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

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ClinicalTrials.gov Identifier: NCT04970511
Recruitment Status : Enrolling by invitation
First Posted : July 21, 2021
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
Özge Tahran, 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 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.


Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: BBAT (Basic Body Awareness Therapy) Behavioral: Online BBAT training Not Applicable

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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Effects of Face-to-Face and Internet-Based Basic Body Awareness Therapy in Fibromyalgia Syndrome
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : July 20, 2023
Estimated Study Completion Date : July 20, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: The group I: BBAT Face-to-Face Training group

Exercises consist of supine, sitting, standing position awareness exercises and walking exercises.

Considering eight weeks, the training is designed to progress gradually each week.

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

Experimental: The group II: Online BBAT training group

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.

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

No Intervention: The group III: Control group
No training will be applied to the control group patients.



Primary Outcome Measures :
  1. The Revised Fibromyalgia Impact Questionnaire (FIQR) [ Time Frame: 8 weeks ]
    Limitations and functional disability in patients with fibromyalgia will be evaluated.

  2. Algometer [ Time Frame: 8 weeks ]
    Pressure pain threshold measurement of characteristic 18 tender points of fibromyalgia syndrome will be performed.

  3. Awareness-Body-Chart=ABC [ Time Frame: 8 weeks ]
    Awareness-Body-Chart=ABC will be used to assess body awareness.

  4. Posture Screen Mobile (PSM) [ Time Frame: 8 weeks ]
    Posture will be evaluated with Posture Screen Mobile (PSM), an iPad application.


Secondary Outcome Measures :
  1. The short-form McGill Pain Questionnaire [ Time Frame: 8 weeks ]
    Pain will be evaluated with the short-form McGill Pain Questionnaire

  2. Trunk repositioning error [ Time Frame: 8 weeks ]
    The trunk position sense indicated by trunk reposition errors will be evaluated with the inclinometer device.

  3. Postural stability [ Time Frame: 8 weeks ]
    Postural stability will be evaluated with a portable force platform.

  4. Single Leg Balance [ Time Frame: 8 weeks ]
    Balance will be evaluated with the single leg balance test with eyes open and closed.

  5. Pittsburgh Sleep Quality Index [ Time Frame: 8 weeks ]
    Sleep quality will be assessed by the Pittsburgh Sleep Quality Index.

  6. 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.

  7. Plasma Fibrinogen and Haptoglobin Protein Levels [ Time Frame: 8 weeks ]
    Two plasma proteins, fibrinogen and haptoglobin, will be evaluated as markers of inflammation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04970511


Locations
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Turkey
Beykent University
Istanbul, Turkey
Sponsors and Collaborators
University of Beykent
Investigators
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Principal Investigator: Özge TAHRAN, MSc Beykent University
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Responsible Party: Özge Tahran, MSc.,Physiotherapist, Lecturer, University of Beykent
ClinicalTrials.gov Identifier: NCT04970511    
Other Study ID Numbers: BBAT
First Posted: July 21, 2021    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases