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
Not Applicable
Completed
- Conditions
- Joint Instability
- Registration Number
- NCT02682654
- Lead Sponsor
- Bayer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 183
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.
- 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 1.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Comfort Up to 15 days Comfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale.
Pain Relief of Knee or Ankle joint 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.
- Secondary Outcome Measures
Name Time Method Product Fit Up to 15 days Product Fit is assessed utilizing a 7-point scale.
Product Support Up to 15 days Support is assessed utilizing a 5-point scale.
Freedom of Movement Up to 15 days Freedom of Movement is assessed utilizing a 6-point scale.
Subjective Questions Up to 15 days Applicable subjective questions will be assessed utilizing the subjective questionnaire.