Muscle Architecture and Muscle Strength in Fibromyalgia
NCT06378788 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30
Last updated 2024-04-25
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
Interventions
- 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.
Sponsors & Collaborators
-
Bezmialem Vakif University
lead OTHER
Principal Investigators
-
Delal Ozturk, Res.Ass · Bezmialem VU
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-01
- Primary Completion
- 2024-04-30
- Completion
- 2024-06-30
Countries
- Turkey (Türkiye)
Study Locations
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