Multicomponent Therapy With Telerehabilitation

NCT ID: NCT05250531

Last Updated: 2022-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-12-01

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

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

GROUP 1

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.

Group Type: EXPERIMENTAL

multicomponent therapy

Intervention Type: BEHAVIORAL

patient education,Exercise training,Private Psychotherapy,relaxation

GROUP 2

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

Group Type: ACTIVE_COMPARATOR

multicomponent therapy

Intervention Type: BEHAVIORAL

patient education,Exercise training,Private Psychotherapy,relaxation

Interventions

multicomponent therapy

patient education,Exercise training,Private Psychotherapy,relaxation

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

DIREN OZER OZBEY

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diren Ozer Ozbey, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul University

Locations

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, Fatih, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Diren Ozer Ozbey, MD

Role: CONTACT

direnozer@gmail.com

+902124142000 ext. 31737

Facility Contacts

Diren Ozer Ozbey, MD

Role: primary

direnozer@gmail.com

+902124142000 ext. 31737

Other Identifiers

Istanbul University,Istanbul

Identifier Type: -

Identifier Source: org_study_id