Isokinetic Muscle Strength, Torque, Ultrasonographic Muscle Thickness in Fibromyalgia Syndrome: A Case-Control Study

NCT07649824 | Completed

• 1 other identifier: SBA 24/516
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Fibromyalgia syndrome (FMS) is a chronic disease characterized by widespread body pain and tenderness in specific points, which may be accompanied by sleep disturbances, depression, fatigue, cognitive symptoms such as memory problems and attention deficit, and somatic symptoms such as irritable bowel syndrome and constipation. The prevalence of FMS has been found to be approximately 2%. It is more frequently diagnosed in women between the ages of thirty and fifty . It is more common in individuals with low socioeconomic status and education level. Its etiology is not fully known. Genetic and some environmental factors are thought to be influential. Central sensitization, autonomic nervous system dysfunction, immune system dysregulation, intestinal microbiota changes, hypothalamic-pituitary-adrenal (HPA) axis and endocrine system disorders are implicated in the pathogenesis (5; 6; 7; 8). FMS diagnostic criteria were first established in 1990 by the American College of Rheumatology (ACR). According to these criteria, FMS is diagnosed based on the presence of widespread pain and tender points in the body. In 2010, the ACR updated the diagnostic criteria by adding the Widespread Pain Index and Symptom Severity Scale. Currently, the 2016 ACR classification criteria are used in the diagnosis of FMS. These criteria consider the presence of pain for at least 3 months, the widespread pain index which assesses the presence of pain in 5 different areas of the body, and the symptom severity scale which assesses fatigue, waking up without rest, and cognitive symptoms. In these criteria, a diagnosis of fibromyalgia can be made independently of other diagnoses; the presence of fibromyalgia does not rule out the presence of other diseases. The treatment approach for FMS is multidisciplinary. It is considered both non-pharmacological and pharmacological. Non-pharmacological treatment consists of patient education, lifestyle modification, cognitive behavioral therapy, and exercise. Pharmacological treatment includes tricyclic antidepressants, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and pregabalin. The aim of the study is to evaluate muscle strength, muscle power, muscle thickness, vitamin D levels, and sleep quality in individuals with and without fibromyalgia syndrome, and to identify possible risk factors.

Conditions

Fibromyalgia; Chronic Pain Syndrome; Muscle Thinning; Sleep; Vitamin D3

Outcome Measures

Primary Outcomes (3)

• Isokinetic Muscle Strength Assessment

  An isokinetic computerized dynamometer system will be used to measure muscle strength in the dominant knee in both patient and control groups. Strenght (torque) will be measured and recorded in Newton-meters at a speed of 60 degrees per second for 5 repetitions.

  Baseline

• Ultrasound Assessment of Muscle Thickness

  For the ultrasonographic evaluation, a 5-12 MHz linear probe was used. Measurements were taken using standard USG gel. While participants lay supine with their knees fully extended, the distance between the anterior superior iliac spine (SIAS) and the superior aspect of the patella was measured and half of this measurement was marked. The thickness of the quadriceps femoris muscles (M. vastus intermedius and M. rectus femoris) was then measured by holding the USG probe axially without applying pressure.Measurements will be recorded in millimeters.

  Baseline

• Isokinetic Muscle Power Assessment

  An isokinetic computerized dynamometer system will be used to measure muscle power in the dominant knee in both patient and control groups. Power will be measured and recorded in Watts at 180 degrees/second for 15 repetitions.

  Baseline

Secondary Outcomes (3)

• Measuring Serum Vitamin D Levels

  Baseline

• Assessment of Sleep Quality

  Baseline

• Assessment of Fibromyalgia Syndrome Disease Severity

  Baseline

Study Arms (2)

Fibromyalgia

Women aged 18-55 who have been diagnosed with fibromyalgia syndrome within the last 3 months according to the 2016 ACR Fibromyalgia Syndrome Diagnostic Criteria and the system has a 25 OH vitamin D measurement result.

Control

Healthy women aged 18-55 and the system has a 25 OH vitamin D measurement result.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Only female individuals
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The case group consisted of 40 volunteer female patients who presented to the outpatient clinic of the university hospital, agreed to participate in the study, were diagnosed with fibromyalgia syndrome, and met the inclusion criteria. The control group consisted of 40 healthy female volunteers who did not have a diagnosis of fibromyalgia syndrome

You may qualify if:

• Patient group:
• female gender
• years old
• Clinical diagnosis of Fibromyaljia syndrome
• Control group:
• female gender
• years old
• absence of fibromyalgia syndrome diagnosis

You may not qualify if:

• Rheumatological disease, crystal arthropathy, septic arthritis
• Advanced osteoarthritis
• History of major orthopedic surgery (total knee and hip replacement, etc.)
• Neurological disease (Parkinson's disease, multiple sclerosis, cerebrovascular event, etc.)
• Neuromuscular disease (Polyneuropathies, myasthenia gravis)
• Active malignancy
• Advanced organ failure/transplantation

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Kırşehir Ahi Evran University Faculty of Medicine

Kırşehir, City Center, 40100, Turkey (Türkiye)

Location

Related Publications (2)

• Rodriguez-Dominguez AJ, Rebollo-Salas M, Chillon-Martinez R, Rosales-Tristancho A, Villa-Del-Pino I, Jimenez-Rejano JJ. The most effective therapeutic exercises for pain intensity in women with fibromyalgia: A systematic review and network meta-analysis. Braz J Phys Ther. 2025 Jul-Aug;29(4):101226. doi: 10.1016/j.bjpt.2025.101226. Epub 2025 May 3.

  PMID: 40319533 BACKGROUND

• Mesci E, Dogruoz B, Mesci N, Icagasioglu A. Ultrasonographic evaluation of muscle thickness in female patients with fibromyalgia and its relationship with clinical parameters. North Clin Istanb. 2023 Nov 27;10(6):718-725. doi: 10.14744/nci.2023.04382. eCollection 2023.

  PMID: 38328726 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Muscular Atrophy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Basak Cigdem Karacay, Assoc Prof

  Kirsehir Ahi Evran Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assoc. Professor

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 16, 2026
• Study Start: April 1, 2024
• Primary Completion: January 25, 2025
• Study Completion: January 25, 2025
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

TU (1)