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Clinical Trials/NCT04970511
NCT04970511
Completed
Not Applicable

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

University of Beykent1 site in 1 country41 target enrollmentJuly 1, 2021
ConditionsFibromyalgia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fibromyalgia
Sponsor
University of Beykent
Enrollment
41
Locations
1
Primary Endpoint
The Revised Fibromyalgia Impact Questionnaire (FIQR)
Status
Completed
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
July 1, 2021
End Date
December 20, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Beykent
Responsible Party
Principal Investigator
Principal Investigator

Özge Tahran

MSc.,Physiotherapist, Lecturer

University of Beykent

Eligibility Criteria

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 -

Outcomes

Primary Outcomes

The Revised Fibromyalgia Impact Questionnaire (FIQR)

Time Frame: 8 weeks

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

Secondary Outcomes

  • 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)
  • Postural stability(8 weeks)
  • Single Leg Balance(8 weeks)
  • Pittsburgh Sleep Quality Index(8 weeks)
  • SF-36 (the MOS 36-item short-form health survey)(8 weeks)
  • Plasma Fibrinogen and Haptoglobin Protein Levels(8 weeks)

Study Sites (1)

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