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

NCT04970511 | Completed

• 1 other identifier: BBAT
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• The Revised Fibromyalgia Impact Questionnaire (FIQR)

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

  8 weeks

Secondary Outcomes (10)

• Algometer

  8 weeks

• Posture Screen Mobile (PSM)

  8 weeks

• The short-form McGill Pain Questionnaire

  8 weeks

• Trunk repositioning error

  8 weeks

• Awareness-Body-Chart=ABC

  8 weeks

Study Arms (3)

The group I: BBAT Face-to-Face Training group

EXPERIMENTAL

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 II: Online BBAT training group

EXPERIMENTAL

Patients in the Internet-based BBAT 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 BBAT group.

Behavioral: Online BBAT training

The group III: Control group

NO INTERVENTION

No training will be applied to the control group patients.

Interventions

BBAT (Basic Body Awareness Therapy) BEHAVIORAL

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

The group I: BBAT Face-to-Face Training group

Online BBAT training BEHAVIORAL

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

The group II: Online BBAT training group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 -

Sponsors & Collaborators

• University of Beykent: lead

Study Sites (1)

Beykent University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Özge TAHRAN, MSc

  Beykent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc.,Physiotherapist, Lecturer

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 21, 2021
• Study Start: July 1, 2021
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: January 9, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)