The Influence of a Protein Nutrition Beverage on Exercise-based Rehabilitation Outcomes in Individuals with Spine Pain.
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Muscle size
研究概览
简要总结
SpineZone is an innovative physical therapy program with its focus on treatment of cervical, thoracic, and lumbar conditions through the use of a multi-disciplinary, technology enabled platform. Standard physical therapy modalities including exercise-based rehabilitation as well as patient education on a healthy lifestyle (sleep, nutrition, posture) are employed as part of the standard treatment. As nutrition is a key element in modulating muscle growth and function in response to exercise, providing patients with appropriate access to nutritional supplements that meet the metabolic demands of our exercise program are potentially important to our clinical outcomes.
详细描述
Low back pain manifests itself clinically with pain, loss of strength, difficulty with normal posture, and decreased range of motion. In as many as 60-85% cases, LBP will become a chronic condition, requiring long term care, and even surgery.
Conservative therapy is typically administered until it's no longer a viable option, after which surgical options are considered. Conservative therapy includes physical therapy, medication, steroid injections etc. Physical therapy and exercises are especially central to conservative therapy. Numerous exercise and therapy protocols have been designed with the goal to improve low back muscle strength, thereby alleviating symptoms, and potentially underlying cause of the pathology.
As nutrition is a key element in modulating muscle growth and function in response to exercise, providing patients with appropriate access to nutritional supplements that meet the metabolic demands of our exercise program are potentially important to our clinical outcomes.
The project specifically aims to assess the effect of ensuring adequate nutritional availability of protein, as protein shake, as part of their standard care for treatment of low back pain typically 4-12 weeks duration. In this experiment, we will compare muscle structure and health and correlate improvements with patient-specific characteristics such as demographics, medical history, medication usage, treatment expectations, and symptom severity. Subsequently, this information will enable us to gain valuable insight into physiological response of pathological tissue, and potentially, develop optimal exercise plans to maximally benefit these patients.
AIMS OF THE STUDY
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Seeking treatment for spinal conditions, pain or for the prevention of future injury
- •Ability to consume protein shake and follow storage, timing and preparation instructions
- •Indicated by a qualified health care provider to safely participate in an exercise-based rehabilitation program
- •Ability to read and comprehend the English language
排除标准
- •Certain medical conditions, diagnosis, physical or psychological or physical exam finding that precludes participation, medications, or contraindications for protein supplement
- •Individuals who are determined by their health care provider to be contraindicated for participation in an exercise-based rehabilitation program
- •Individuals with food allergies to animal based products, nuts, and/or eggs
- •Individuals with consumption preferences omitting non-vegan or vegetarian products
- •Taking protein supplements already
- •History of severe liver disorder
- •History of Kidney disorder
- •History of diabetes
- •History of Gastrointestinal malabsorption
- •History of Parathyroid gland disorders
- •Pregnant, postpartum up to six months, lactating, or intention to become pregnant
研究组 & 干预措施
Protein Intervention Group
Patients who receive the protein nutritional supplement as part of their prescribed exercise-based rehabilitation program.
干预措施: Protein supplement (Dietary Supplement)
Control Group
Patients who receive the prescribed exercise-based rehabilitation program, without protein supplement.
结局指标
主要结局
Muscle size
时间窗: 3 months, 6 months, 1 year, 2 years
Change in spine extensor muscle cross sectional area (cm2)
次要结局
- Change in strength (lbs*deg)(3 months, 6 months, 1 year, 2 years)
- Change in disability(3 months, 6 months, 1 year, 2 years)
- Patient Goal Achievement(3 months, 6 months)
- Symptom inference - change in pain. Visual Analogue Scale (VAS), 0-100mm(3 months, 6 months, 1 year, 2 years)
研究者
Kamshad Raiszadeh, MD
Chairman, Cheif Medical Officer
SpineZone Medical Fitness, Inc