Patient With Cervical Radiculopathy - Complete Assessment and Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Neck Disability Index
研究概览
简要总结
The investigators perform a prospective controlled study and analyse the effects of a rehabilitation program, including oral anti-inflammatory drugs, nutraceutical - ProHumano+ SpineDinamic (PHSD), physical therapy and kinetic measures on reduction of the severity of radicular pain, and improvement of the quality of life in participants with cervical radiculopathy (CR) over a relatively short period of treatment (three months).
The major tasks in the assessment and management of CR are to exclude signs and/or symptoms of possible serious underlying pathology, to focus on an active approach to promote the natural recovery and to prevent chronicity through early tailored rehabilitation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients older than 50 years of age;
- •lasting more than 3 months and diagnosed with CR confirmed by MRI in the last 6 months;
- •absence of other significant and disability upper limb osteoarthritis;
- •patients with stable cardiovascular and respiratory function, without unstable medical conditions;
- •compliance with physical exercise during the healthcare program.
排除标准
- •pregnancy or breastfeeding;
- •need for surgical treatment;
- •intolerance to any component of the nutraceutical product;
- •malignancy;
- •modified laboratory test (ALT, AST, or Urea >2x% reference range, Creatinine >3x% reference range).
结局指标
主要结局
Neck Disability Index
时间窗: 3 months
Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Score: /50 Transform to percentage score x 100 = %points Scoring: For each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5. If all ten sections are completed the score is calculated Minimum Detectable Change (90% confidence): 5 points or 10 %points
Visual Analogue Scale For Pain
时间窗: 3 months
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. Values close to 100 show a maximum value of pain, and 0 the absence of pain.
次要结局
- Improving quality of life- Katz Index of Independence in Activities of Daily Living(3 months)
研究者
Diana Kamal
PhD
Filantropia Hospital