FibromyalgiaNCT03800199
The Validity and Reliability of the Turkish Version of the Combined Index of Severity of Fibromyalgia
A study testing Perceptive rehabilitation in people with Fibromyalgia, run by European University of Lefke at 1 site in Cyprus.
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Perceptive rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCyprus
- Study dates
- 13 Apr 2019to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having a Fibromyalgia diagnosis according to Wolfe et al. (2016) criteria.
- Feeling Fibromyalgia symptoms last 3 mounts
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Cyprus1 site, 1 recruiting
- Recruiting
Eastern Mediterranean University
Famagusta
Emine H Tuzun, Prof, +903926301370 ext. 1370
About this study
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).
Read the 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
- Being tested
- Perceptive rehabilitation
- Keywords
- health statues, observational study, questionnaire
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perceptive rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Perceptive rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Changes from baseline severity at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start13 Apr 2019
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European University of Lefke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beraat Alptug, European University of Lefke
- Investigators
- Beraat Alptug, MSc, Principal investigator, European University of LefkeEmine H. Tüzün, Prof. Dr., Principal investigator, Eastern Mediterranean UniversityLevent Eker, M. D., Principal investigator, Eastern Mediterranean UniversityGülbin Ergin, PhD, Principal investigator, European University of Lefke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800199
- Sponsor's protocol ID
- ETK00-2018-0281
- Status last verified
- Aug 2022
- First submitted
- 7 Jan 2019
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26884794
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity and Reliability of the Turkish Version of the Combined Index of Severity of Fibromyalgia
- ClinicalTrials.gov ID
- NCT03800199
- Acronym / sponsor ID
- ETK00-2018-0281
- Conditions
- Fibromyalgia
- Keywords
- health statues, observational study, questionnaire
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- European University of LefkeUniversity, hospital or other
- Study start
- 13 Apr 2019 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Questionnaire: Combined Index of Severity of Fibromyalgia (ICAF) Intervention: Perceptive rehabilitation Procedure: Assessment of reliability, acceptability, validity and responsiveness.
| Arm | Type | Receives |
|---|---|---|
| Perceptive Rehabilitation (PR-group) | Experimental | Other: Perceptive rehabilitationPerceptive 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Having a Fibromyalgia diagnosis according to Wolfe et al. (2016) criteria.
- Feeling Fibromyalgia symptoms last 3 mounts
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perceptive rehabilitationThe 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. | Other | Perceptive Rehabilitation (PR-group) |
Primary outcome
Combined Index of Severity of Fibromyalgia
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Background: PubMed 26884794Paolucci 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beraat Alptug, MSc principal investigator
European University of Lefke
Emine H. Tüzün, Prof. Dr. principal investigator
Eastern Mediterranean University
Levent Eker, M. D. principal investigator
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perceptive rehabilitation in people with Fibromyalgia, run by European University of Lefke at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beraat Alptug, MSc (05338498379, balptug@eul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined Index of Severity of Fibromyalgia (time frame: Changes from baseline severity at 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03800199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.