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

Bayer

Status

Completed

Conditions

Joint Instability

Treatments

Device: Dr. Scholl's Prototype Knee Brace

Device: Dr. Scholl's Prototype Ankle Brace

Study type

Interventional

Funder types

Industry

Identifiers

NCT02682654

18325

Details and patient eligibility

About

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.

Enrollment

183 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.