Multicomponent Therapy With Telerehabilitation

Istanbul University

Status: Unknown

Conditions: Fibromyalgia

Treatments: Behavioral: multicomponent therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05250531

Istanbul University,Istanbul

Details and patient eligibility

About

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?

Full 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

Enrollment: 66 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

GROUP 1

Experimental group

Description:

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.

Treatment:

Behavioral: multicomponent therapy

GROUP 2

Active Comparator group

Description:

As a control group, 33 patients selected to Group 2 (G2) will be given exercise and training with telerehabilitation.

Treatment:

Behavioral: multicomponent therapy