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

NCT ID: NCT04970511

Last Updated: 2025-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-12-20

Brief Summary

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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

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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

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

BBAT (Basic Body Awareness Therapy)

Intervention Type BEHAVIORAL

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

The group II: Online BBAT training group

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.

Group Type EXPERIMENTAL

Online BBAT training

Intervention Type BEHAVIORAL

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

The group III: Control group

No training will be applied to the control group patients.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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BBAT (Basic Body Awareness Therapy)

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

Intervention Type BEHAVIORAL

Online BBAT training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Beykent

OTHER

Sponsor Role lead

Responsible Party

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Özge Tahran

MSc.,Physiotherapist, Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Özge TAHRAN, MSc

Role: PRINCIPAL_INVESTIGATOR

Beykent University

Locations

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Beykent University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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BBAT

Identifier Type: -

Identifier Source: org_study_id

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