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Clinical Trials/NCT03800199
NCT03800199
Unknown
Not Applicable

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

European University of Lefke1 site in 1 country200 target enrollmentApril 13, 2019
ConditionsFibromyalgia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
European University of Lefke
Enrollment
200
Locations
1
Primary Endpoint
Combined Index of Severity of Fibromyalgia
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 13, 2019
End Date
July 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
European University of Lefke
Responsible Party
Principal Investigator
Principal Investigator

Beraat Alptug

Master Physiotherapist/ Principal Investigator

European University of Lefke

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

Outcomes

Primary Outcomes

Combined Index of Severity of Fibromyalgia

Time Frame: Changes from baseline severity at 12 weeks.

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.

Study Sites (1)

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