Clinical trial NCT06253273: Functional Assessment of the Patient With Fibromyalgia and Its Relation to Health: Fibromyalgia and Sarcopenia
Official title: Functional Assessment of the Patient With Fibromyalgia and Its Relation to Health: Fibromyalgia and Sarcopenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Sarcopenia
Lead sponsor: Camilo Jose Cela University
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with fibromyalgia belonging to the Asocación Afinsyfacro de Móstoles. All men and women of the Association who meet the inclusion and exclusion criteria may participate.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Algometer
timeFrame: baseline
measure: VAS
timeFrame: baseline
measure: Circometry
timeFrame: baseline
measure: Dynamometer
timeFrame: baseline
measure: Iso-pull
timeFrame: baseline
measure: Chair test
timeFrame: baseline
measure: Timed up and go
timeFrame: baseline
measure: anthropometric measurements
timeFrame: baseline
measure: muscular architectural stockings
timeFrame: baseline
measure: Pittsburgh
timeFrame: baseline
measure: FIQ
timeFrame: baseline
measure: SARC-F
timeFrame: baseline
measure: HADS
timeFrame: baseline
Secondary outcomes:
measure: socio-demographic variables
timeFrame: baseline
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: University Camilo José Cela
Study officials:
affiliation: Associate Professor
name: Edurne Úbeda D'ocasar
role: PRINCIPAL_INVESTIGATOR
References: