Clinical trial NCT06378788: Muscle Architecture and Muscle Strength in Fibromyalgia
Official title: Ultrasound-imaged Muscle Architecture and Muscle Strength in Fibromyalgia and it's Correlation With Pain, Disease Activity, and Functionality
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fibromyalgia
Sarcopenia
Muscle Weakness
Keywords: muscle strength
musculoskeletal ultrasound
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fisrt group: Fibromyalgia diagnosed patient group Second group: Healthy control group

Brief summary: The goal of this observational study is to determine whether there is decrease in muscle mass and muscle strength in Fibromyalgia Syndrome (FMS) patients in comparison to controls. And to determine whether these parameters are correlated with clinical ones. Briefly the main questions investigators aims to answer are:

* Is there a significant difference in muscle morphology between FMS and controls?
* Is there a significant difference in muscle strength between FMS and controls?
* Is there a relationship between muscle thickness and pennation angle of the Quadriceps, gastrocnemius medialis, gastrocnemius lateralis and Tibialis anterior muscles and disease activity, pain and functionality?
* Is there a correlation between muscle strength in FMS and disease activity, pain and functionality?

Detailed description: Fibromyalgia syndrome (FMS) was named by Smythe and Moldofsky when they defined tender points in 1970s. It is defined as chronic, generalized musculoskeletal pain accompanying with fatigue, sleep disturbance , cognitive and somatic disturbance. FMS has variable prevalence as %0,7-11 and usually affects middle aged women. It is second most common rheumatologic disease after osteoarthritis and thought to be the most common reason for musculoskeletal pain in middle aged women.

Recent studies have reported that both sarcopenia and decreased muscle strength occur in patients with chronic inflammatory diseases such as rheumatoid arthritis. There are concerns that sarcopenia may affect exercise tolerance, activities of daily living, and ultimately have a negative impact on cardiovascular fitness and physical and emotional well-being. On the other hand there is researches that support inflammation-driven pathways in the pathogenesis of fibromyalgia. Given the risk of pain related reduction in physical activity, patients are expected to have accelerated muscle wasting , decreased muscle strength and endurance and functionality.

However, there is no study that focused on muscle architecture and strength in FMS. This led us to design our study which will evaluate patients lower extremity muscles' thickness and pennation angles by ultrasound , most daily used muscles' strength by dynamometer, functionality by timed-up test and try to find whether there is a correlation between these parameters and patients' disease activity which will be determined with FMS specific scales.

Eligibility criteria: Inclusion Criteria:

* Meeting the 2016 ACR (American College of Rheumatology) diagnostic criteria.
* Diagnosed at least 1 year ago.

Exclusion Criteria:

* Patients diagnosed with other rheumatological diseases, muscle diseases, or neuropathies.
* Patients with a history of trauma affecting muscle morphology.
* Patients engaging in regular exercise (at least 3-4 times a week for a minimum of 40 minutes).
* Patients with uncontrolled comorbid diseases

Primary outcomes:
measure: Quadriceps Femoris Vastus Lateralis Muscle Thickness
timeFrame: through study completion, an average of 16 weeks
measure: Quadriceps Femoris Vastus Lateralis Fascicle Length
timeFrame: through study completion, an average of 16 weeks
measure: Quadriceps Femoris Vastus Medialis Muscle Thickness
timeFrame: through study completion, an average of 16 weeks
measure: Quadriceps Femoris Vastus Medialis Fascicle Length
timeFrame: through study completion, an average of 16 weeks
measure: Quadriceps Femoris Rectus Femoris Muscle Thickness
timeFrame: through study completion, an average of 16 weeks
measure: Quadriceps Femoris Rectus Femoris Fascicle Length
timeFrame: through study completion, an average of 16 weeks
measure: Tibialis Anterior Muscle Thickness
timeFrame: through study completion, an average of 16 weeks
measure: Tibialis Anterior Muscle Fascicle Length
timeFrame: through study completion, an average of 16 weeks
measure: Gastrocnemius Muscle Vastus Medialis Muscle Thickness
timeFrame: through study completion, an average of 16 weeks
measure: Gastrocnemius Muscle Vastus Medialis Fascicle Length
timeFrame: through study completion, an average of 16 weeks
measure: Gastrocnemius Muscle Vastus Lateralis Muscle Thickness
timeFrame: through study completion, an average of 16 weeks
measure: Gastrocnemius Muscle Vastus Lateralis Fascicle Length
timeFrame: through study completion, an average of 16 weeks
measure: Cervical Muscle strength
timeFrame: through study completion, an average of 16 weeks
measure: Truncal Muscle strength
timeFrame: through study completion, an average of 16 weeks
measure: Shoulder Muscle strength
timeFrame: through study completion, an average of 16 weeks
measure: Hip Muscle strength
timeFrame: through study completion, an average of 16 weeks
measure: Knee Muscle strength
timeFrame: through study completion, an average of 16 weeks
measure: Ankle Muscle strength
timeFrame: through study completion, an average of 16 weeks
measure: Timed Up & Go (TUG)
timeFrame: through study completion, an average of 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
state: Fatih
Study officials:
affiliation: Bezmialem VU
name: Delal Ozturk, Res.Ass
role: PRINCIPAL_INVESTIGATOR
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