Multicomponent Therapy With Telerehabilitation

Fibromyalgia Clinical Trial

Official title:

Efficacy of Telerehabilitation and Multicomponent Therapy in Women With Fibromyalgia: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05250531
• Other study ID #: Istanbul University,Istanbul
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2022
• Source: Istanbul University
• Contact: Diren Ozer Ozbey, MD
• Phone: +902124142000
• Email: direnozer[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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". Does it differ in terms of reduction and functionality?

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:

1. Patient education

2. Exercise training

3. Private Psychotherapy

4. Relaxation

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Women

2. Symptom persistence for more than 3 months

3. Pervasive Network Scale Score >7 and Symptom Severity Score >5 according to 2016 ACR criteria

4. Symptom Severity Score of >9 and Diffuse Pain Scale Score between 4-6 according to 2016 ACR criteria

5. Getting a high (11 and above) score on the Hospital Anxiety and Depression Scale

6. Having the opportunity to participate in the applications online

7. No change in the medical treatment he received for fibromyalgia syndrome during the study period

8. Those between the ages of 18-55

Exclusion Criteria:

1. Patients with endocrine, neuromuscular, infectious and inflammatory rheumatological diseases

2. Patients with liver or kidney disease

3. Patients with malignancy

4. Patients with a history of severe trauma

5. Patients with severe psychiatric illness

6. Patients with serious physical comorbidities

7. The illiterate

8. Known central nervous system or peripheral nervous system disease, progressive neurological deficit

9. Peripheral venous insufficiency, coagulopathies and anticoagulant drug use

10. Serious cardiovascular pathologies

11. Loss of sensation, loss of position sense, unhealed fracture or open surgical wound

12. Pregnancy

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• multicomponent therapy
patient education,Exercise training,Private Psychotherapy,relaxation

Locations

Country	Name	City	State
Turkey	Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (before intervention), 1 month after intervention, 3 months after the intervention
Secondary	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.	Baseline (before intervention), 1 month after intervention, 3 months after the intervention
Secondary	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.	Baseline (before intervention), 1 month after intervention, 3 months after the intervention
Secondary	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.	Baseline (before intervention), 1 month after intervention, 3 months after the intervention
Secondary	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.	Baseline (before intervention), 1 month after intervention, 3 months after the intervention
Secondary	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.	Baseline (before intervention), 1 month after intervention, 3 months after the intervention
Secondary	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.	Baseline (before intervention), 1 month after intervention, 3 months after the intervention
Secondary	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.	Baseline (before intervention), 1 month after intervention, 3 months after the intervention
Secondary	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.	Baseline (before intervention), 1 month after intervention, 3 months after the intervention
Secondary	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.	Baseline (before intervention), after a month intervention, after 3 month the intervention