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

NCT06675708 | Enrolling By Invitation

• 1 other identifier: FIBYSAR2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Creatine; Pain

Outcome Measures

Primary Outcomes (12)

• 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; after finishing the treatment (two months)

• 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; after finishing the treatment (two months)

• 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; after finishing the treatment (two months)

• 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; after finishing the treatment (two months)

• 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; after finishing the treatment (two months)

• 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; after finishing the treatment (two months)

• anthropometric measurements

  anthropometric measurements with the uso of the Tanita

  baseline; after finishing the treatment (two months)

• muscular architectural stockings

  taking architectural muscle averages using an ultrasound scanner

  baseline; after finishing the treatment (two months)

• 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; after finishing the treatment (two months)

• 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; after finishing the treatment (two months)

• 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; after finishing the treatment (two months)

• 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; after finishing the treatment (two months)

Secondary Outcomes (1)

• socio-demographic variables

  baseline

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Dietary Supplement: Creatine

Placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: Dextrose

Interventions

Creatine 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

Experimental group

Dextrose 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.

Placebo group

Eligibility Criteria

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

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
• If they are taking antihypertensive medications

Sponsors & Collaborators

• Camilo Jose Cela University: lead

Study Sites (1)

University Camilo José Cela

Madrid, 28692, Spain

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Creatine; Glucose

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Edurne Úbeda-D'Ocasar, Doctor

  University Camilo José Cela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Edurne Úbeda D'Ocasar

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 5, 2024
• Study Start: February 12, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

ES (1)