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临床试验/NCT00105365
NCT00105365已完成不适用

Shoe Modification and Knee Osteoarthritis

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2004年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
WOMAC pain scale

研究概览

简要总结

This trial will assess the ability of shoe inserts to relieve pain and disability in people with knee osteoarthritis (OA) in the inner (medial) aspect of the knee.

详细描述

Osteoarthritis (OA), the most common joint disease in humans, is a significant cause of pain and disability. Its prevalence increases with age, leading to about 65-85% of those age 65 years and older having OA. Involvement of the knee with OA is the main reason for significant functional impairment as it alters ambulation through pain and stiffness. Nonpharmacological management of knee OA includes the use of orthotic supports such as wedged insoles for varus or valgus knee deformities to relieve pain and improve function in the early stages of this joint disease. Although these interventions are desirable because they are simple and inexpensive, we do not have a clear understanding about their efficacy in relieving pain and disability in people with knee OA. We also do not know whether there is a relationship between changes in joint biomechanics that occur with wedged insoles and changes in function and progression of OA. Furthermore, information is lacking regarding which patients would benefit from wedged insoles. Answering these questions will be critically important in the development of guidelines for the prescription of wedged insoles in knee OA. Patients in this study will be evaluated at baseline and after wearing the lateral-wedged insoles immediately and after wearing the insoles for four weeks. The participants will wear lateral-wedged insoles for the painful knee(s) for as many hours and for as many days of the week as they can tolerate. Some subjects may use a neutral position insole for an asymptomatic knee.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Ability to walk 30 feet without a walking aid
  • Ability to stand unaided
  • Ability to understand verbal instructions
  • Ability to give informed consent

排除标准

  • History of knee trauma or surgery including arthroscopic surgery in the past 6 months
  • Severe obesity (>30 kg/m2)
  • Neurological disease
  • Injury or amputation to the lower extremity joints
  • History of other types of arthritis
  • Symptomatic spine, hip, ankle, or foot disease that would interfere with assessment of the knee
  • Intra-articular steroids in the past 3 months, or hyaluronic acid in the last 6 months
  • Poor health that would impair compliance or assessment such as shortness of breath with exertion

研究组 & 干预措施

walking shoes

Placebo Comparator

walking shoes

干预措施: walking shoes (Other)

walking shoes + shoe insert

Experimental

walking shoes + shoe insert

干预措施: Shoe insert (Device)

结局指标

主要结局

WOMAC pain scale

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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