Investigation of the Effectiveness of Thoracic Mobilization Exercise in Fibromyalgia Patients

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Other: conventional physiotherapy; Other: thoracic mobilization methods

• Registration Number: NCT06415565
• Lead Sponsor: Uskudar University

Brief Summary

The aim of this study is to investigate the effects of mobilization exercises applied to the thoracic region on pain, anxiety, depression, disease impact questionnaire, sympathetic and parasympathetic activity in patients diagnosed with fibromyalgia.

Detailed Description

The patients included in the study were randomly divided into two as Thoracic Mobilization Group and Control Group and will be included in the treatment programs after the initial evaluations. Patients in both groups will receive a treatment of 11 sessions in total, 5 sessions per week. Participants will be evaluated twice before and after treatment with the Fibromyalgia impact questionnaire, Beck anxiety and Beck depression questionnaires. In addition, the E-motion Faros device will be used to measure heart rate variability. Measurements of heart rate variables will be made before and after the first day of treatment, before and after the 11th session, and on the 45th day.

Study Timeline

• Study First Submitted: 2024-05-09
• Study First Submitted QC: 2024-05-09
• Study Start: 2024-05-15
• Study First Posted: 2024-05-16
• Status Verified: 2024-07
• Primary Completion: 2024-07-19
• Study Completion: 2024-07-19
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Being diagnosed with fibromyalgia by a specialist physician according to the 2013 American Association of Rheumatology diagnostic criteria
• Being between the ages of 18-45

Exclusion Criteria

• Those with neurological deficit
• During menopause and postmenstrual period
• Diagnosed with diabetes
• Those with neuropathic disease
• Those with chronic inflammation
• Have immunodeficiency
• Those with cardiac disease
• Patients who are pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	conventional physiotherapy	Conventional physiotherapy practices will be performed.
mobilization	thoracic mobilization methods	In addition to conventional physiotherapy applications, thoracic mobilization applications will be performed.
mobilization	conventional physiotherapy	In addition to conventional physiotherapy applications, thoracic mobilization applications will be performed.

Primary Outcome Measures

Name	Time	Method
Beck Anxiety Scale	8 weeks	The Beck Anxiety Scale is a self-report questionnaire that measures 21 common somatic and cognitive symptoms of anxiety. Beck Anxiety Scale has 21 questions, each question scored between 0 and 3. The total score to be obtained from the scale varies between 0-63. Beck Anxiety Scale scores are classified as minimal anxiety (0 to 7), mild anxiety (8 to 15), moderate anxiety (16 to 25), and severe anxiety (30 to 63).
Beck Depression Scale	8 weeks	The Beck Depression Scale is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. The 21 questions in the Beck Depression Scale reflect the symptoms, attitudes and intensity of depression; Items receive a score between zero and three. The total score ranges from 0 to 63. Scores from 0 to 9 indicate no or minimal depression; Scores from 10 to 18 indicate mild to moderate depression; Scores from 19 to 29 indicate moderate to severe depression, and scores from 30 to 63 indicate severe depression.
Fibromyalgia Impact Survey	8 weeks	The Fibromyalgia Impact Questionnaire is an assessment tool developed to measure the condition, progress and outcomes of fibromyalgia patients. It is designed to measure the health status components believed to be most affected in fibromyalgia. Fibromyalgia Impact Questionnaire consists of 10 items. The maximum possible score for each of the 10 items is 10. Therefore the maximum possible score is 100. The average fibromyalgia patient's score is around 50, with severely affected patients often scoring above 70.
Heart rate	8 weeks	The E-motion Faros device will be used to measure heart rate variability. E-motion Faros is a 3-electrode device that measures heart rate changes. Two of the electrodes in the device are placed under the patient's right and left clavicle, and the other one is placed just above the lowest left rib. Electrocardiogram measurement takes an average of 5 minutes.

Trial Locations

Locations (1)

Uskudar Üniversity; 🇹🇷 Istanbul, Turkey