Development of Sanomechanics® Rehabilitative Technology for Normalizing Contact Pressure in Painful Joints by Activating the Newly Discovered Floating Skeleton System.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- The WOMAC self-reported function score
研究概览
简要总结
Rehabilitative Sanomechanics Method (RSM) of exercise designed to restore normal subperiosteal transmission of in-joint pressures and normalizing contact pressures on cartilages, will reduce pain in the affected joints and improve locomotor function.
详细描述
Specific Aim 1: In a clinical trial with subjects reporting arthritic knee pain, demonstrate that the Sanomechanics method of exercise, focused on restoring normal subperiosteal transmission of in-joint pressures, will reduce pain. Using the validated WOMAC questionnaire as a Patient- Reported Outcome (PRO) tool, the associated primary endpoint is that 80% of patients will report a reduction in pain at the end of the 3-month study based on the 5-point categorical WOMAC pain scale.
Specific Aim 2: To demonstrate that Sanomechanics will improve normal synergy in gait by mitigating compensatory gait strategy, which one develops to avoid unbearable pain in the joint. The associated co-primary endpoint is that 80% of patients will experience an increase in stance knee flexion angle. The secondary endpoint is that the 80% of patients will report a lowered WOMAC function score based on 5-point categorical WOMAC scale (lower score corresponds to better self-reported function) after the three-month study.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral knee pain with WOMAC score 6-
- •Knee pain, aching or stiffness on most days in the past month and definite radiographic osteoarthritis in the index knee.
- •Morning stiffness >30 min.
- •Age: 40-75 years of age.
- •More pain in the morning compared to evening.
- •English speakers.
- •Have daily access to an email address and a computer with Internet
- •Allowed to be on prescription or non-prescription medicine for pain during the course of the study.
排除标准
- •Inability to communicate in English
- •Lower limb injury, surgery, or intra-articular injection in the past 6-months
- •Current pregnancy
- •Have a pacemaker or other internal medical device
- •Cancer not in remission
- •History of stroke affecting lower limb
- •Major trauma
- •Gross knee instability on exam
- •Lumbar radiculopathy affecting symptomatic limb
- •KL radiographic score 4
- •Morphological indications (bone-on-bone contact) for joint replacement
结局指标
主要结局
The WOMAC self-reported function score
时间窗: 90 days
80% of patients will report a lowered WOMAC function score based on 5-point categorical WOMAC scale (lower score corresponds to better self-reported function) after the three-month study.
The WOMAC self-reported pain score .
时间窗: 90 days
80% of patients will report a reduction in pain at the end of the 3-month study based on the 5-point categorical WOMAC pain scale.
次要结局
未报告次要终点