FibromyalgiaNCT05250531
Multicomponent Therapy With Telerehabilitation
A study testing multicomponent therapy in people with Fibromyalgia, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In this prospective, randomized study, our aim was to evaluate the comprehensive multicomponent treatment of fibromyalgia women with telerehabilitation, including "patient education, special psychotherapy/psychosocial intervention, and exercise including relaxation exercises". Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- multicomponent therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 1 Dec 2022
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women
- Symptom persistence for more than 3 months
- Pervasive Network Scale Score >7 and Symptom Severity Score >5 according to 2016 ACR criteria
- Symptom Severity Score of >9 and Diffuse Pain Scale Score between 4-6 according to 2016 ACR criteria
- Getting a high (11 and above) score on the Hospital Anxiety and Depression Scale
- Having the opportunity to participate in the applications online
- No change in the medical treatment he received for fibromyalgia syndrome during the study period
- Those between the ages of 18-55
Who cannot join
- Patients with endocrine, neuromuscular, infectious and inflammatory rheumatological diseases
- Patients with liver or kidney disease
- Patients with malignancy
- Patients with a history of severe trauma
- Patients with severe psychiatric illness
- Patients with serious physical comorbidities
Show all 12Show fewer
- The illiterate
- Known central nervous system or peripheral nervous system disease, progressive neurological deficit
- Peripheral venous insufficiency, coagulopathies and anticoagulant drug use
- Serious cardiovascular pathologies
- Loss of sensation, loss of position sense, unhealed fracture or open surgical wound
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, Fatih, 34093
Diren Ozer Ozbey, MD, +902124142000 ext. 31737, direnozer@gmail.com
About this study
Official title: Efficacy of Telerehabilitation and Multicomponent Therapy in Women With Fibromyalgia: A Randomized Controlled Trial
In this prospective, randomized study, our aim was to evaluate the comprehensive multicomponent treatment of fibromyalgia women with telerehabilitation, including "patient education, special psychotherapy/psychosocial intervention, and exercise including relaxation exercises". Does it differ in terms of reduction and functionality?
Read the detailed description
Patients who meet the inclusion criteria will be randomized into two groups by computer program after being numbered according to the order of application. 33 patients in the multicomponent treatment group selected to group 1 (G1) will be treated with telerehabilitation for a total of 6 sessions of two hours once a week for 3 weeks. After 1 month, one more session will be applied for a two-hour follow-up and sustainability. As a control group, 33 patients selected to Group 2 (G2) will be given exercise and training with telerehabilitation.
Patients to whom a multicomponent treatment program will be applied will be included in the program in groups of 10. The presentations will be prepared as power-point presentations and will be presented to the patients online with telerehabilitation.
Interventions to be applied in the multicomponent treatment protocol:
- Patient education
- Exercise training
- Private Psychotherapy
- Relaxation
- Conditions
- Fibromyalgia
- Being tested
- multicomponent therapy
- Keywords
- telerehabilitation, multicomponent therapy, psychotherapy, pain, Fibromyalgia
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multicomponent therapyBehavioural
patient education,Exercise training,Private Psychotherapy,relaxation
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 | Experimental | 33 patients in the multicomponent treatment group selected to group 1 (G1) will be treated with telerehabilitation for a total of 6 sessions of two hours once a week for 3 weeks. After 1 month, one more session will be applied for a two-hour follow-up and sustainability. Receives: Behavioral: multicomponent therapy |
| GROUP 2 | Active comparator | As a control group, 33 patients selected to Group 2 (G2) will be given exercise and training with telerehabilitation. Receives: Behavioral: multicomponent therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in The Revised Fibromyalgia Impact Questionnaire (FIQR)
The fibromyalgia impact questionnaire was developed from information gathered from patient reports, functional status tools, and clinical observations. This questionnaire measures physical function, work status (days off and work difficulty), depression, anxiety, morning fatigue, pain, stiffness, fatigue, and well-being in the past week.
Measured: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
Secondary outcomes (9)
change in Jenkins Sleep Evaluation Questionnaire (JSEQ)
It is important to evaluate and treat sleep problems. It consists of four items that evaluate sleep problems in the last four weeks. It is a simple, time-consuming and easily calculated sleep assessment tool that can be used in fibromyalgia patients.
Measured: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
change in The Fatigue Severity Scale (FSS)
It consists of nine items that measure the severity of the patients' fatigue symptoms in the last week. It assesses the prevalence and severity of fatigue, the management of affected patients, and the monitoring of disease-related fatigue.
Measured: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
change in Visual Analogue Scale (VAS)
Pain will be evaluated with the Visual Analogue Scale (VAS). The numerical value obtained by measuring in millimeters will show the patient's pain intensity (0 = no pain, 10 = most severe pain). The patient will be asked about the average of the pain intensity felt in the last week.
Measured: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
change in ICF Core Set for Chronic Widespread Pain
It was aimed to determine the functional characteristics of the patients, the impairments in body functions, activity limitations and participation limitations, and the facilitating or inhibiting effects of environmental factors.
Measured: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
change in The Central Sensitization (CSI) Inventory
It is a scale used to detect patients with symptoms related to central sensitization or types of central sensitization syndrome such as fibromyalgia, temporomandibular joint disease, tension-type headache, migraine.
Measured: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
change in hospital anxiety and depression scale
It is a self-report scale consisting of 14 items. Single items provide an assessment of anxiety and dual items of depression. It is used in the evaluation of patients with physical health since it does not contain physical symptoms.
Measured: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
change in Short Form-36 (SF-36)
Quality of life will be measured with Short Form-36 (Short Form-36, SF-36). SF-36 is one of the most widely used criteria among generic criteria. It is a valid and frequently used criterion for assessing quality of life. It is not specific to any age, disease or treatment group. It includes general health concepts. It was developed for use in clinical practice and research. It includes 36 questions on eight subscales: physical function, physical role difficulty, body pain, general health, vitality, social function, emotional role difficulty, and mental health.
Measured: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
change in Pain Coping Inventory (PCI)
It was developed by Kraaimaat and Evers (2003) in order to determine the behavioral and cognitive strategies used by chronic pain patients to cope with pain. It consists of six sub-dimensions and 22 items. The lowest score that can be obtained from all sub-dimensions of the questionnaire, which is evaluated with a 4-point Likert type, is one and the highest score is four. Sub-dimensions are scored by dividing by the number of items.
Measured: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
change in Pain Self Efficacy Questionnaire-2 (PSEQ-2)
It is stated that self-efficacy for coping with pain can also be measured with a two-item short form. The high score obtained from the questionnaire evaluated with a five-point Likert-type scale indicates that the individuals' self-efficacy regarding pain has increased. A minimum of one and a maximum of five points are taken from the scale.
Measured: Baseline (before intervention), after a month intervention, after 3 month the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DIREN OZER OZBEY, Istanbul University
- Investigators
- Diren Ozer Ozbey, MD, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250531
- Sponsor's protocol ID
- Istanbul University,Istanbul
- Status last verified
- Feb 2022
- First submitted
- 24 Jan 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Telerehabilitation and Multicomponent Therapy in Women With Fibromyalgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05250531
- Acronym / sponsor ID
- Istanbul University,Istanbul
- Conditions
- Fibromyalgia
- Keywords
- telerehabilitation, multicomponent therapy, psychotherapy, pain, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 22 Feb 2022 (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.
In this prospective, randomized study, our aim was to evaluate the comprehensive multicomponent treatment of fibromyalgia women with telerehabilitation, including "patient education, special psychotherapy/psychosocial intervention, and exercise including relaxation exercises". Does it differ in terms of reduction and functionality?
Detailed description
Patients who meet the inclusion criteria will be randomized into two groups by computer program after being numbered according to the order of application. 33 patients in the multicomponent treatment group selected to group 1 (G1) will be treated with telerehabilitation for a total of 6 sessions of two hours once a week for 3 weeks. After 1 month, one more session will be applied for a two-hour follow-up and sustainability. As a control group, 33 patients selected to Group 2 (G2) will be given exercise and training with telerehabilitation.
Patients to whom a multicomponent treatment program will be applied will be included in the program in groups of 10. The presentations will be prepared as power-point presentations and will be presented to the patients online with telerehabilitation.
Interventions to be applied in the multicomponent treatment protocol:
- Patient education
- Exercise training
- Private Psychotherapy
- Relaxation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 | Experimental | Behavioral: multicomponent therapy33 patients in the multicomponent treatment group selected to group 1 (G1) will be treated with telerehabilitation for a total of 6 sessions of two hours once a week for 3 weeks. After 1 month, one more session will be applied for a two-hour follow-up and sustainability. |
| GROUP 2 | Active comparator | Behavioral: multicomponent therapyAs a control group, 33 patients selected to Group 2 (G2) will be given exercise and training with telerehabilitation. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women
- Symptom persistence for more than 3 months
- Pervasive Network Scale Score >7 and Symptom Severity Score >5 according to 2016 ACR criteria
- Symptom Severity Score of >9 and Diffuse Pain Scale Score between 4-6 according to 2016 ACR criteria
- Getting a high (11 and above) score on the Hospital Anxiety and Depression Scale
Key exclusion criteria (12 listed)
- Patients with endocrine, neuromuscular, infectious and inflammatory rheumatological diseases
- Patients with liver or kidney disease
- Patients with malignancy
- Patients with a history of severe trauma
- Patients with severe psychiatric illness
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 |
|---|---|---|
| multicomponent therapypatient education,Exercise training,Private Psychotherapy,relaxation | Behavioural | GROUP 1, GROUP 2 |
Primary outcome
change in The Revised Fibromyalgia Impact Questionnaire (FIQR)
Time frame: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
The fibromyalgia impact questionnaire was developed from information gathered from patient reports, functional status tools, and clinical observations. This questionnaire measures physical function, work status (days off and work difficulty), depression, anxiety, morning fatigue, pain, stiffness, fatigue, and well-being in the past week.
9 secondary outcomes
change in Jenkins Sleep Evaluation Questionnaire (JSEQ)
Time frame: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
change in The Fatigue Severity Scale (FSS)
Time frame: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
change in Visual Analogue Scale (VAS)
Time frame: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
change in ICF Core Set for Chronic Widespread Pain
Time frame: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
change in The Central Sensitization (CSI) Inventory
Time frame: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
change in hospital anxiety and depression scale
Time frame: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
change in Short Form-36 (SF-36)
Time frame: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
change in Pain Coping Inventory (PCI)
Time frame: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
change in Pain Self Efficacy Questionnaire-2 (PSEQ-2)
Time frame: Baseline (before intervention), after a month intervention, after 3 month the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Diren Ozer Ozbey, MD principal investigator
Istanbul 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 multicomponent therapy in people with Fibromyalgia, run by Istanbul University at 1 site in Turkey (Türkiye).
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 8 inclusion and 12 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 22 Feb 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 Turkey (Türkiye). 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 Diren Ozer Ozbey, MD (+902124142000 ext. 31737, direnozer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in The Revised Fibromyalgia Impact Questionnaire (FIQR) (time frame: Baseline (before intervention), 1 month after intervention, 3 months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2022.