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

Primary Purpose

Fibromyalgia

Status
Recruiting
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Perceptive rehabilitation
Sponsored by
European University of Lefke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fibromyalgia focused on measuring health statues, observational study, questionnaire

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eastern Mediterranean UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Perceptive Rehabilitation (PR-group)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 7, 2019
Last Updated
August 15, 2022
Sponsor
European University of Lefke
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1. Study Identification

Unique Protocol Identification Number
NCT03800199
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
European University of Lefke

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
health statues, observational study, questionnaire

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Questionnaire: Combined Index of Severity of Fibromyalgia (ICAF) Intervention: Perceptive rehabilitation Procedure: Assessment of reliability, acceptability, validity and responsiveness.
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Perceptive Rehabilitation (PR-group)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Perceptive rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Combined Index of Severity of Fibromyalgia
Description
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.
Time Frame
Changes from baseline severity at 12 weeks.
Other Pre-specified Outcome Measures:
Title
Revised-Fibromyalgia Impact Questionnaire (FIQR)
Description
The Turkish version of FIQR will be used in this study. This questionnaire has 21 individual questions. All these questions should be answered according to the past 7 days. FIQR has divided into three sections; 'function, overall impact and symptoms'. The total FIQR score will be calculated with the sum of the three domain scores. The total score will be out of 100. The higher score means a severe impact.
Time Frame
Changes from baseline at 12 weeks.
Title
Socio-demographic and clinical characteristics
Description
Date of birth, sex, marital status, profession, education status and time of the diagnosis of FMS will be noted.
Time Frame
Changes from baseline at 12 weeks.
Title
Body Mass Index (BMI)
Description
Weight and height will be combined to report BMI in kg/m^2.
Time Frame
Changes from baseline at 12 weeks.
Title
Stanford Health Assessment Questionnaire (HAQ)
Description
This questionnaire will be use to asses general health of the participants.There are 20 questions in 8 sub categories of functioning (dressing, rising, eating, walking, hygiene, reach, grip, and usual activities), 1 question is about pain and 1 question is about general health. Disability index questions has four possible answers (without any difficulty: 0, with some difficulty: 1, with much difficulty: 2, unable to do: 3). Highest score represent the worsening.
Time Frame
Changes from baseline at 12 weeks.
Title
Fatigue Severity Scale (FSS)
Description
Turkish version of Fatigue Severity Scale (FSS) will be used in this study. This scale has 9 items. Each item should be scored (strongly disagrees) 0 to 7 (strongly agrees). The minimum score=9 and maximum score possible=63. Higher score=greater fatigue severity. The average score for all 9 items constitutes the FSS score.
Time Frame
Changes from baseline at 12 weeks.
Title
Short-Form 36 (SF-36)
Description
The quality of life questionnaire Short Form 36 (SF-36) is multidimensional, consisting of 36 items, divided into eight scales, each scale assesses a health concept, they are: limitations in physical activities because of health problems, limitations in social activities due to physical or emotional problems, limitations in daily activities due to health problems, body pain, mental health, limitations in daily activities due to emotional problems, vitality, perception of general health. All categories have their own score out of 100. Higher scores mean a better quality of life.
Time Frame
Changes from baseline at 12 weeks.
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Turkish version of Pittsburgh Sleep Quality Index (PSQI) will be used in this study. This is a self-reported index that has 19 items with Likert and open-ended response formats. This index should be answered according to the past month. Minimum Score "0" means "good sleep" and Maximum Score "30" means "disrupted sleep".
Time Frame
Changes from baseline at 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beraat Alptug, MSc
Phone
05338498379
Email
balptug@eul.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Emine H. Tüzün, Prof. Dr.
Phone
+903926301370
Ext
1370
Email
handan.tuzun@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beraat Alptug, MSc
Organizational Affiliation
European University of Lefke
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emine H. Tüzün, Prof. Dr.
Organizational Affiliation
Eastern Mediterranean University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Levent Eker, M. D.
Organizational Affiliation
Eastern Mediterranean University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gülbin Ergin, PhD
Organizational Affiliation
European University of Lefke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Mediterranean University
City
Famagusta
Country
Cyprus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emine H Tuzun, Prof
Phone
+903926301370
Ext
1370

12. IPD Sharing Statement

Citations:
PubMed Identifier
26884794
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.
Results Reference
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The Validity and Reliability of the Turkish Version of the Combined Index of Severity of Fibromyalgia

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