Muscle Architecture and Muscle Strength in Fibromyalgia

NCT06378788 | Recruiting

• 1 other identifier: 2023/211
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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?

Conditions

Fibromyalgia; Sarcopenia; Muscle Weakness

Keywords

muscle strength; musculoskeletal ultrasound

Outcome Measures

Primary Outcomes (19)

• 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

Study Arms (2)

Fibromyalgia

Patients meeting the diagnostic criteria of 2016 American College of Rheumatology (ACR) guide for fibromyalgia

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)

Control

healthy participants

Other: Demographic information form; Other: Muscle Architecture visualized with ultrasound; Other: Sarcopenia assessed by measuring isometric strengths of different parts of the body

Interventions

Demographic information form OTHER

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.

Control; Fibromyalgia

widespread pain index (WPI) DIAGNOSTIC_TEST

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.

Fibromyalgia

symptom severity scale (SSS) DIAGNOSTIC_TEST

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.

Fibromyalgia

Fibromyalgia Impact Questionnaire (FIQ) DIAGNOSTIC_TEST

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.

Fibromyalgia

Tender Point examination DIAGNOSTIC_TEST

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.

Fibromyalgia

Muscle Architecture visualized with ultrasound OTHER

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.

Control; Fibromyalgia

Sarcopenia assessed by measuring isometric strengths of different parts of the body OTHER

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

Control; Fibromyalgia

Timed Up & Go (TUG) OTHER

The test will be used by investigators as a simple evaluative test used to measure participants functional mobility.

Fibromyalgia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

RECRUITING

Related Publications (12)

• Gyorfi M, Rupp A, Abd-Elsayed A. Fibromyalgia Pathophysiology. Biomedicines. 2022 Nov 29;10(12):3070. doi: 10.3390/biomedicines10123070.

  PMID: 36551826 BACKGROUND

• 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.

  PMID: 20428906 BACKGROUND

• 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.

  PMID: 29912728 BACKGROUND

• 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.

  PMID: 26922414 BACKGROUND

• 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.

  PMID: 3462905 BACKGROUND

• 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.

  PMID: 17084146 BACKGROUND

• 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.

  PMID: 33583408 BACKGROUND

• 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.

  PMID: 29673356 BACKGROUND

• 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.

  PMID: 35233066 BACKGROUND

• 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.

  PMID: 35240562 BACKGROUND

• 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.

  PMID: 16928199 BACKGROUND

• 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.

  PMID: 33750032 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Sarcopenia; Muscle Weakness

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Delal Ozturk, Res.Ass

  Bezmialem VU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Delal Ozturk, Res.Ass

CONTACT

+902124530453; drdelalozturk@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 22, 2024
• Study Start: February 1, 2024
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)