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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03800199
• Other study ID #: ETK00-2018-0281
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2019
• Est. completion date: July 2024

Study information

• Verified date: August 2022
• Source: European University of Lefke
• Contact: Beraat Alptug, MSc
• Phone: 05338498379
• Email: balptug[@]eul.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Cyprus	Eastern Mediterranean University	Famagusta

Sponsors (1)

Lead Sponsor	Collaborator
European University of Lefke

Country where clinical trial is conducted

Cyprus, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Revised-Fibromyalgia Impact Questionnaire (FIQR)	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.	Changes from baseline at 12 weeks.
Other	Socio-demographic and clinical characteristics	Date of birth, sex, marital status, profession, education status and time of the diagnosis of FMS will be noted.	Changes from baseline at 12 weeks.
Other	Body Mass Index (BMI)	Weight and height will be combined to report BMI in kg/m^2.	Changes from baseline at 12 weeks.
Other	Stanford Health Assessment Questionnaire (HAQ)	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.	Changes from baseline at 12 weeks.
Other	Fatigue Severity Scale (FSS)	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.	Changes from baseline at 12 weeks.
Other	Short-Form 36 (SF-36)	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.	Changes from baseline at 12 weeks.
Other	Pittsburgh Sleep Quality Index (PSQI)	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".	Changes from baseline at 12 weeks.
Primary	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.