Pilot Study of a Cohort of Patients Affected by Fibromyalgia for Symptomatic Improvement by Means of a Food Supplement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Symptomatic change of fibromyalgia through the Fibromyalgia Impact Questionnaire (s-FIQ), after taking the FibrofixPlus® food supplement, for 8 weeks.
研究概览
简要总结
Fibromyalgia is a syndrome (set of symptoms) of unknown etiology and characterized by diffuse musculoskeletal pain and chronic fatigue. In addition, other symptoms such as cognitive alterations, sleep rhythm disturbances, psychiatric syndromes such as anxiety, depression, etc. Other very characteristic symptoms are hyperalgesia (very low pain threshold) and allodynia (amplified response to painful stimuli).
The treatment of fibromyalgia is symptomatic and the drugs only serve to reduce symptoms in some patients, in addition to the fact that these available treatments (antidepressants, pain signal modulators, rescue analgesics, etc.) have many side effects.
The food supplement which is the object of this study, FibrofixPlus®, is made up of a combination of natural substances.
This is the reason why this observational study aims to improve symptoms caused by fibromyalgia in patients treated with FibrofixPlus®.
详细描述
Patients who meet the fibromyalgia criteria according to the definition of the American College of Rheumatology (ACR) in 1990 and 2010, with a minimum score of 4 on the Visual Analogue Scale (VAS) of Fatigue and Pain and without any treatment (anxiolytics, neuroleptics, antidepressants and/or narcotic analgesics) in a minimum of 4 weeks prior to the beginning of the study, with some exceptions, and who do not meet any of the exclusion criteria will be invited to participate in the study.
There are three study visits which are distributed throughout 8 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥ 18 years.
- •Meet the fibromyalgia criteria according to the definition of the American College of Rheumatology of 1990 and
- •Minimum score of 4 on the Visual Analogue Scale (VAS) for Fatigue and Pain.
- •Period prior to the start of the study of a minimum of 4 weeks without treatment with anxiolytics, neuroleptics, antidepressants and/or narcotic analgesics. The use of paracetamol up to 2 g/day is allowed, and tramadol 100 mg/8h maximum.
排除标准
- •Current diagnosis of a psychiatric disorder other than major depressive disorder.
- •Pain caused by a traumatic or structural injury.
- •Chronic inflammatory diseases.
- •Autoimmune disease.
- •Use of medications that may interfere with the assessment of pain improvement, including analgesics (with the exception stated in the inclusion criteria), antidepressants, anticonvulsants, or other medication taken to combat fibromyalgia, fatigue or pain.
- •Rehabilitation with therapeutic intent.
- •Intent to apply or current disability application process.
- •Natural therapies (homeotherapy, acupuncture, food, etc.) to improve fibromyalgia.
- •Hypersensitivity to the active principles or to any of the excipients of the products included in the study.
- •Pregnancy.
- •Breastfeeding.
结局指标
主要结局
Symptomatic change of fibromyalgia through the Fibromyalgia Impact Questionnaire (s-FIQ), after taking the FibrofixPlus® food supplement, for 8 weeks.
时间窗: From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).
To assess the magnitude of the symptomatic improvement by measuring the results to questions of the Fibromyalgia Impact Questionnaire (s-FIQ). This questionnaire scores from 0 to 100, being 0 the best quality of life and functional capacity, and 100 is the worst result.
次要结局
- Change of pain symptom through the Symptom Severity Score (SS Score).(From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).)
- Change of pain symptom through the Widespread Pain Index (WPI).(From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).)
- Change of the sleep quality through the Pittsburgh Sleep Quality Index (PSQI).(From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).)
- Rate of safety episodes.(Visit 1 to Visit 2, up to 4 weeks.)
- Change of the sleep quality through the Symptom Severity Score (SS Score).(From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).)
- Change on the quality of life through the questionnaire Short Form-36.(At Visit 0 and at Visit 2, or 8 weeks after Visit 0.)
- Change of fatigue symptom through the Visual Analogue Scale (VAS).(From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).)
- Change of fatigue symptom through the Symptom Severity Score (SS Score).(From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).)
- Change on the functional impairment through the questionnaire Clinical Global Impressions (CGI).(From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).)
- Change on the quality of life through the questionnaire Clinical Global Impressions (CGI).(From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).)
- Change on the quality of life through the questionnaire Hospital Anxiety and Depression Scale (HADS).(At Visit 0 and at Visit 2, or 8 weeks after Visit 0.)
- Change of pain symptom through the Visual Analogue Scale (VAS).(From Visit 0, and at each visit (Visit 1 or 4 weeks after Visit 0; and Visit 2 or 8 weeks after Visit 0).)
- Change on the functional impairment through the questionnaire Short Form-36 Questionnaire (SF-36).(At Visit 0 and at Visit 2, or 8 weeks after Visit 0.)