Clinical trial NCT05250531: Multicomponent Therapy With Telerehabilitation
Official title: Efficacy of Telerehabilitation and Multicomponent Therapy in Women With Fibromyalgia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: telerehabilitation
multicomponent therapy
psychotherapy
pain
Fibromyalgia
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: change in The Revised Fibromyalgia Impact Questionnaire (FIQR)
timeFrame: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
Secondary outcomes:
measure: change in Jenkins Sleep Evaluation Questionnaire (JSEQ)
timeFrame: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
measure: change in The Fatigue Severity Scale (FSS)
timeFrame: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
measure: change in Visual Analogue Scale (VAS)
timeFrame: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
measure: change in ICF Core Set for Chronic Widespread Pain
timeFrame: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
measure: change in The Central Sensitization (CSI) Inventory
timeFrame: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
measure: change in hospital anxiety and depression scale
timeFrame: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
measure: change in Short Form-36 (SF-36)
timeFrame: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
measure: change in Pain Coping Inventory (PCI)
timeFrame: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
measure: change in Pain Self Efficacy Questionnaire-2 (PSEQ-2)
timeFrame: Baseline (before intervention), after a month intervention, after 3 month the intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
state: Fatih
Study officials:
affiliation: Istanbul University
name: Diren Ozer Ozbey, MD
role: PRINCIPAL_INVESTIGATOR
References: