Study of the Effectiveness of Creatine on Pain, Fatigue, and Muscle Architectural Variables in Patients Witg Fibromyalgia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Algometer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with FM
- •aged between 18 and 75 years
- •agree to participate and sign the informed consent
排除标准
- •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
研究组 & 干预措施
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
干预措施: Dextrose (Dietary Supplement)
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.
干预措施: Creatine (Dietary Supplement)
结局指标
主要结局
Algometer
时间窗: 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.
VAS
时间窗: 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
Circometry
时间窗: 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.
Dynamometer
时间窗: 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
Chair test
时间窗: 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.
Timed up and go
时间窗: 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.
anthropometric measurements
时间窗: baseline; after finishing the treatment (two months)
anthropometric measurements with the uso of the Tanita
muscular architectural stockings
时间窗: baseline; after finishing the treatment (two months)
taking architectural muscle averages using an ultrasound scanner
FIQ
时间窗: 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.
SARC-F
时间窗: 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.
Pittsburgh
时间窗: 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.
HADS
时间窗: 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.
次要结局
- socio-demographic variables(baseline)
研究者
Edurne Úbeda D'Ocasar
Doctor Edurne Úbeda D'Ocasar
Camilo Jose Cela University