Evaluation of the Effects of Exercise-based Rehabilitation in Individuals with Spine Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Change in disability (%)
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 psychologically informed physical therapy are employed in addition to online coaching with a fundamental tenant of core strengthening. Treatments are tracked and modified in a multi-disciplinary format taking all radiographic studies into direct consideration. The goal of this study is to utilize a registry of participants undergoing either in-clinic or online rehabilitation treatment for spine pain at the SpineZone clinical in order to understand the clinical outcomes and costs of different rehabilitation modalities in this patient population.
详细描述
The key objectives for this registry are to 1) identify magnitudes of clinical improvements with this specific specialized rehabilitation program in its various formats (in-clinic vs online), in individuals with or without spine pain for comparison to literature-based standard of care values for other conservative care protocols, 2) to identify average value of this treatment approach based on cost assessment, 3) to identify which patients (based on patient-specific predictors) are most likely to succeed with this specialized program and 4) to identify targets for improvement and optimization of patient care any necessary modifications to the industry's standard for care protocol. The goal of this project is to assess the impact of a standardized program based on core strengthening using technologic monitoring in a multidisciplinary format.
This registry of data will not contain individual identifiers.
The study population is comprised of skeletally mature patients, both male and female, from a wide variety of ethnicities representative of the typical population presenting with spinal conditions, pain, or seeking prevention of future injury. There are no child participants, as they are not candidates for the type of programs under investigation.
All data relating to the patient's physical therapy, diagnosis, co-morbidies, medical history, medications etc., will be used for analysis.
STUDY METHODS:
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 18 years of age
- •under 89 years of age
- •Patients who have been prescribed physical rehabilitation for management of spine pain
排除标准
- •under 18 years of age
- •over 89 years of age
- •Patients who are unable or medically unsafe to participate in physical rehabilitation for management of spine pain as determined by the prescribing physician
结局指标
主要结局
Change in disability (%)
时间窗: 3 months, 6 months, 1 year, and 2 years
difference in Neck Disability Index (for neck pain participants) or Oswestry Disability Index (for Low Back Pain participants), or Scoliosis Research Society Outcomes questionnaire-22 (for Scoliosis participants) between initial evaluation and endpoint
Change in Range of Motion (deg)
时间窗: 3 months, 6 months, 1 year, and 2 years
difference in total spine flexion and extension (in degrees) between initial evaluation and endpoint
Change in pain: Visual Analogue Scale (VAS), 0-100mm
时间窗: 3 months, 6 months, 1 year, and 2 years
difference in VAS (in mm) between initial evaluation and endpoint
Change in quality of life
时间窗: 3 months, 6 months, 1 year, and 2 years
difference in EQ5-D (points) score between initial evaluation and endpoint
Change in strength (lbs*deg)
时间窗: 3 months, 6 months, 1 year, and 2 years
difference in spine extension torque as measured by isokinetic dynamometer between initial evaluation and endpoint
次要结局
- change in spine extensor muscle fatty infiltration (%)(3 months)
- Change in spine extensor muscle cross sectional area (cm2)(3 months)
研究者
Kamshad Raiszadeh, MD
Principal Investigator
SpineZone Medical Fitness, Inc