Back to resultsComparison of the Effects of Face-to-Face and Internet-Based BBAT in Fibromyalgia Syndrome
Primary Purpose
Fibromyalgia
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
BBAT (Basic Body Awareness Therapy)
Online BBAT training
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility Criteria
Inclusion Criteria:
- To be between the ages of 18-65
- Being diagnosed with FMS according to ACR 2010 criteria
- To be diagnosed with FMS at least 6 months before the study
- Reported pain intensity > 4 (Visual Analog Scale 0-10),
- Individuals that do not have barriers to basic body awareness therapy.
Exclusion Criteria:
- Pregnancy or intention to become pregnant within the study period.
- Substance and alcohol abuse, major psychiatric disorder (preventing compliance), uncontrolled hypertension, diabetes, congestive heart failure, or other serious chronic medical condition that puts the patient at risk for the clinician to expose the patient to potentially serious consequences of their illness
- Those who have malignancy and those receiving chemotherapy and radiotherapy causing malignancy
- Those who have suffered from any musculoskeletal, neurological, rheumatological disorder or any condition that may interfere with evaluations (advanced respiratory or orthopedic problems such as fractures, sprains or strains, or spinal surgery) in the past 12 months -
Sites / Locations
- Beykent University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
The group I: BBAT Face-to-Face Training group
The group II: Online BBAT training group
The group III: Control group
Arm Description
Exercises consist of supine, sitting, standing position awareness exercises and walking exercises. Considering eight weeks, the training is designed to progress gradually each week.
Patients in the Internet-based BFT group will conduct their training with a physiotherapist to be connected via an online video conference system. This group will be given the same training as the face-to-face BFT group.
No training will be applied to the control group patients.
Outcomes
Primary Outcome Measures
The Revised Fibromyalgia Impact Questionnaire (FIQR)
Limitations and functional disability in patients with fibromyalgia will be evaluated.
Algometer
Pressure pain threshold measurement of characteristic 18 tender points of fibromyalgia syndrome will be performed.
Awareness-Body-Chart=ABC
Awareness-Body-Chart=ABC will be used to assess body awareness.
Posture Screen Mobile (PSM)
Posture will be evaluated with Posture Screen Mobile (PSM), an iPad application.
Secondary Outcome Measures
The short-form McGill Pain Questionnaire
Pain will be evaluated with the short-form McGill Pain Questionnaire
Trunk repositioning error
The trunk position sense indicated by trunk reposition errors will be evaluated with the inclinometer device.
Postural stability
Postural stability will be evaluated with a portable force platform.
Single Leg Balance
Balance will be evaluated with the single leg balance test with eyes open and closed.
Pittsburgh Sleep Quality Index
Sleep quality will be assessed by the Pittsburgh Sleep Quality Index.
SF-36 (the MOS 36-item short-form health survey)
As the general quality of life, the SF-36 (the MOS 36-item short-form health survey) form will be used.
Plasma Fibrinogen and Haptoglobin Protein Levels
Two plasma proteins, fibrinogen and haptoglobin, will be evaluated as markers of inflammation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04970511
Brief Title
Comparison of the Effects of Face-to-Face and Internet-Based BBAT in Fibromyalgia Syndrome
Official Title
Comparison of the Effects of Face-to-Face and Internet-Based Basic Body Awareness Therapy in Fibromyalgia Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
July 20, 2023 (Anticipated)
Study Completion Date
July 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Beykent
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
The aim of our study is to compare the effects of face-to-face and internet-based BBAT in patients diagnosed with Fibromyalgia Syndrome.
H0: Face-to-face and internet-based CFT have superiority over each other in patients diagnosed with Fibromyalgia Syndrome.
H1: In patients diagnosed with Fibromyalgia Syndrome, face-to-face and internet-based CFT have no superiority over each other.
Detailed Description
The aim of our study is to compare the effects of face-to-face and internet-based BBAT in patients diagnosed with Fibromyalgia Syndrome.
H0: Face-to-face and internet-based CFT have superiority over each other in patients diagnosed with Fibromyalgia Syndrome.
H1: In patients diagnosed with Fibromyalgia Syndrome, face-to-face and internet-based CFT have no superiority over each other.
Goals:
Investigation of the effects of face-to-face and internet-based BBAT on functional disability, pressure pain threshold, body awareness, posture, pain intensity, trunk position sense, postural control, balance, sleep quality, quality of life and inflammation level in patients diagnosed with Fibromyalgia Syndrome.
Comparison of the effects of face-to-face and internet-based BBAT on functional disability, pressure pain threshold, body awareness, posture, pain intensity, trunk position sense, postural control, balance, sleep quality, quality of life and inflammation level in patients diagnosed with Fibromyalgia Syndrome
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The group I: BBAT Face-to-Face Training group
Arm Type
Experimental
Arm Description
Exercises consist of supine, sitting, standing position awareness exercises and walking exercises.
Considering eight weeks, the training is designed to progress gradually each week.
Arm Title
The group II: Online BBAT training group
Arm Type
Experimental
Arm Description
Patients in the Internet-based BFT group will conduct their training with a physiotherapist to be connected via an online video conference system.
This group will be given the same training as the face-to-face BFT group.
Arm Title
The group III: Control group
Arm Type
No Intervention
Arm Description
No training will be applied to the control group patients.
Intervention Type
Behavioral
Intervention Name(s)
BBAT (Basic Body Awareness Therapy)
Intervention Description
The group I: BBAT Face-to-Face Training (60 min) will be provided.
Intervention Type
Behavioral
Intervention Name(s)
Online BBAT training
Intervention Description
The group II: Online BBAT training (60 min) will be provided.
Primary Outcome Measure Information:
Title
The Revised Fibromyalgia Impact Questionnaire (FIQR)
Description
Limitations and functional disability in patients with fibromyalgia will be evaluated.
Time Frame
8 weeks
Title
Algometer
Description
Pressure pain threshold measurement of characteristic 18 tender points of fibromyalgia syndrome will be performed.
Time Frame
8 weeks
Title
Awareness-Body-Chart=ABC
Description
Awareness-Body-Chart=ABC will be used to assess body awareness.
Time Frame
8 weeks
Title
Posture Screen Mobile (PSM)
Description
Posture will be evaluated with Posture Screen Mobile (PSM), an iPad application.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
The short-form McGill Pain Questionnaire
Description
Pain will be evaluated with the short-form McGill Pain Questionnaire
Time Frame
8 weeks
Title
Trunk repositioning error
Description
The trunk position sense indicated by trunk reposition errors will be evaluated with the inclinometer device.
Time Frame
8 weeks
Title
Postural stability
Description
Postural stability will be evaluated with a portable force platform.
Time Frame
8 weeks
Title
Single Leg Balance
Description
Balance will be evaluated with the single leg balance test with eyes open and closed.
Time Frame
8 weeks
Title
Pittsburgh Sleep Quality Index
Description
Sleep quality will be assessed by the Pittsburgh Sleep Quality Index.
Time Frame
8 weeks
Title
SF-36 (the MOS 36-item short-form health survey)
Description
As the general quality of life, the SF-36 (the MOS 36-item short-form health survey) form will be used.
Time Frame
8 weeks
Title
Plasma Fibrinogen and Haptoglobin Protein Levels
Description
Two plasma proteins, fibrinogen and haptoglobin, will be evaluated as markers of inflammation.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
To be between the ages of 18-65
Being diagnosed with FMS according to ACR 2010 criteria
To be diagnosed with FMS at least 6 months before the study
Reported pain intensity > 4 (Visual Analog Scale 0-10),
Individuals that do not have barriers to basic body awareness therapy.
Exclusion Criteria:
Pregnancy or intention to become pregnant within the study period.
Substance and alcohol abuse, major psychiatric disorder (preventing compliance), uncontrolled hypertension, diabetes, congestive heart failure, or other serious chronic medical condition that puts the patient at risk for the clinician to expose the patient to potentially serious consequences of their illness
Those who have malignancy and those receiving chemotherapy and radiotherapy causing malignancy
Those who have suffered from any musculoskeletal, neurological, rheumatological disorder or any condition that may interfere with evaluations (advanced respiratory or orthopedic problems such as fractures, sprains or strains, or spinal surgery) in the past 12 months -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Özge TAHRAN, MSc
Organizational Affiliation
Beykent University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beykent University
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Effects of Face-to-Face and Internet-Based BBAT in Fibromyalgia Syndrome
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