Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06675708

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Camilo José Cela

Madrid, 28692, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Algometer

    Time frame: baseline; after finishing the treatment (two months)

    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.

  2. VAS

    Time frame: baseline; after finishing the treatment (two months)

    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

  3. Circometry

    Time frame: baseline; after finishing the treatment (two months)

    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.

  4. Dynamometer

    Time frame: baseline; after finishing the treatment (two months)

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

  5. Chair test

    Time frame: baseline; after finishing the treatment (two months)

    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.

  6. Timed up and go

    Time frame: baseline; after finishing the treatment (two months)

    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.

  7. anthropometric measurements

    Time frame: baseline; after finishing the treatment (two months)

    anthropometric measurements with the uso of the Tanita

  8. muscular architectural stockings

    Time frame: baseline; after finishing the treatment (two months)

    taking architectural muscle averages using an ultrasound scanner

  9. Pittsburgh

    Time frame: baseline; after finishing the treatment (two months)

    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.

  10. FIQ

    Time frame: baseline; after finishing the treatment (two months)

    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.

  11. SARC-F

    Time frame: baseline; after finishing the treatment (two months)

    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.

  12. HADS

    Time frame: baseline; after finishing the treatment (two months)

    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.

Secondary outcomes

  1. socio-demographic variables

    Time frame: baseline

    socio-demographic variables (age, weight, height, medication intake, marital status, employment status, etc.

Sponsors and collaborators

Lead sponsor

Camilo Jose Cela University

Other

Registry information

Official study title

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

Acronym: SECPFMAPFM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 5, 2024
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.