Multicomponent Therapy With Telerehabilitation

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

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: multicomponent therapy

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

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diren Ozer Ozbey, MD; Phone Number: 31737 +902124142000; Email: direnozer@gmail.com

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34093
      • Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
      • Contact: Diren Ozer Ozbey, MD; Phone Number: 31737 +902124142000; Email: direnozer@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: multicomponent therapy; patient education,Exercise training,Private Psychotherapy,relaxation
Active Comparator: GROUP 2; As a control group, 33 patients selected to Group 2 (G2) will be given exercise and training with telerehabilitation.	Behavioral: multicomponent therapy; patient education,Exercise training,Private Psychotherapy,relaxation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Principal Investigator: Diren Ozer Ozbey, MD, Istanbul University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: pain; psychotherapy; Fibromyalgia; telerehabilitation; multicomponent therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: Istanbul University,Istanbul

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No