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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04970511
Enrollment
41
Registered
2021-07-21
Start date
2021-07-01
Completion date
2022-12-20
Last updated
2025-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

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

Interventions

BEHAVIORALBBAT (Basic Body Awareness Therapy)

The group I: BBAT Face-to-Face Training (60 min) will be provided.

BEHAVIORALOnline BBAT training

The group II: Online BBAT training (60 min) will be provided.

Sponsors

University of Beykent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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 -

Design outcomes

Primary

MeasureTime frameDescription
The Revised Fibromyalgia Impact Questionnaire (FIQR)8 weeksLimitations and functional disability in patients with fibromyalgia will be evaluated.

Secondary

MeasureTime frameDescription
Posture Screen Mobile (PSM)8 weeksPosture will be evaluated with Posture Screen Mobile (PSM), an iPad application.
The short-form McGill Pain Questionnaire8 weeksPain will be evaluated with the short-form McGill Pain Questionnaire
Trunk repositioning error8 weeksThe trunk position sense indicated by trunk reposition errors will be evaluated with the inclinometer device.
Awareness-Body-Chart=ABC8 weeksAwareness-Body-Chart=ABC will be used to assess body awareness.
Algometer8 weeksPressure pain threshold measurement of characteristic 18 tender points of fibromyalgia syndrome will be performed.
Single Leg Balance8 weeksBalance will be evaluated with the single leg balance test with eyes open and closed.
Pittsburgh Sleep Quality Index8 weeksSleep quality will be assessed by the Pittsburgh Sleep Quality Index.
SF-36 (the MOS 36-item short-form health survey)8 weeksAs 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 Levels8 weeksTwo plasma proteins, fibrinogen and haptoglobin, will be evaluated as markers of inflammation.
Postural stability8 weeksPostural stability will be evaluated with a portable force platform.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026