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临床试验/NCT02067208
NCT02067208已完成不适用

Reduced Knee Joint Loading With Lateral and Medial Wedge Insoles for Management of Knee Osteoarthritis: a Randomized Controlled Trial

University of Calgary2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
KOOS pain score

研究概览

简要总结

Knee osteoarthritis (OA) is commonly treated using laterally wedged insoles. Although these insoles typically reduce knee abduction moments (KAM) - a variable associated with knee osteoarthritis - and thus are believed to be beneficial for OA management, recent research has indicated that in some cases lateral wedge insoles actually increase knee joint loads. In such cases, a medial wedge may be more appropriate.

The purpose of this study is to evaluate the influence of reduced KAMs on pain over 3-months for patients with knee OA. It is hypothesized that pain reduction will be directly related to KAM reduction.

Forty-six participants with knee OA will be recruited to participate. Each will undergo biomechanical gait analysis to determine the wedge type that most greatly reduces knee adduction moments. In addition, each participant will undergo a Dual Energy X-Ray Absorptiometry (DXA) scan to quantify adiposity. Finally, participants will complete a series of questionnaires to evaluate pain, function, physical activity, footwear comfort and injury history. Participants will be randomized into either a wait list control group (no insole) or experimental group (medial or lateral wedged insole), and monitored for 3 months.

Changes to pain, function, comfort and physical activity from baseline to 3 months will be assessed within the control and experimental groups. Regression analyses will be conducted on the experimental group to determine if a relationship exists between reduced KAMs and reduced pain over 3 months. Comparisons will also be made between the control and experimental groups.

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 (Care Provider, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Physician-diagnosed knee osteoarthritis (using American College of Rheumatology clinical and radiographic criteria)
  • Kellgren-Lawrence grade 1, 2, 3 or 4
  • Primary symptoms and disease location must be attributed to medial tibiofemoral compartment
  • KOOS pain of 75 points or lower (where 0 is worst pain and 100 is no pain)

排除标准

  • X-ray older than 2 years
  • Viscosupplementation within past 6 months
  • Cortisone injection in past 3 months
  • Narcotic pain medication within past 3 months
  • Use of knee unloading brace interventions in past 2 months
  • Recent (past 6 months) knee or neuromuscular injury that could bias pain assessments or gait analysis results
  • No KAM reduction with either lateral or medial wedge insole

结局指标

主要结局

KOOS pain score

时间窗: baseline, 1-month, 2-months, 3-months

Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subsection

次要结局

  • Footwear Comfort(baseline)
  • PASE score(baseline, 1-month, 2-months, 3-months)
  • Knee biomechanics(baseline)
  • UCLA Physical Activity Score(baseline, 1-month, 2-months, 3-months)
  • Knee Adduction Moment(baseline)
  • Adiposity(baseline)
  • KOOS subsection and aggregate scores(baseline, 1-month, 2-months, 3-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ryan Lewinson

MD/PhD Candidate

University of Calgary

研究点 (2)

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