Clinical trial NCT03800199: The Validity and Reliability of the Turkish Version of the Combined Index of Severity of Fibromyalgia
Official title: The Validity and Reliability of the Turkish Version of the Combined Index of Severity of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: health statues
observational study
questionnaire
Lead sponsor: European University of Lefke
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Questionnaire: Combined Index of Severity of Fibromyalgia (ICAF)

Intervention: Perceptive rehabilitation

Procedure: Assessment of reliability, acceptability, validity and responsiveness.
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Combined Index of Severity of Fibromyalgia
timeFrame: Changes from baseline severity at 12 weeks.
Secondary outcomes:
Other outcomes:
measure: Revised-Fibromyalgia Impact Questionnaire (FIQR)
timeFrame: Changes from baseline at 12 weeks.
measure: Socio-demographic and clinical characteristics
timeFrame: Changes from baseline at 12 weeks.
measure: Body Mass Index (BMI)
timeFrame: Changes from baseline at 12 weeks.
measure: Stanford Health Assessment Questionnaire (HAQ)
timeFrame: Changes from baseline at 12 weeks.
measure: Fatigue Severity Scale (FSS)
timeFrame: Changes from baseline at 12 weeks.
measure: Short-Form 36 (SF-36)
timeFrame: Changes from baseline at 12 weeks.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Changes from baseline at 12 weeks.
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterranean University
Study officials:
affiliation: European University of Lefke
name: Beraat Alptug, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Mediterranean University
name: Emine H. Tüzün, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Mediterranean University
name: Levent Eker, M. D.
role: PRINCIPAL_INVESTIGATOR
affiliation: European University of Lefke
name: Gülbin Ergin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paolucci T, Baldari C, Di Franco M, Didona D, Reis V, Vetrano M, Iosa M, Trifoglio D, Zangrando F, Spadini E, Saraceni VM, Guidetti L. A New Rehabilitation Tool in Fibromyalgia: The Effects of Perceptive Rehabilitation on Pain and Function in a Clinical Randomized Controlled Trial. Evid Based Complement Alternat Med. 2016;2016:7574589. doi: 10.1155/2016/7574589. Epub 2016 Jan 13.