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Multicomponent Therapy With Telerehabilitation

Primary Purpose

Fibromyalgia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
multicomponent therapy
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring telerehabilitation, multicomponent therapy, psychotherapy, pain, Fibromyalgia

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GROUP 1

GROUP 2

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 24, 2022
Last Updated
February 21, 2022
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT05250531
Brief Title
Multicomponent Therapy With Telerehabilitation
Official Title
Efficacy of Telerehabilitation and Multicomponent Therapy in Women With Fibromyalgia: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Patient education Exercise training Private Psychotherapy Relaxation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
telerehabilitation, multicomponent therapy, psychotherapy, pain, Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GROUP 1
Arm Type
Experimental
Arm 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.
Arm Title
GROUP 2
Arm Type
Active Comparator
Arm Description
As a control group, 33 patients selected to Group 2 (G2) will be given exercise and training with telerehabilitation.
Intervention Type
Behavioral
Intervention Name(s)
multicomponent therapy
Intervention Description
patient education,Exercise training,Private Psychotherapy,relaxation
Primary Outcome Measure Information:
Title
change in The Revised Fibromyalgia Impact Questionnaire (FIQR)
Description
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.
Time Frame
Baseline (before intervention), 1 month after intervention, 3 months after the intervention
Secondary Outcome Measure Information:
Title
change in Jenkins Sleep Evaluation Questionnaire (JSEQ)
Description
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.
Time Frame
Baseline (before intervention), 1 month after intervention, 3 months after the intervention
Title
change in The Fatigue Severity Scale (FSS)
Description
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.
Time Frame
Baseline (before intervention), 1 month after intervention, 3 months after the intervention
Title
change in Visual Analogue Scale (VAS)
Description
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.
Time Frame
Baseline (before intervention), 1 month after intervention, 3 months after the intervention
Title
change in ICF Core Set for Chronic Widespread Pain
Description
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.
Time Frame
Baseline (before intervention), 1 month after intervention, 3 months after the intervention
Title
change in The Central Sensitization (CSI) Inventory
Description
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.
Time Frame
Baseline (before intervention), 1 month after intervention, 3 months after the intervention
Title
change in hospital anxiety and depression scale
Description
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.
Time Frame
Baseline (before intervention), 1 month after intervention, 3 months after the intervention
Title
change in Short Form-36 (SF-36)
Description
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.
Time Frame
Baseline (before intervention), 1 month after intervention, 3 months after the intervention
Title
change in Pain Coping Inventory (PCI)
Description
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.
Time Frame
Baseline (before intervention), 1 month after intervention, 3 months after the intervention
Title
change in Pain Self Efficacy Questionnaire-2 (PSEQ-2)
Description
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.
Time Frame
Baseline (before intervention), after a month intervention, after 3 month the intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
effect of gender difference on intervention outcomes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women 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 Loss of sensation, loss of position sense, unhealed fracture or open surgical wound Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diren Ozer Ozbey, MD
Phone
+902124142000
Ext
31737
Email
direnozer@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diren Ozer Ozbey, MD
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diren Ozer Ozbey, MD
Phone
+902124142000
Ext
31737
Email
direnozer@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Multicomponent Therapy With Telerehabilitation

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