ISRCTN12631735进行中（未招募）未知
A randomized, double-blind placebo-controlled study to assess the effect of choline-stabilized orthosilicic acid on lateral epicondylitis
Bio Minerals NV0 个研究点目标入组 148 人开始时间: 2020年9月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 148
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Provision of written informed consent
- •2. Males, pre-menopausal females, peri- or post-menopausal females currently taking hormone replacement therapy between the ages of 18 and 70 years old
- •3. Females must use an approved form of birth control
- •4. Painful, chronic tendinopathy present in lateral elbow in one arm. The baseline elbow is > 40 on a scale of 100 mm (VAS: 0 representing no pain and 100 worst imaginable pain) during elbow extension and resisted wrist extension (Cozen's test)
- •5. The epicondylitis symptoms lasting at least 12 weeks or longer
- •6. A history of at least two periods of elbow pain lasting >10 days
- •7. BMI between 18.5 and 35 kg/m²
- •8. Participant must continue his/her normal physical activities during the study i.e. there should be no change in physical activity after the screening visit
排除标准
- •1. Unable to understand the study procedures and/or not wishing to participate in one of the subsequent therapeutic intervention protocols
- •2. Poor general health interfering with compliance or assessment
- •3. Unlikely to co-operate fully in the study
- •4.. Participating in another clinical trial in the last 90 days
- •5. Pregnancy or breastfeeding
- •6. Radiological examinations show abnormalities such as arthritis and inflammatory arthropathy of the elbow joint in the target arm
- •7. Participants with a history of trauma, ligament damage, fracture, tumor or surgery of the elbow joint in the target arm
- •8. Proven and current symptomatic peripheral nerve entrapment syndrome
- •9. Proven and current symptomatic cervical facet arthrosis: C5-C6/C6-C7
- •10. Proven and current symptomatic radiculopathy
- •11. Fibromyalgia, chronic fatigue syndrome
- •12. New physical activity i.e. physical activity which was not present prior to the screening visit
- •13. Recent or current alcohol abuse
- •14. Participants with documented, active infection diseases such as HIV or hepatitis B/C
- •15. Clinically significant medical abnormalities which would make the subject unsuitable for the study, as judged by the investigator, such as mental disorders
- •16. Participant has documented renal failure, history of stroke, myocardial infarct or cancer
- •17. Concomitant and previous medication
- •17.1. Less than 6 months between the local treatment of epicondylitis with platelet-rich plasma (PRP), autologous conditioned plasma (ACP) or autologous whole blood (AWB) injections and inclusions in the study
- •17.2. Less than 3 months between the local treatment of epicondylitis with shockwaves or steroid injections and inclusion in the study
- •17.3. Less than 6 weeks between the local treatment of epicondylitis with botulinum toxin, glycosaminoglycan polysulfate (hyaluronic acid) or dextrose injections and inclusion in the study
- •17.4. Less than 15 days between the treatment and inclusion in the study: systemic or topical use of NSAIDs and analgesics, different from paracetamol; systemic opoids and corticosteroids; treatment for epicondylitis with acupuncture or physiotherapy
- •17.5. Less than 3 months between supplementation with food supplements containing horsetail extract, bamboo extract, silicic acid or silanol derivatives and inclusion in the study
研究者
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