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

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Behavioral: Online BBAT training; Behavioral: BBAT (Basic Body Awareness Therapy)

• Registration Number: NCT04970511
• Lead Sponsor: University of Beykent

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 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.

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 Timeline

• Study First Submitted: 2021-06-28
• Study Start: 2021-07-01
• Study First Submitted QC: 2021-07-10
• Study First Posted: 2021-07-21
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-20
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The group II: Online BBAT training group	Online BBAT training	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.
The group I: BBAT Face-to-Face Training group	BBAT (Basic Body Awareness Therapy)	Exercises consist of supine, sitting, standing position awareness exercises and walking exercises. Considering eight weeks, the training is designed to progress gradually each week.

Primary Outcome Measures

Name	Time	Method
The Revised Fibromyalgia Impact Questionnaire (FIQR)	8 weeks	Limitations and functional disability in patients with fibromyalgia will be evaluated.

Secondary Outcome Measures

Name	Time	Method
Algometer	8 weeks	Pressure pain threshold measurement of characteristic 18 tender points of fibromyalgia syndrome will be performed.
Posture Screen Mobile (PSM)	8 weeks	Posture will be evaluated with Posture Screen Mobile (PSM), an iPad application.
The short-form McGill Pain Questionnaire	8 weeks	Pain will be evaluated with the short-form McGill Pain Questionnaire
Trunk repositioning error	8 weeks	The trunk position sense indicated by trunk reposition errors will be evaluated with the inclinometer device.
Awareness-Body-Chart=ABC	8 weeks	Awareness-Body-Chart=ABC will be used to assess body awareness.
Postural stability	8 weeks	Postural stability will be evaluated with a portable force platform.
Single Leg Balance	8 weeks	Balance will be evaluated with the single leg balance test with eyes open and closed.
Pittsburgh Sleep Quality Index	8 weeks	Sleep quality will be assessed by the Pittsburgh Sleep Quality Index.
SF-36 (the MOS 36-item short-form health survey)	8 weeks	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	8 weeks	Two plasma proteins, fibrinogen and haptoglobin, will be evaluated as markers of inflammation.

Trial Locations

Locations (1)

Beykent University; 🇹🇷 Istanbul, Turkey