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

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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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Single Blind

183 participants in 1 patient group

Ankle/Knee brace
Experimental group
Description:
Dr. Scholl's Prototype Ankle or Knee Brace
Treatment:
Device: Dr. Scholl's Prototype Ankle Brace
Device: Dr. Scholl's Prototype Knee Brace

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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