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NCT Number: NCT04970511

Comparison of the Effects of Face-to-Face and Internet-Based BBAT 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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beykent University

Istanbul, Turkey (Türkiye)

About this study

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:

  • 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.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

BBAT (Basic Body Awareness Therapy)

Behavioral

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

Online BBAT training

Behavioral

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

Primary outcomes

  1. The Revised Fibromyalgia Impact Questionnaire (FIQR)

    Time frame: 8 weeks

    Limitations and functional disability in patients with fibromyalgia will be evaluated.

Secondary outcomes

  1. Algometer

    Time frame: 8 weeks

    Pressure pain threshold measurement of characteristic 18 tender points of fibromyalgia syndrome will be performed.

  2. Posture Screen Mobile (PSM)

    Time frame: 8 weeks

    Posture will be evaluated with Posture Screen Mobile (PSM), an iPad application.

  3. The short-form McGill Pain Questionnaire

    Time frame: 8 weeks

    Pain will be evaluated with the short-form McGill Pain Questionnaire

  4. Trunk repositioning error

    Time frame: 8 weeks

    The trunk position sense indicated by trunk reposition errors will be evaluated with the inclinometer device.

  5. Awareness-Body-Chart=ABC

    Time frame: 8 weeks

    Awareness-Body-Chart=ABC will be used to assess body awareness.

  6. Postural stability

    Time frame: 8 weeks

    Postural stability will be evaluated with a portable force platform.

  7. Single Leg Balance

    Time frame: 8 weeks

    Balance will be evaluated with the single leg balance test with eyes open and closed.

  8. Pittsburgh Sleep Quality Index

    Time frame: 8 weeks

    Sleep quality will be assessed by the Pittsburgh Sleep Quality Index.

  9. SF-36 (the MOS 36-item short-form health survey)

    Time frame: 8 weeks

    As the general quality of life, the SF-36 (the MOS 36-item short-form health survey) form will be used.

  10. Plasma Fibrinogen and Haptoglobin Protein Levels

    Time frame: 8 weeks

    Two plasma proteins, fibrinogen and haptoglobin, will be evaluated as markers of inflammation.

Sponsors and collaborators

Lead sponsor

University of Beykent

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2021
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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