AzTrials
AzTrials

FibromyalgiaNCT07649824

Isokinetic Muscle Strength, Torque, Ultrasonographic Muscle Thickness in Fibromyalgia Syndrome: A Case-Control Study

An observational study of Fibromyalgia and Chronic Pain Syndrome, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Fibromyalgia syndrome (FMS) is a chronic disease characterized by widespread body pain and tenderness in specific points, which may be accompanied by sleep disturbances, depression, fatigue, cognitive symptoms such as memory problems and attention deficit, and somatic symptoms such as irritable bowel syndrome and… Read more about this study

Who is it for?
Ages 18 to 55 years, women only
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2024to 25 Jan 2025
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

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 55 years
  • Women only
  • Adult

Study population: The case group consisted of 40 volunteer female patients who presented to the outpatient clinic of the university hospital, agreed to participate in the study, were diagnosed with fibromyalgia syndrome, and met the inclusion criteria. The control group consisted of 40 healthy female volunteers who did not have a diagnosis of fibromyalgia syndrome

Who may be able to join

  • Patient group:
  • female gender
  • 18-55 years old
  • Clinical diagnosis of Fibromyaljia syndrome
  • Control group:
  • female gender
  • 18-55 years old
  • absence of fibromyalgia syndrome diagnosis

Who cannot join

  • Rheumatological disease, crystal arthropathy, septic arthritis
  • Advanced osteoarthritis
  • History of major orthopedic surgery (total knee and hip replacement, etc.)
  • Neurological disease (Parkinson's disease, multiple sclerosis, cerebrovascular event, etc.)
  • Neuromuscular disease (Polyneuropathies, myasthenia gravis)
  • Active malignancy
  • Advanced organ failure/transplantation

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kırşehir Ahi Evran University Faculty of Medicine

    Kırşehir, City Center, 40100

Other trials in Turkey (Türkiye)

About this study

Official title: Isokinetic Knee Flexor and Extensor Strength, Torque, Ultrasonographic Muscle Thickness, Serum Vitamin D Levels, and Sleep Quality in Female Patients With Fibromyalgia Syndrome: A Case-Control Study

Fibromyalgia syndrome (FMS) is a chronic disease characterized by widespread body pain and tenderness in specific points, which may be accompanied by sleep disturbances, depression, fatigue, cognitive symptoms such as memory problems and attention deficit, and somatic symptoms such as irritable bowel syndrome and constipation. The prevalence of FMS has been found to be approximately 2%. It is more frequently diagnosed in women between the ages of thirty and fifty . It is more common in individuals with low socioeconomic status and education level. Its etiology is not fully known. Genetic and some environmental factors are thought to be influential. Central sensitization, autonomic nervous system dysfunction, immune system dysregulation, intestinal microbiota changes, hypothalamic-pituitary-adrenal (HPA) axis and endocrine system disorders are implicated in the pathogenesis (5; 6; 7; 8). FMS diagnostic criteria were first established in 1990 by the American College of Rheumatology (ACR).

According to these criteria, FMS is diagnosed based on the presence of widespread pain and tender points in the body.

Read more

In 2010, the ACR updated the diagnostic criteria by adding the Widespread Pain Index and Symptom Severity Scale. Currently, the 2016 ACR classification criteria are used in the diagnosis of FMS. These criteria consider the presence of pain for at least 3 months, the widespread pain index which assesses the presence of pain in 5 different areas of the body, and the symptom severity scale which assesses fatigue, waking up without rest, and cognitive symptoms. In these criteria, a diagnosis of fibromyalgia can be made independently of other diagnoses; the presence of fibromyalgia does not rule out the presence of other diseases.

The treatment approach for FMS is multidisciplinary. It is considered both non-pharmacological and pharmacological. Non-pharmacological treatment consists of patient education, lifestyle modification, cognitive behavioral therapy, and exercise. Pharmacological treatment includes tricyclic antidepressants, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, and pregabalin. The aim of the study is to evaluate muscle strength, muscle power, muscle thickness, vitamin D levels, and sleep quality in individuals with and without fibromyalgia syndrome, and to identify possible risk factors.

Read the detailed description

In individuals diagnosed with FMS, existing somatic and cognitive symptoms and chronic pain negatively affect the quality of life, sleep quality, work capacity, and productivity of patients. There are studies showing that patients have reduced muscle strength and power compared to the normal population. It is thought that accompanying vitamin D deficiency may deepen fibromyalgia symptoms. In light of this information, considering the importance of enabling individuals diagnosed with FMS in the community to continue to lead an active and pain-free life, the importance of clinical studies on this subject is increasing. The aim of our study is to evaluate muscle strength, muscle power, muscle thickness, vitamin D level, and sleep quality in individuals with and without fibromyalgia syndrome, to calculate possible risk factors, to determine the differences between the two groups, and to contribute to the literature with these data.Muscle tissue assessment is done by measuring functional and structural parameters.

Functionality is assessed by measuring muscle strength and muscle power. For structural measurement, muscle mass and muscle thickness should be considered. To draw a meaningful conclusion, all data must be evaluated together.Computed tomography (CT), magnetic resonance imaging (MRI), bioelectrical impedance analysis (BIA), dual energy X-ray absorptiometry (DEXA), ultrasonography (USG) and anthropometric measurements can be used to assess muscle mass and thickness .Although CT and MRI are gold standards, they are not used in clinical practice.

They are used in scientific research BIA provides information about body structure by taking advantage of the conductivity difference of tissues. It is affected by variables such as nutritional and hydration status, skin temperature, and physical condition. Therefore, it is difficult to establish standards for measurements.

DEXA calculates the difference between the absorption amounts of two different X-rays at low doses from tissues and provides information about body composition. It is frequently used, especially in the diagnosis and follow-up of osteoporosis. Compared to CT, it involves less radiation exposure and is less expensive.

USG is a radiation-free, low-cost, and easily applicable imaging method. Despite the disadvantage of being person-dependent, it is frequently preferred in musculoskeletal system assessment due to its easy accessibility and repeatability. Although there are different modes and frequencies, brightness (B)-mode USG at a frequency of 1-10 MHz is frequently used in tissue thickness measurement.

Using USG, skin, subcutaneous fat tissue, and muscle thicknesses can be evaluated. By looking at the changes in muscle tissue echogenicity, comments can also be made about the structure of muscle tissue .

Anthropometric measurements; It is done using measurements such as body mass index, waist circumference, hip circumference, calf circumference, and arm circumference. The disadvantage is that it does not provide data on muscle strength and power.

Muscle strength is the work produced by a muscle in a certain period of time as a result of voluntary contraction.

It can be measured by isometric, isotonic, and isokinetic methods. Isometric Method: A level of counter-resistance is applied to the muscle that will prevent movement. The high counter-resistance applied ensures maximum loading of the muscle. However, the measurement is only valid for the position in which the measurement is made. Since there is no displacement or movement during the process, no physical work is produced. Isometric measurements are frequently preferred because they are simple and inexpensive. However, since a large part of daily activities involve movement, the data obtained by the isometric method generally does not reflect the muscle capacity in daily activities. Isotonic method: In this method, certain weights are used throughout the range of motion of the joint. The resistance applied to the joint during movement is high at the end of the range of motion and lower at the midpoints. That is, during isotonic measurement, the tension in the muscle can be maximum in only a small part of the range of motion of the joint. For this reason, it is difficult to evaluate the maximum force produced. Isokinetic method: In this method, the angular velocity of the muscle is kept constant, and the counter-resistance that can be applied is kept at its maximum. In this way, the speed of the automatically increasing muscle power is prevented by applying appropriate resistance, and the power to be expended for acceleration is converted into torque. Thus, at a certain angular velocity, the maximum performance that the muscle can produce throughout the range of motion of the joint can be determined by a dynamic method. Thanks to the different angular velocities selected, information about the performance of the muscle is obtained.

Slow angular velocities are preferred in measuring muscle force. Medium and high angular velocities are used to measure muscle energy capacity, endurance, and strength.

Measurements made with an isokinetic dynamometer are considered a valid method for determining muscle strength and power. For this reason, isokinetic dynamometers are frequently preferred to measure muscle strength and power during rehabilitation and exercise. There are points to consider in order to obtain accurate data. One of these is that the individual to be measured should be familiar with the device and understand the operating protocol. For this, light warm-up exercises are recommended before the measurement. These exercises ensure familiarity with the device and reduce the likelihood of muscle injury. If measurements are to be made at different angular velocities, it is recommended that the individual rest for approximately 20 seconds between different angular velocities. The order of the measurement velocities is also important. Measuring low angular velocities before high angular velocities has been found to be more reliable. Individuals being measured may hesitate to exert their maximum effort due to lack of motivation, therefore verbal motivation should be provided during the measurement.

Medical subject headings
Fibromyalgia, Muscular Atrophy

What participants receive

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

Study groups in NCT07649824
Study groupRoleWhat they receive
FibromyalgiaWomen aged 18-55 who have been diagnosed with fibromyalgia syndrome within the last 3 months according to the 2016 ACR Fibromyalgia Syndrome Diagnostic Criteria and the system has a 25 OH vitamin D measurement result.
ControlHealthy women aged 18-55 and the system has a 25 OH vitamin D measurement result.

What is being measured

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

  1. Isokinetic Muscle Strength Assessment

    An isokinetic computerized dynamometer system will be used to measure muscle strength in the dominant knee in both patient and control groups. Strenght (torque) will be measured and recorded in Newton-meters at a speed of 60 degrees per second for 5 repetitions.

    Measured: Baseline

  2. Ultrasound Assessment of Muscle Thickness

    For the ultrasonographic evaluation, a 5-12 MHz linear probe was used. Measurements were taken using standard USG gel. While participants lay supine with their knees fully extended, the distance between the anterior superior iliac spine (SIAS) and the superior aspect of the patella was measured and half of this measurement was marked. The thickness of the quadriceps femoris muscles (M. vastus intermedius and M. rectus femoris) was then measured by holding the USG probe axially without applying pressure.Measurements will be recorded in millimeters.

    Measured: Baseline

  3. Isokinetic Muscle Power Assessment

    An isokinetic computerized dynamometer system will be used to measure muscle power in the dominant knee in both patient and control groups. Power will be measured and recorded in Watts at 180 degrees/second for 15 repetitions.

    Measured: Baseline

Secondary outcomes (3)
  1. Measuring Serum Vitamin D Levels

    . Serum 25(OH)D vitamin levels were measured using the LC-MS/MS (Liquid Chromatography/Mass Spectrometry) method. The reference ranges for the test were: deficiency: <20 ng/ml, insufficiency: 20-30 ng/ml, normal: 30-100 ng/ml, toxicity: >100 ng/ml.

    Measured: Baseline

  2. Assessment of Sleep Quality

    The Pittsburgh Sleep Quality Index (PSQI) was used to assess the sleep quality of all participants. The PSQI is a scale used to evaluate sleep quality and provides a quantitative result. The PSQI consists of 24 questions in total. 19 of these are self-assessment questions, and 5 questions are answered by the individual's spouse or a friend. Data is collected on subjective sleep quality, sleep duration, sleep latency, habitual sleep efficiency, sleep disturbance, sleep medication use, and daytime dysfunction. A score between 0 and 21 is obtained. A higher score indicates poor sleep quality. Those with a total score of 5 or below are considered to have 'good' sleep quality; those with a score above 5 are considered to have 'poor' sleep quality.

    Measured: Baseline

  3. Assessment of Fibromyalgia Syndrome Disease Severity

    Participants in the fibromyalgia syndrome group completed the Fibromyalgia Impact Questionnaire (FIQ) to determine the severity of their fibromyalgia. The total score of the questionnaire ranges from 0 to 100. A higher score indicates that the disease affects the individual more severely

    Measured: Baseline

Timeline

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

  1. First posted16 Jun 2026
  2. Study start1 Apr 2024
  3. Primary completion25 Jan 2025
  4. Study completion25 Jan 2025

Resources

More details

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

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
80 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07649824
Sponsor's protocol ID
SBA 24/516
Status last verified
Jun 2026
First submitted
9 Jun 2026
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: No decision has yet been made regarding IVD.

Publications

  • Rodriguez-Dominguez AJ, Rebollo-Salas M, Chillon-Martinez R, Rosales-Tristancho A, Villa-Del-Pino I, Jimenez-Rejano JJ. The most effective therapeutic exercises for pain intensity in women with fibromyalgia: A systematic review and network meta-analysis. Braz J Phys Ther. 2025 Jul-Aug;29(4):101226. doi: 10.1016/j.bjpt.2025.101226. Epub 2025 May 3.

    PubMed 40319533
  • Mesci E, Dogruoz B, Mesci N, Icagasioglu A. Ultrasonographic evaluation of muscle thickness in female patients with fibromyalgia and its relationship with clinical parameters. North Clin Istanb. 2023 Nov 27;10(6):718-725. doi: 10.14744/nci.2023.04382. eCollection 2023.

    PubMed 38328726

Questions about this trial

What is this clinical trial studying?

An observational study of Fibromyalgia and Chronic Pain Syndrome, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Isokinetic Muscle Strength Assessment (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07649824, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in