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

NCT06253273 | Completed

• 1 other identifier: CamiloJcUFYS
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Sarcopenia

Outcome Measures

Primary Outcomes (13)

• Algometer

  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.

  baseline

• VAS

  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

  baseline

• Circometry

  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.

  baseline

• Dynamometer

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

  baseline

• Iso-pull

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

  baseline

• Chair test

  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.

  baseline

• Timed up and go

  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.

  baseline

• anthropometric measurements

  anthropometric measurements with the uso of the Tanita

  baseline

• muscular architectural stockings

  taking architectural muscle averages using an ultrasound scanner

  baseline

• Pittsburgh

  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.

  baseline

• FIQ

  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.

  baseline

• SARC-F

  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.

  baseline

• HADS

  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.

  baseline

Secondary Outcomes (1)

• socio-demographic variables

  baseline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Camilo Jose Cela University: lead

Study Sites (1)

University Camilo José Cela

Madrid, 28692, Spain

Location

MeSH Terms

Conditions

Fibromyalgia; Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

• Edurne Úbeda D'ocasar

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: October 31, 2024
• Primary Completion: April 3, 2025
• Study Completion: May 3, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

ES (1)