Efficacy of Telerehabilitation and Multicomponent Therapy in Women With Fibromyalgia: A Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- Istanbul University
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- change in The Revised Fibromyalgia Impact Questionnaire (FIQR)
- Last Updated
- 4 years ago
Overview
Brief 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?
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: 1. Patient education 2. Exercise training 3. Private Psychotherapy 4. Relaxation
Investigators
DIREN OZER OZBEY
Principal Investigator
Istanbul University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- change in The Fatigue Severity Scale (FSS)(Baseline (before intervention), 1 month after intervention, 3 months after the intervention)
- change in Pain Coping Inventory (PCI)(Baseline (before intervention), 1 month after intervention, 3 months after the intervention)
- change in ICF Core Set for Chronic Widespread Pain(Baseline (before intervention), 1 month after intervention, 3 months after the intervention)
- change in Jenkins Sleep Evaluation Questionnaire (JSEQ)(Baseline (before intervention), 1 month after intervention, 3 months after the intervention)
- change in Visual Analogue Scale (VAS)(Baseline (before intervention), 1 month after intervention, 3 months after the intervention)
- change in The Central Sensitization (CSI) Inventory(Baseline (before intervention), 1 month after intervention, 3 months after the intervention)
- change in hospital anxiety and depression scale(Baseline (before intervention), 1 month after intervention, 3 months after the intervention)
- change in Short Form-36 (SF-36)(Baseline (before intervention), 1 month after intervention, 3 months after the intervention)
- change in Pain Self Efficacy Questionnaire-2 (PSEQ-2)(Baseline (before intervention), after a month intervention, after 3 month the intervention)