The Efficacy of a Telerehabilitation Pilates Program in Fibromyalgia Syndrome Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia Syndrome
• Intervention / Treatment: Other: Exercise

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey
    • Necmettin Erbakan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group	Other: Exercise; Clinical pilates program
Active Comparator: Telerehabilitation group	Other: Exercise; Clinical pilates program
No Intervention: Healthy Control Group; The first results were compared

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasonographic assessment	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.	First day (at beginning) and last day (8. weeks)
McGill core endurance tests	The lumbopelvic stability was conducted using McGill core endurance tests, which included tests for trunk flexion, extension, and right and left lateral flexion endurance.	First day (at beginning) and last day (8. weeks)
Fibromyalgia Impact Questionnaire	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.	First day (at beginning) and last day (8. weeks)
Fatigue Severity Scale	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.	First day (at beginning) and last day (8. weeks)
Central Sensitization Inventory Short-Form	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.	First day (at beginning) and last day (8. weeks)
Hospital Anxiety and Depression Scale	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.	First day (at beginning) and last day (8. weeks)
Numeric Rating Scale	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.	First day (at beginning) and last day (8. weeks)

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2024
• Primary Completion (Actual): August 15, 2024
• Study Completion (Actual): November 20, 2024

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Telemedicine; Pain; Telehealth; Fibromyalgia
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Pathologic Processes; Neuromuscular Diseases; Rheumatic Diseases; Disease; Syndrome; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 2024/5012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No