A Multi-Site Evaluation of the Pain Relief, Support, Fit and Comfort From Use of a Custom Knee or… (NCT02682654) | Clinical Trial Compass
CompletedNot Applicable
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
United States183 participantsStarted 2016-02-05
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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 2.
* 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.
Exclusion Criteria:
* 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.
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