Muscle Architecture and Muscle Strength in Fibromyalgia

Ultrasound-imaged Muscle Architecture and Muscle Strength in Fibromyalgia and it's Correlation With Pain, Disease Activity, and Functionality

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?

Study Overview

• Status: Recruiting
• Conditions: Muscle Weakness; Fibromyalgia; Sarcopenia
• Intervention / Treatment: Other: Demographic information form; Diagnostic test: widespread pain index (WPI); Diagnostic test: symptom severity scale (SSS); Diagnostic test: Fibromyalgia Impact Questionnaire (FIQ); Diagnostic test: Tender Point examination; Other: Muscle Architecture visualized with ultrasound; Other: Sarcopenia assessed by measuring isometric strengths of different parts of the body; Other: Timed Up & Go (TUG)

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Delal Ozturk, Res.Ass; Phone Number: +902124530453; Email: drdelalozturk@gmail.com

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34093
      • Recruiting
      • Bezmialem Vakif University
      • Contact: Mehmet Serkan Kılıçoğlu, Ass.Prof.; Phone Number: +902124530453; Email: drserkankilicoglu@yahoo.com
      • Contact: Delal Ozturk, Res.Ass.; Phone Number: +902124530453; Email: drdelalozturk@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Fisrt group: Fibromyalgia diagnosed patient group Second group: Healthy control group

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fibromyalgia; Patients meeting the diagnostic criteria of 2016 American College of Rheumatology (ACR) guide for fibromyalgia	Other: Demographic information form; aims to collect basic demographic data( Age reported by years , weight and height will be combined to report Body Mass index (BMİ) in kg/m2, Smoking habit reported as smoker or non-smoker , Level of Education reported as illiterate, literate, Primary school, Middle school, High school, University or Post-graduate, Profession type, Significant medical records and Medications.; Diagnostic test: widespread pain index (WPI); The Widespread Pain Index is a 19-point checklist that assesses the presence of pain or tenderness (within the prior seven days) in 19 specific areas of the body; each affected area receives one point. The 19 regions on the WPI include the following: Right and left jaw, Right and left shoulder girdle, Right and left upper arm, Right and left lower arm, Right and left hip/buttock Right and left upper leg Right and left lower leg Upper and lower back Neck Chest Abdomen A fibromyalgia diagnosis is confirmed if a WPI is ≥7 with an SS scale ≥5 OR a WPI range between 4-6 with an SS scale ≥ 9.; Diagnostic test: symptom severity scale (SSS); SS scale score: Fatigue, waking unrefreshed, and cognitive symptoms. For each of the three symptoms above, indicate the severity level over the past week utilizing the following scale: 0 no problem; 1 slight or mild problems, generally mild or intermittent; 2 moderate, considerable problems, often present and/or at a moderate level; 3 severe: pervasive, continuous, life-disturbing problems. Considering somatic symptoms in general, indicate whether the patient has: 0 for no symptoms, 1 for a few symptoms, 2 for a moderate number of symptoms, and 3 for many symptoms. The SS scale score sums the severity of the 3 symptoms (fatigue, waking unrefreshed, cognitive symptoms) plus the severity) of general somatic symptoms. The final score is between 0 and 12.; Diagnostic test: Fibromyalgia Impact Questionnaire (FIQ); The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes. The FIQ is composed of 10 items. The first item contains 11 questions related to physical functioning - each question is rated on a 4 point Likert type scale. Items 2 and 3 ask the patient to mark the number of days they felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. Items 4 through 10 are horizontal linear scales marked in 10 increments on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety and depression.; Diagnostic test: Tender Point examination; Tender points are specific sites on the body that cause pain when pressed.. There are 9 pairs of tender points. Each pair has one point on each side of the body, for a total of 18 points.Prior to 2010, the diagnosis of fibromyalgia required at least 11 painful point of 18 but now tender points are no longer used as a diagnostic tool. The score will be reported as the number of tender points found with palpation.; Other: Muscle Architecture visualized with ultrasound; The three head of Quadratus femoris ( Vastus lateralis, Vastus Medialis and Rectus Femoris), Tibialis Anterior, the two heads of Gastrocnemius ( vastus Lateralis and vastus Medialis) ultrasonography will be performed to evaluate muscle thickness, pennation angle and fascicle length.; Other: Sarcopenia assessed by measuring isometric strengths of different parts of the body; Cervical Flexion (CF), Cervical Extension (CE), Right and Left Cervical Lateral Flexion (CLF R/L), Truncal flexion (TF), Truncal extension (TE), Shoulder flexion (SF), Shoulder extension (SE), Shoulder abduction (SAB), Shoulder internal rotation (SIR) and Shoulder external rotation (SER), Hip flexion (HF), Hip extension (HE), hip abduction (HAB), hip internal rotation (HIR), hip external rotation (HER), knee extension (KE), Knee Flexion (KF), Ankle Dorsiflexion (ADF) and Ankle Plantar flexion (APF) muscle strengths will be evaluated with hand held dynamometer; Other: Timed Up & Go (TUG); The test will be used by investigators as a simple evaluative test used to measure participants functional mobility.
Control; healthy participants	Other: Demographic information form; aims to collect basic demographic data( Age reported by years , weight and height will be combined to report Body Mass index (BMİ) in kg/m2, Smoking habit reported as smoker or non-smoker , Level of Education reported as illiterate, literate, Primary school, Middle school, High school, University or Post-graduate, Profession type, Significant medical records and Medications.; Other: Muscle Architecture visualized with ultrasound; The three head of Quadratus femoris ( Vastus lateralis, Vastus Medialis and Rectus Femoris), Tibialis Anterior, the two heads of Gastrocnemius ( vastus Lateralis and vastus Medialis) ultrasonography will be performed to evaluate muscle thickness, pennation angle and fascicle length.; Other: Sarcopenia assessed by measuring isometric strengths of different parts of the body; Cervical Flexion (CF), Cervical Extension (CE), Right and Left Cervical Lateral Flexion (CLF R/L), Truncal flexion (TF), Truncal extension (TE), Shoulder flexion (SF), Shoulder extension (SE), Shoulder abduction (SAB), Shoulder internal rotation (SIR) and Shoulder external rotation (SER), Hip flexion (HF), Hip extension (HE), hip abduction (HAB), hip internal rotation (HIR), hip external rotation (HER), knee extension (KE), Knee Flexion (KF), Ankle Dorsiflexion (ADF) and Ankle Plantar flexion (APF) muscle strengths will be evaluated with hand held dynamometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quadriceps Femoris Vastus Lateralis Muscle Thickness	Vastus lateralis ultrasonography will be performed to evaluate muscle thickness.	through study completion, an average of 16 weeks
Quadriceps Femoris Vastus Lateralis Fascicle Length	Vastus lateralis ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA).	through study completion, an average of 16 weeks
Quadriceps Femoris Vastus Medialis Muscle Thickness	Vastus Medialis ultrasonography will be performed to evaluate muscle thickness.	through study completion, an average of 16 weeks
Quadriceps Femoris Vastus Medialis Fascicle Length	Vastus Medialis ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA).	through study completion, an average of 16 weeks
Quadriceps Femoris Rectus Femoris Muscle Thickness	Rectus Femoris ultrasonography will be performed to evaluate muscle thickness.	through study completion, an average of 16 weeks
Quadriceps Femoris Rectus Femoris Fascicle Length	Rectus Femoris ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA).	through study completion, an average of 16 weeks
Tibialis Anterior Muscle Thickness	Tibialis Anterior ultrasonography will be performed to evaluate muscle thickness.	through study completion, an average of 16 weeks
Tibialis Anterior Muscle Fascicle Length	Tibialis Anterior ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA).	through study completion, an average of 16 weeks
Gastrocnemius Muscle Vastus Medialis Muscle Thickness	Gastrocnemius muscle vastus medialis ultrasonography will be performed to evaluate muscle thickness.	through study completion, an average of 16 weeks
Gastrocnemius Muscle Vastus Medialis Fascicle Length	Gastrocnemius muscle vastus medialis ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA).	through study completion, an average of 16 weeks
Gastrocnemius Muscle Vastus Lateralis Muscle Thickness	Gastrocnemius muscle vastus lateralis ultrasonography will be performed to evaluate muscle thickness.	through study completion, an average of 16 weeks
Gastrocnemius Muscle Vastus Lateralis Fascicle Length	Gastrocnemius muscle vastus lateralis ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA).	through study completion, an average of 16 weeks
Cervical Muscle strength	Isometric Cervical Flexion (CF), Isometric Cervical Extension (CE) and Right and Left Isometric Cervical Lateral Flexion (CLF R/L) strengths will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.	through study completion, an average of 16 weeks
Truncal Muscle strength	Isometric Truncal flexion (TF)and Isometric Truncal extension (TE) strengths will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.	through study completion, an average of 16 weeks
Shoulder Muscle strength	Isometric Shoulder flexion (SF), Isometric Shoulder extension (SE), Isometric Shoulder abduction (SAB), Isometric Shoulder internal rotation (SIR) and Isometric Shoulder external rotation (SER) strengths will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.	through study completion, an average of 16 weeks
Hip Muscle strength	Isometric Hip flexion (HF), Isometric Hip extension (HE), Isometric Hip abduction (HAB), Isometric Hip internal rotation (HIR) and Isometric Hip external rotation (HER), strengths will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.	through study completion, an average of 16 weeks
Knee Muscle strength	Isometric Knee extension (KE) and Isometric Knee Flexion (KF) strengths will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.	through study completion, an average of 16 weeks
Ankle Muscle strength	Isometric Ankle Dorsiflexion (ADF) and Isometric Ankle Plantar flexion (APF) strengths will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.	through study completion, an average of 16 weeks
Timed Up & Go (TUG)	The patient sits in the chair with his/her back against the chair back. On the command "go," the patient rises from the chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down. Timing begins at the instruction "go" and stops when the patient is seated and will be reported by seconds. This test aim to determine patients functional state and mobility .	through study completion, an average of 16 weeks

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Investigators: Principal Investigator: Delal Ozturk, Res.Ass, Bezmialem VU

Publications and helpful links

General Publications

• Blazevich AJ, Gill ND, Zhou S. Intra- and intermuscular variation in human quadriceps femoris architecture assessed in vivo. J Anat. 2006 Sep;209(3):289-310. doi: 10.1111/j.1469-7580.2006.00619.x.
• Larsson A, Palstam A, Bjersing J, Lofgren M, Ernberg M, Kosek E, Gerdle B, Mannerkorpi K. Controlled, cross-sectional, multi-center study of physical capacity and associated factors in women with fibromyalgia. BMC Musculoskelet Disord. 2018 Apr 19;19(1):121. doi: 10.1186/s12891-018-2047-1.
• Gyorfi M, Rupp A, Abd-Elsayed A. Fibromyalgia Pathophysiology. Biomedicines. 2022 Nov 29;10(12):3070. doi: 10.3390/biomedicines10123070.
• Blanco I, Beritze N, Arguelles M, Carcaba V, Fernandez F, Janciauskiene S, Oikonomopoulou K, de Serres FJ, Fernandez-Bustillo E, Hollenberg MD. Abnormal overexpression of mastocytes in skin biopsies of fibromyalgia patients. Clin Rheumatol. 2010 Dec;29(12):1403-12. doi: 10.1007/s10067-010-1474-7. Epub 2010 Apr 30.
• Ruggiero L, Manganelli F, Santoro L. Muscle pain syndromes and fibromyalgia: the role of muscle biopsy. Curr Opin Support Palliat Care. 2018 Sep;12(3):382-387. doi: 10.1097/SPC.0000000000000355.
• Chinn S, Caldwell W, Gritsenko K. Fibromyalgia Pathogenesis and Treatment Options Update. Curr Pain Headache Rep. 2016 Apr;20(4):25. doi: 10.1007/s11916-016-0556-x.
• Lund N, Bengtsson A, Thorborg P. Muscle tissue oxygen pressure in primary fibromyalgia. Scand J Rheumatol. 1986;15(2):165-73. doi: 10.3109/03009748609102084.
• Thieme K, Rose U, Pinkpank T, Spies C, Turk DC, Flor H. Psychophysiological responses in patients with fibromyalgia syndrome. J Psychosom Res. 2006 Nov;61(5):671-9. doi: 10.1016/j.jpsychores.2006.07.004.
• Zetterman T, Markkula R, Partanen JV, Miettinen T, Estlander AM, Kalso E. Muscle activity and acute stress in fibromyalgia. BMC Musculoskelet Disord. 2021 Feb 14;22(1):183. doi: 10.1186/s12891-021-04013-1.
• Cigaran-Mendez M, Ubeda-D'Ocasar E, Arias-Buria JL, Fernandez-de-Las-Penas C, Gallego-Sendarrubias GM, Valera-Calero JA. The hand grip force test as a measure of physical function in women with fibromyalgia. Sci Rep. 2022 Mar 1;12(1):3414. doi: 10.1038/s41598-022-07480-1.
• Kuzu O, Aras B. Sonographic measurement of the neck extensor muscle thickness in patients with fibromyalgia. Musculoskelet Sci Pract. 2022 Jun;59:102541. doi: 10.1016/j.msksp.2022.102541. Epub 2022 Feb 26.
• Yurdakul OV, Ince OE, Bagcier F, Kara M, Kultur E, Aydin T. Evaluating the strength of spinal and proximal girdle muscles in patients with axial spondyloarthritis: Correlation with activity, disability, and functionality. Int J Rheum Dis. 2021 May;24(5):701-710. doi: 10.1111/1756-185X.14102. Epub 2021 Mar 22.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: muscle strength; musculoskeletal ultrasound
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Muscle Weakness; Fibromyalgia; Sarcopenia; Myofascial Pain Syndromes
• Other Study ID Numbers: 2023/211

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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