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Completed

NCT Number: NCT06791954

The Efficacy of a Telerehabilitation Pilates Program in Fibromyalgia Syndrome Patients

The study aims to evaluate the effects of a telerehabilitation-based clinical pilates program in patients with fibromyalgia syndrome. A randomized controlled trial was designed. An online clinical Pilates-based exercise program targeting stability and strength that was conducted for 8 weeks with 2 sessions per week was developed for the telerehabilitation group. The same exercise programs for the control group were provided in brochures.

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Key information

Conditions

Fibromyalgia Syndrome Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan University

Konya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Diagnosis of FMS at least one year before the study
  • Stable general health condition for the past 6 months

Exclusion criteria

  • Inability to cooperate with measurements
  • Regular engagement in exercise

Treatment and study plan

Exercise

Other

Clinical pilates program

Primary outcomes

  1. Ultrasonographic assessment

    Time frame: First day (at beginning) and last day (8. weeks)

    A 9 MHz linear probe was utilized to determine the transversus abdominis, external oblique, and internal oblique muscles. For the ultrasonographic evaluation of the lumbar multifidus muscles, subjects were positioned in supine and prone positions. A 1.5-6 MHz convex probe was initially placed in a transverse orientation to cover the L4-L5-S1 anatomical region.

  2. McGill core endurance tests

    Time frame: First day (at beginning) and last day (8. weeks)

    The lumbopelvic stability was conducted using McGill core endurance tests, which included tests for trunk flexion, extension, and right and left lateral flexion endurance.

  3. Fibromyalgia Impact Questionnaire

    Time frame: First day (at beginning) and last day (8. weeks)

    The Fibromyalgia Impact Questionnaire (FIQ) is a measure consisting of 10 items that assess physical function, work status, productivity level, depression, anxiety, sleep, pain, stiffness, fatigue, and overall well-being. Higher scores indicate higher disease activity.

  4. Fatigue Severity Scale

    Time frame: First day (at beginning) and last day (8. weeks)

    Fatigue Severity Scale (FSS) consists of a total of nine items. Each item is scored on a scale from 1 to 7. An increase in the total score indicates a higher level of fatigue severity.

  5. Central Sensitization Inventory Short-Form

    Time frame: First day (at beginning) and last day (8. weeks)

    Central Sensitization Inventory Short Form (CSI-SF) is designed to assess the presence of central sensitization and associated symptoms. The total score ranges from 0 to 36, with higher scores indicating greater severity of central sensitization.

  6. Hospital Anxiety and Depression Scale

    Time frame: First day (at beginning) and last day (8. weeks)

    The Hospital Anxiety and Depression Scale comprises 14 items. Odd-numbered items assess anxiety, while even-numbered items evaluate depression. The lowest possible score for each subscale is 0, and the highest is 21.

  7. Numeric Rating Scale

    Time frame: First day (at beginning) and last day (8. weeks)

    The Pain Numeric Rating Scale is a numerical version of the visual analog scale, where patients are asked to indicate the number that best reflects their pain severity on a scale from 0 to 10.

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

The Efficacy of a Telerehabilitation Pilates Program on Lumbopelvic Muscle Morphology in Patients With Fibromyalgia Syndrome

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 24, 2025
Registry last updated
Jan 24, 2025

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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