NCT02682654已完成不适用
A Multi-Site Evaluation of the Pain Relief, Support, Fit and Comfort From Use of a Custom Knee or Ankle Brace in Persons Suffering From Chronic Ankle or Knee Pain and Instability
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 183
- 试验地点
- 2
- 主要终点
- Comfort
研究概览
简要总结
This study will look to examine the overall performance of a custom fit knee or ankle brace as a means of providing ankle or knee joint support in subjects that have determined the need for bracing based upon chronic joint instability and/or joint swelling and pain following daily activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must indicate that they currently have weakened ankles or knees and that they experience chronic discomfort after performing daily activities.
- •Subjects must suffer from pain assessed on a 100 mm (10 cm) Visual Analog Scale (VAS) of ≥20 mm to ≤ 90 mm for subjects with either unstable ankle or unstable knee, at Visit 1 and
- •Subjects must be able to walk unaided by cane or walker.
- •Subjects must not have a noticeable limp or other permanent ailment that interferes with normal gait.
- •Subjects free of other types of health problems that, in the opinion of the Investigator, could influence their ability to participate.
- •If subjects are taking pain medication (prescription or Over-the-counter (OTC)) for a chronic condition, they may continue that medication as long as they have been on a stable dose for at least 2 months, and agree to continue their regular dose and regimen for the duration of the study.
- •Subjects must be willing to undergo a 1-week period without a brace and then willing to wear a brace for a 1-week period, that is: 8 ±2 hours a day for a minimum of 5 out of 7 days.
排除标准
- •Subjects with an ankle or knee pain and instability which is due to a recent sprains, strains, or other non-reversible injury to the knee or ankle.
- •Subjects who have diabetes, circulatory problems, open wounds, and lack of sensation in the ankles, knees, or feet or any problems that would make brace wear uncomfortable or inappropriate.
- •Subjects who wear a physician-prescribed orthotic device, prescription shoes or back braces.
- •Subjects who are undergoing traction or manipulative back adjustments or have had a traumatic injury to the lower extremity (deemed of non-overuse nature), which in the opinion of the examining Investigator would interfere with the study evaluations.
- •Subjects whose condition requires surgery or other medical intervention or who have undergone foot back or knee surgery within the past 3 months or with any planned surgeries and/or invasive medical procedures during the course of the study.
- •Subjects who are currently taking an opioid based pain medication or have taken such medication within 2 months prior to Visit
- •Subjects who are taking any chronic pain medication (prescription or OTC) for at least 2 months, who do not agree to continue taking it at the same dose and regimen throughout the study.
- •Subjects who have severely painful bunions, warts, corns and/or calluses, severely overlapping toes or lesions on the bottom of their foot.
- •Subjects who have sensitivities or allergies to plastics or adhesives.
研究组 & 干预措施
Ankle/Knee brace
Experimental
Dr. Scholl's Prototype Ankle or Knee Brace
干预措施: Dr. Scholl's Prototype Ankle Brace (Device)
Ankle/Knee brace
Experimental
Dr. Scholl's Prototype Ankle or Knee Brace
干预措施: Dr. Scholl's Prototype Knee Brace (Device)
结局指标
主要结局
Comfort
时间窗: Up to 15 days
Comfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale.
Pain Relief of Knee or Ankle joint
时间窗: Up to 15 days
Evaluation of Knee or Ankle joint pain will be performed using the Visual Analog Scale utilizing a 100 mm line defined at each end of the line by 0 = no pain and 100 = Worst pain possible.
次要结局
- Product Fit(Up to 15 days)
- Product Support(Up to 15 days)
- Freedom of Movement(Up to 15 days)
- Subjective Questions(Up to 15 days)
研究者
研究点 (2)
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