Fibromyalgia, Sarcopenia, Muscle Weakness
Conditions
Keywords
muscle strength, musculoskeletal ultrasound
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.
Interventions
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_TESTwidespread 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_TESTsymptom 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_TESTFibromyalgia 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_TESTTender 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.
OTHERMuscle 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.
OTHERSarcopenia 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
OTHERTimed Up & Go (TUG)
The test will be used by investigators as a simple evaluative test used to measure participants functional mobility.
Sponsors
Bezmialem Vakif University
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quadriceps Femoris Vastus Lateralis Muscle Thickness | through study completion, an average of 16 weeks | Vastus lateralis ultrasonography will be performed to evaluate muscle thickness. |
| Quadriceps Femoris Vastus Lateralis Fascicle Length | through study completion, an average of 16 weeks | Vastus lateralis ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA). |
| Quadriceps Femoris Vastus Medialis Muscle Thickness | through study completion, an average of 16 weeks | Vastus Medialis ultrasonography will be performed to evaluate muscle thickness. |
| Quadriceps Femoris Vastus Medialis Fascicle Length | through study completion, an average of 16 weeks | Vastus Medialis ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA). |
| Quadriceps Femoris Rectus Femoris Muscle Thickness | through study completion, an average of 16 weeks | Rectus Femoris ultrasonography will be performed to evaluate muscle thickness. |
| Quadriceps Femoris Rectus Femoris Fascicle Length | through study completion, an average of 16 weeks | Rectus Femoris ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA). |
| Tibialis Anterior Muscle Thickness | through study completion, an average of 16 weeks | Tibialis Anterior ultrasonography will be performed to evaluate muscle thickness. |
| Tibialis Anterior Muscle Fascicle Length | through study completion, an average of 16 weeks | Tibialis Anterior ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA). |
| Gastrocnemius Muscle Vastus Medialis Muscle Thickness | through study completion, an average of 16 weeks | Gastrocnemius muscle vastus medialis ultrasonography will be performed to evaluate muscle thickness. |
| Gastrocnemius Muscle Vastus Medialis Fascicle Length | through study completion, an average of 16 weeks | Gastrocnemius muscle vastus medialis ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA). |
| Gastrocnemius Muscle Vastus Lateralis Muscle Thickness | through study completion, an average of 16 weeks | Gastrocnemius muscle vastus lateralis ultrasonography will be performed to evaluate muscle thickness. |
| Gastrocnemius Muscle Vastus Lateralis Fascicle Length | through study completion, an average of 16 weeks | Gastrocnemius muscle vastus lateralis ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA). |
| Cervical Muscle strength | through study completion, an average of 16 weeks | 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. |
| Truncal Muscle strength | through study completion, an average of 16 weeks | 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. |
| Shoulder Muscle strength | through study completion, an average of 16 weeks | 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. |
| Hip Muscle strength | through study completion, an average of 16 weeks | 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. |
| Knee Muscle strength | through study completion, an average of 16 weeks | 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. |
| Ankle Muscle strength | through study completion, an average of 16 weeks | 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. |
| Timed Up & Go (TUG) | through study completion, an average of 16 weeks | 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 . |
Countries
Turkey (Türkiye)
Contacts
Primary ContactDelal Ozturk, Res.Ass
Outcome results
None listed