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Completed

NCT Number: NCT06415565

Investigation of the Effectiveness of Thoracic Mobilization Exercise in Fibromyalgia Patients

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uskudar Üniversity

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Physiotherapy

Other

Methods applied as conventional physiotherapy methods are: hotpack, Transcutaneous electrical nerve stimulation and ultrasound.

thoracic mobilization methods

Other

Methods applied as conventional physiotherapy methods: hotpack, Transcutaneous electrical nerve stimulation and ultrasound applications will be applied. Also within the scope of thoracic mobilization: thoracic region extension stretching in the kneeling position, thoracic flexion in the crawling position, halo exercise, thoracic rotation exercises in the crawling position, thoracic rotation in the side lying position. , quadruped extension and rotation exercises will be applied. Patients will be informed that these exercises can also be done as home exercises and they will be asked to practice for 8 weeks.

Primary outcomes

  1. Beck Depression Scale

    Time frame: 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.

  2. Beck Anxiety Scale

    Time frame: 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).

  3. Fibromyalgia Impact Survey

    Time frame: 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.

  4. Heart rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 16, 2024
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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