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NCT Number: NCT06253273

Functional Assessment of the Patient With Fibromyalgia and Its Relation to Health: Fibromyalgia and Sarcopenia

Fibromyalgia is a chronic syndrome that causes fatigue, sleep disorders and generalized chronic pain in different parts of the body. This pathology is more prevalent in women and is generally not attributed to any specific cause.

This observational study aims to describe some important and health-related factors in patients with fibromyalgia.

Participants will have to fill out questionnaires related to sleep, anxiety, impact of the disease and sarcopenia index, and will then take tests related to grip strength for the upper limbs and dynamometry in the lower limbs. We will also employ the use of ultrasound to evaluate architectural measurements. Last but not least, we cannot forget the pain measurements that are so necessary in this study population.

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Key information

Conditions

Fibromyalgia Atrophy Muscular Atrophy Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rheumatic Diseases Sarcopenia Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Camilo José Cela

Madrid, 28692, Spain

About this study

Through the present research study we intend to analyze not only the health status of our sample but also to correlate the parameters analyzed with factors related to sarcopenia.

Through the data collection that will be carried out we can analyze variables as essential as pain, anxiety and depression, impact of the disease, agility, strength, anthropometric measurements, sleep and muscular architectural measurements by means of ultrasound in which we can analyze the fatty infiltration of structures such as the vastus lateralis, rectus anterior and vastus medius that allow us to obtain data that can define the characteristics of patients with fibromyalgia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with FM
  • aged between 18 and 75 years
  • agree to participate and sign the informed consent.

Exclusion criteria

  • who do not have recent surgeries
  • patients with reduced mobility
  • adequate level of comprehension to be able to answer the questionnaires that will be provided in the study.

Treatment and study plan

Primary outcomes

  1. Algometer

    Time frame: baseline

    Algometer points: Using an algometer, the pain threshold at each tender point is measured in kg/cm. The higher the value obtained, the less pain the subject has.

  2. VAS

    Time frame: baseline

    Visual Analogic Scale: this self-referenced scale ranges from 0 to 10 where 0 is no pain at all and 10 indicates the worst possible pain endured. The higher the score, the greater the pain

  3. Circometry

    Time frame: baseline

    Contour measurements: The contour of the segment selected for the study will be measured using a tape measure. It is measured in centimeters. the greater the number of centimeters, the greater the diameter and therefore the worse the condition or greater the liquid retention of the subject.

  4. Dynamometer

    Time frame: baseline

    upper limb grip strength: this measuring tool measures upper limb grip strength. the higher the value, the better the subject's state of strength

  5. Iso-pull

    Time frame: baseline

    lower limb strength: this measuring tool measures the strength of lower limbs. the higher the value, the better the subject's state of strength.

  6. Chair test

    Time frame: baseline

    number of squats for 30 seconds: this test consists of seeing how many squats can be done in the test time. The greater the number of squats, the better the subject will be.

  7. Timed up and go

    Time frame: baseline

    balance test: The Timed Up and Go Test is an easy-to-use test to assess the risk of falls.The shorter the test time, the lower the risk of falling.

  8. anthropometric measurements

    Time frame: baseline

    anthropometric measurements with the uso of the Tanita

  9. muscular architectural stockings

    Time frame: baseline

    taking architectural muscle averages using an ultrasound scanner

  10. Pittsburgh

    Time frame: baseline

    sleep quality questionnaire: This test has values from 0 to 21 points maximum. It is interpreted that the higher the score, the worse the quality of sleep.

  11. FIQ

    Time frame: baseline

    fibromyalgia impact questionnaire: The total FIQ score is between 0-100 as each of the items has a score of 0-10 once adapted. Thus, 0 represents the highest functional capacity and quality of life and 100 the worst state.

  12. SARC-F

    Time frame: baseline

    questionnaire to measure sarcopenia risk: The SARC-F is a quick and easy instrument for detecting the risk of sarcopenia, which asks the degree of difficulty an older adult has in performing 4 functional activities. A score greater than 4 indicates risk of sarcopenia.

  13. HADS

    Time frame: baseline

    to evaluate emotional distress in patients with different chronic conditions, assessing cognitive and behavioral symptoms of anxiety and depression. The HADS is composed of two subscales: Depression and Anxiety, each with seven items. The score of each subscale can vary between 0 and 21, since each item presents four response options, ranging from absence/minimal presence = 0, to maximum presence = 3.

Secondary outcomes

  1. socio-demographic variables

    Time frame: baseline

    socio-demographic variables (age, weight, height, medication intake, marital status, employment status, etc.

Sponsors and collaborators

Lead sponsor

Camilo Jose Cela University

Other

Registry information

Acronym: FIBYSAR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2024
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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