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

NCT03800199 | Unknown

• 1 other identifier: ETK00-2018-0281
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Fibromyalgia

Keywords

health statues; observational study; questionnaire

Outcome Measures

Primary Outcomes (1)

• 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.

Other Outcomes (7)

• Revised-Fibromyalgia Impact Questionnaire (FIQR)

  Changes from baseline at 12 weeks.

• Socio-demographic and clinical characteristics

  Changes from baseline at 12 weeks.

• Body Mass Index (BMI)

  Changes from baseline at 12 weeks.

Study Arms (1)

Perceptive Rehabilitation (PR-group)

EXPERIMENTAL

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

Interventions

Perceptive rehabilitation 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.

Perceptive Rehabilitation (PR-group)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Having a Fibromyalgia diagnosis according to Wolfe et al. (2016) criteria.
• Feeling Fibromyalgia symptoms last 3 mounts

You may not qualify if:

• 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

Sponsors & Collaborators

• European University of Lefke: lead

Study Sites (1)

Eastern Mediterranean University

Famagusta, Cyprus

RECRUITING

Related Publications (1)

• 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.

  PMID: 26884794 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Beraat Alptug, MSc

  European University of Lefke

  PRINCIPAL INVESTIGATOR

• Emine H. Tüzün, Prof. Dr.

  Eastern Mediterranean University

  PRINCIPAL INVESTIGATOR

• Levent Eker, M. D.

  Eastern Mediterranean University

  PRINCIPAL INVESTIGATOR

• Gülbin Ergin, PhD

  European University of Lefke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beraat Alptug, MSc

CONTACT

05338498379; balptug@eul.edu.tr

Emine H. Tüzün, Prof. Dr.

CONTACT

+903926301370; handan.tuzun@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Physiotherapist/ Principal Investigator

Model Details: Questionnaire: Combined Index of Severity of Fibromyalgia (ICAF) Intervention: Perceptive rehabilitation Procedure: Assessment of reliability, acceptability, validity and responsiveness.

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 11, 2019
• Study Start: April 13, 2019
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 16, 2022

Record last verified: 2022-08

Locations

CY (1)