Cronbach's alpha and test-retest assessments. Re-test assessments will be conducted after one week from first assessment. Content validity was assessed by examining the floor and ceiling effects and skew of the distributions. Convergent and divergent validity was assessed by examining the Pearson's correlation coefficients. In addition, the confirmatory factor analysis will be done to evaluate the validity of ICAF. Responsiveness was determined by examining effect size (ES), standardized response means (SRM) and P values generated using Wilcoxon's test.

Official Title
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The Validity and Reliability of the Turkish Version of the Combined Index of Severity of Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Perceptive rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having a Fibromyalgia diagnosis according to Wolfe et al. (2016) criteria. Feeling Fibromyalgia symptoms last 3 mounts Exclusion Criteria: Having physical and functional problems with FMS Having a diagnosis of chronic pain other than FMS, Using medicine other than simple analgesics, History of cardiovascular or pulmonary diseases Can not read and write in Turkish language

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Questionnaire: Combined Index of Severity of Fibromyalgia (ICAF) Intervention: Perceptive rehabilitation Procedure: Assessment of reliability, acceptability, validity and responsiveness.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perceptive Rehabilitation (PR-group)<br>Perceptive rehabilitation group will receive a treatment that, as described by on Paolucci et al. (2015). This treatment will include small latex cones with different resistance. In each session there will be over 100 cones will be placed on a rigid wood with using elastic strips. The patient will be asked to lie down supine on the material. Patients weigh will create pressure and reaction force to his/her body. Treatments will be 2 times a week till 8 weeks. There will be in total 16 sessions. | Other: Perceptive rehabilitation<br>* The first session will be an education session. Spinous processes will be reference line of the body and patient will lie down on cones. The therapist will ask the patient first to breathe normally and feel the pressure. This will lead the patient to relax and understand cones. Then, the patient will start with the diagrammatic breathing. After breath exercises patient will perform active exercises (include stretching, warming up and cooling down) on supervision. Exercises will include the whole body. Additional to this during the session therapist will ask about the pressure of cones and she will correct the patients' posture. At the end of all the session, the therapist will take a photo of the patients back with the aim of to document the pressure and hyperaemic areas.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined Index of Severity of Fibromyalgia | Composed of 59 items, measures the combined severity index of fibromyalgia divided into 4 factors: physical, emotional, social and active and passive coping.The ICAF score ranges from 0 to 84, with higher values indicating higher severity. | Changes from baseline severity at 12 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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health statues, observational study, questionnaire