Clinical trial NCT04970511: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: University of Beykent
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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 -

Primary outcomes:
measure: The Revised Fibromyalgia Impact Questionnaire (FIQR)
timeFrame: 8 weeks
Secondary outcomes:
measure: Algometer
timeFrame: 8 weeks
measure: Posture Screen Mobile (PSM)
timeFrame: 8 weeks
measure: The short-form McGill Pain Questionnaire
timeFrame: 8 weeks
measure: Trunk repositioning error
timeFrame: 8 weeks
measure: Awareness-Body-Chart=ABC
timeFrame: 8 weeks
measure: Postural stability
timeFrame: 8 weeks
measure: Single Leg Balance
timeFrame: 8 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 8 weeks
measure: SF-36 (the MOS 36-item short-form health survey)
timeFrame: 8 weeks
measure: Plasma Fibrinogen and Haptoglobin Protein Levels
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beykent University
Study officials:
affiliation: Beykent University
name: Özge TAHRAN, MSc
role: PRINCIPAL_INVESTIGATOR
References: