A Prospective, Randomized Double-Armed Efficacy Evaluation of AposTherapy® for the Treatment of Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster University (WOMAC) Total Score
研究概览
简要总结
A prospective, interventional, randomized, double-arm clinical evaluation study to examine the efficacy of AposTherapy® versus a control group, in the short-term at 6 months and in the long-term at 12 months post-treatment, with the primary efficacy assessment based on improvement in knee pain score and improvement in function in patients following diagnosis of knee osteoarthritis (OA).
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
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from symptomatic unilateral or bilateral knee OA at the medial compartment for at least six months;
- •Fulfilling the ACR clinical criteria;
- •Having radiographically assessed OA of the knee with a Kellgren-Lawrence grade more than or equal to grade 2; and,
- •Having VAS-Pain ≥ 3, on a scale between 0-
- •Patients who have a shoe size between US 4 and US 12
排除标准
- •Patients suffering from acute septic arthritis.
- •Patients who received a corticosteroid injection within 3 months of the study.
- •Patients who received hyaluronic acid (HA) injections within 6 months of the study
- •Patients suffering from avascular necrosis of the knee.
- •Patients with a history of knee buckling or recent knee injury.
- •Patients who have had a joint replacement or other major surgery to the knee, hip or ankle (ipsilateral or contralateral side).
- •Patients suffering from neuropathic arthropathy.
- •Patients with an increased tendency to fall.
- •Patients exhibiting a lack of physical or mental ability to perform or comply with the study procedure.
- •Patients with a history of pathological osteoporotic fracture.
- •Patients suffering from symptomatic degenerative arthritis in lower limb joints other than the knees.
- •Patients with referred pain in the knees from primary back or hip joint pain.
- •Patients with neurological deficits to the lower extremity (ex. foot drop)
- •Patients whose shoe size is less than US 4 and greater than US 12
- •Patients who have had arthroscopy within 6 months of the study
- •Patients with inflammatory arthropathy
结局指标
主要结局
Western Ontario and McMaster University (WOMAC) Total Score
时间窗: screening, 3 months, 6 months, 9 months, and 12 months
WOMAC evaluates the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. In this study, WOMAC scores were recomputed as the sum within sub-scales (pain score is the sum of questions 1-5; stiffness is the sum of questions 6-7; functional score is the sum of questions 8-24). The total score is reported as the sum of the pain, stiffness, and functional sub-scores for all participants. The total score range is 0-1292. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
次要结局
- Short-Form 36 (SF-36) Total Score(screening, 3 months, 6 months, 9 months, and 12 months)
- Visual Analog Score (VAS) Score(12 Months)