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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04970511
• Other study ID #: BBAT
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: November 2023
• Source: University of Beykent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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: 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. To be between the ages of 18-65

2. Being diagnosed with FMS according to ACR 2010 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 -

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• BBAT (Basic Body Awareness Therapy)
The group I: BBAT Face-to-Face Training (60 min) will be provided.
• Online BBAT training
The group II: Online BBAT training (60 min) will be provided.

Locations

Country	Name	City	State
Turkey	Beykent University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
University of Beykent

Country where clinical trial is conducted

Turkey, 

Outcome

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