Muscle Architecture and Muscle Strength in Fibromyalgia

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 65 years
• Women only
• No healthy volunteers
• Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Fibromyalgia, Sarcopenia, Muscle Weakness

Being tested

Demographic information form, widespread pain index (WPI), symptom severity scale (SSS), Fibromyalgia Impact Questionnaire (FIQ), Tender Point examination

Keywords

muscle strength, musculoskeletal ultrasound

Medical subject headings

Fibromyalgia, Sarcopenia, Muscle Weakness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Demographic information formOther

  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.

• 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.

• 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 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.

• Tender Point examinationDiagnostic 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.

• Muscle Architecture visualized with ultrasoundOther

  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.

• Sarcopenia assessed by measuring isometric strengths of different parts of the bodyOther

  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

• Timed Up & Go (TUG)Other

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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Quadriceps Femoris Vastus Lateralis Muscle Thickness

   Vastus lateralis ultrasonography will be performed to evaluate muscle thickness.

   Measured: through study completion, an average of 16 weeks

2. Quadriceps Femoris Vastus Lateralis Fascicle Length

   Vastus lateralis ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA).

   Measured: through study completion, an average of 16 weeks

3. Quadriceps Femoris Vastus Medialis Muscle Thickness

   Vastus Medialis ultrasonography will be performed to evaluate muscle thickness.

   Measured: through study completion, an average of 16 weeks

4. Quadriceps Femoris Vastus Medialis Fascicle Length

   Vastus Medialis ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA).

   Measured: through study completion, an average of 16 weeks

5. Quadriceps Femoris Rectus Femoris Muscle Thickness

   Rectus Femoris ultrasonography will be performed to evaluate muscle thickness.

   Measured: through study completion, an average of 16 weeks

6. Quadriceps Femoris Rectus Femoris Fascicle Length

   Rectus Femoris ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA).

   Measured: through study completion, an average of 16 weeks

7. Tibialis Anterior Muscle Thickness

   Tibialis Anterior ultrasonography will be performed to evaluate muscle thickness.

   Measured: through study completion, an average of 16 weeks

8. Tibialis Anterior Muscle Fascicle Length

   Tibialis Anterior ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA).

   Measured: through study completion, an average of 16 weeks

9. Gastrocnemius Muscle Vastus Medialis Muscle Thickness

   Gastrocnemius muscle vastus medialis ultrasonography will be performed to evaluate muscle thickness.

   Measured: through study completion, an average of 16 weeks

10. Gastrocnemius Muscle Vastus Medialis Fascicle Length

    Gastrocnemius muscle vastus medialis ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA).

    Measured: through study completion, an average of 16 weeks

11. Gastrocnemius Muscle Vastus Lateralis Muscle Thickness

    Gastrocnemius muscle vastus lateralis ultrasonography will be performed to evaluate muscle thickness.

    Measured: through study completion, an average of 16 weeks

12. Gastrocnemius Muscle Vastus Lateralis Fascicle Length

    Gastrocnemius muscle vastus lateralis ultrasonography will be performed to evaluate fascicle length through measuring pennation angle (PA).

    Measured: through study completion, an average of 16 weeks

13. 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.

    Measured: through study completion, an average of 16 weeks

14. 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.

    Measured: through study completion, an average of 16 weeks

15. 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.

    Measured: through study completion, an average of 16 weeks

16. 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.

    Measured: through study completion, an average of 16 weeks

17. 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.

    Measured: through study completion, an average of 16 weeks

18. 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.

    Measured: through study completion, an average of 16 weeks

19. 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 .

    Measured: through study completion, an average of 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted22 Apr 2024
2. Study start1 Feb 2024
3. Primary completion30 Apr 2024 (estimated)
4. Study completion30 Jun 2024 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (12)Papers the sponsor has linked to this study.
• Other trials for FibromyalgiaStudies of the same condition, open and under way.
• More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.