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

NCT ID: NCT03800199

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-13
• Study Completion Date: 2024-07-31

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Perceptive Rehabilitation (PR-group)

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.

Group Type: EXPERIMENTAL

Perceptive rehabilitation

Intervention Type: OTHER

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.

Interventions

Perceptive rehabilitation

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European University of Lefke

OTHER

Sponsor Role: lead

Responsible Party

Beraat Alptug

Master Physiotherapist/ Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Beraat Alptug, MSc

Role: PRINCIPAL_INVESTIGATOR

European University of Lefke

Emine H. Tüzün, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Eastern Mediterranean University

Levent Eker, M. D.

Role: PRINCIPAL_INVESTIGATOR

Eastern Mediterranean University

Gülbin Ergin, PhD

Role: PRINCIPAL_INVESTIGATOR

European University of Lefke

Locations

Eastern Mediterranean University

Famagusta, , Cyprus

Site Status: RECRUITING

Countries

Cyprus

Central Contacts

Beraat Alptug, MSc

Role: CONTACT

balptug@eul.edu.tr

05338498379

Emine H. Tüzün, Prof. Dr.

Role: CONTACT

handan.tuzun@gmail.com

+903926301370 ext. 1370

Facility Contacts

Emine H Tuzun, Prof

Role: primary

+903926301370 ext. 1370

References

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.

Reference Type: BACKGROUND

PMID: 26884794 (View on PubMed)

Other Identifiers

ETK00-2018-0281

Identifier Type: -

Identifier Source: org_study_id