Comparison of the Effects of Face-to-Face and Internet-Based BBAT in Fibromyalgia Syndrome

Comparison of the Effects of Face-to-Face and Internet-Based Basic Body Awareness Therapy in Fibromyalgia Syndrome

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 BBAT have superiority over each other in patients diagnosed with Fibromyalgia Syndrome.

H1: In patients diagnosed with Fibromyalgia Syndrome, face-to-face and internet-based BBAT have no superiority over each other.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: BBAT (Basic Body Awareness Therapy); Behavioral: Online BBAT training

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 BBAT have superiority over each other in patients diagnosed with Fibromyalgia Syndrome.

H1: In patients diagnosed with Fibromyalgia Syndrome, face-to-face and internet-based BBAT have no superiority over each other.

Goals:

1. 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.
2. 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

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Beykent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. To be between the ages of 18-65
2. Being diagnosed with FMS according to ACR 2016 criteria
3. To be diagnosed with FMS at least 6 months before the study
4. Reported pain intensity > 4 (Visual Analog Scale 0-10),
5. Individuals that do not have barriers to basic body awareness therapy.

Exclusion Criteria:

1. Pregnancy or intention to become pregnant within the study period.
2. 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
3. Those who have malignancy and those receiving chemotherapy and radiotherapy causing malignancy
4. 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 -

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The group I: BBAT Face-to-Face Training group; Exercises consist of supine, sitting, standing position awareness exercises and walking exercises. Considering eight weeks, the training is designed to progress gradually each week.	Behavioral: BBAT (Basic Body Awareness Therapy); The group I: BBAT Face-to-Face Training (60 min) will be provided.
No Intervention: The group III: Control group; No training will be applied to the control group patients.
Experimental: The group II: Online BBAT training group; Patients in the Internet-based BBAT 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 BBAT group.	Behavioral: Online BBAT training; The group II: Online BBAT training (60 min) will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Revised Fibromyalgia Impact Questionnaire (FIQR)	Limitations and functional disability in patients with fibromyalgia will be evaluated.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Algometer	Pressure pain threshold measurement of characteristic 18 tender points of fibromyalgia syndrome will be performed.	8 weeks
Awareness-Body-Chart=ABC	Awareness-Body-Chart=ABC will be used to assess body awareness.	8 weeks
Posture Screen Mobile (PSM)	Posture will be evaluated with Posture Screen Mobile (PSM), an iPad application.	8 weeks
The short-form McGill Pain Questionnaire	Pain will be evaluated with the short-form McGill Pain Questionnaire	8 weeks
Trunk repositioning error	The trunk position sense indicated by trunk reposition errors will be evaluated with the inclinometer device.	8 weeks
Postural stability	Postural stability will be evaluated with a portable force platform.	8 weeks
Single Leg Balance	Balance will be evaluated with the single leg balance test with eyes open and closed.	8 weeks
Pittsburgh Sleep Quality Index	Sleep quality will be assessed by the Pittsburgh Sleep Quality Index.	8 weeks
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.	8 weeks
Plasma Fibrinogen and Haptoglobin Protein Levels	Two plasma proteins, fibrinogen and haptoglobin, will be evaluated as markers of inflammation.	8 weeks

Collaborators and Investigators

• Sponsor: University of Beykent
• Investigators: Principal Investigator: Özge TAHRAN, MSc, Beykent University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: July 10, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: BBAT

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
• product manufactured in and exported from the U.S.: No