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

Not Applicable

• Conditions: Fibromyalgia
• Interventions: Other: Perceptive rehabilitation

• Registration Number: NCT03800199
• Lead Sponsor: European University of Lefke

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.

Study Timeline

• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-11
• Study Start: 2019-04-13
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-16
• Primary Completion: 2024-06
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Perceptive Rehabilitation (PR-group)	Perceptive rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Combined Index of Severity of Fibromyalgia	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.

Trial Locations

Locations (1)

Eastern Mediterranean University; 🇨🇾 Famagusta, Cyprus