Effectiveness of Creatine on Pain, Fatigue, and Muscle Architectural Variables in Patients Witg Fibromyalgia.

NCT ID: NCT06675708

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-12

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental group

The creatine experimental group will receive 20g of creatine for 5 days, divided into 4 equal doses, followed by 5g/day as a single dose for the duration of the trial.

Group Type EXPERIMENTAL

Creatine

Intervention Type DIETARY_SUPPLEMENT

From the total sample obtained after recruitment, randomization will be performed using the SPSS statistical program, creating two groups. One experimental group will receive creatine supplementation, and the other group will receive a placebo through dextrose administration. In both cases, the doses will be administered in the same manner to both groups

Placebo group

The placebo group will receive 20g of dextrose for 5 days, divided into 4 equal doses, followed by 5g/day as a single dose for the duration of the trial

Group Type PLACEBO_COMPARATOR

Dextrose

Intervention Type DIETARY_SUPPLEMENT

From the total sample obtained after recruitment, randomization will be performed using the SPSS statistical program, creating two groups. Dextrose group will be administered in the same manner as creatine to the experimental group. The doses will be prepared in the same way for both groups.

Interventions

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Creatine

From the total sample obtained after recruitment, randomization will be performed using the SPSS statistical program, creating two groups. One experimental group will receive creatine supplementation, and the other group will receive a placebo through dextrose administration. In both cases, the doses will be administered in the same manner to both groups

Intervention Type DIETARY_SUPPLEMENT

Dextrose

From the total sample obtained after recruitment, randomization will be performed using the SPSS statistical program, creating two groups. Dextrose group will be administered in the same manner as creatine to the experimental group. The doses will be prepared in the same way for both groups.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Camilo Jose Cela University

OTHER

Sponsor Role lead

Responsible Party

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Edurne Úbeda D'Ocasar

Doctor Edurne Úbeda D'Ocasar

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edurne Úbeda-D'Ocasar, Doctor

Role: PRINCIPAL_INVESTIGATOR

University Camilo José Cela

Locations

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University Camilo José Cela

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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FIBYSAR2

Identifier Type: -

Identifier Source: org_study_id

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