Clinical trial NCT06675708: Effectiveness of Creatine on Pain, Fatigue, and Muscle Architectural Variables in Patients Witg Fibromyalgia.
Official title: Study of the Effectiveness of Creatine on Pain, Fatigue, and Muscle Architectural Variables in Patients Witg Fibromyalgia.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Fibromyalgia
Keywords: Creatine
Pain
Lead sponsor: Camilo Jose Cela University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Creatine, a non-protein organic amino acid, is synthesized from arginine, glycine, and methionine. The use of creatine has been shown to be effective in healthy subjects, providing benefits primarily in terms of strength, which has been the main factor studied. In patients with various conditions, including pain, creatine supplementation has demonstrated a reduction in pain and even cognitive improvements.

Due to creatine's general improvement in muscular endurance and fatigue.

Detailed description: Through this study, we aim to analyze whether creatine supplementation can be beneficial in reducing symptoms in patients with Fibromyalgia. Previous studies have demonstrated its benefits, and therefore, we want to evaluate if these benefits can manifest in a shorter time compared to previous studies in 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
* If they are taking antihypertensive medications

Primary outcomes:
measure: Algometer
timeFrame: baseline; after finishing the treatment (two months)
measure: VAS
timeFrame: baseline; after finishing the treatment (two months)
measure: Circometry
timeFrame: baseline; after finishing the treatment (two months)
measure: Dynamometer
timeFrame: baseline; after finishing the treatment (two months)
measure: Chair test
timeFrame: baseline; after finishing the treatment (two months)
measure: Timed up and go
timeFrame: baseline; after finishing the treatment (two months)
measure: anthropometric measurements
timeFrame: baseline; after finishing the treatment (two months)
measure: muscular architectural stockings
timeFrame: baseline; after finishing the treatment (two months)
measure: Pittsburgh
timeFrame: baseline; after finishing the treatment (two months)
measure: FIQ
timeFrame: baseline; after finishing the treatment (two months)
measure: SARC-F
timeFrame: baseline; after finishing the treatment (two months)
measure: HADS
timeFrame: baseline; after finishing the treatment (two months)
Secondary outcomes:
measure: socio-demographic variables
timeFrame: baseline
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: University Camilo José Cela
Study officials:
affiliation: University Camilo José Cela
name: Edurne Úbeda-D'Ocasar, Doctor
role: PRINCIPAL_INVESTIGATOR
References: