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

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.

Study Overview

• Status: Completed
• Conditions: Joint Instability
• Intervention / Treatment: Device: Dr. Scholl's Prototype Ankle Brace; Device: Dr. Scholl's Prototype Knee Brace

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80915
  • Texas
    • Richardson, Texas, United States, 75081

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ankle/Knee brace; Dr. Scholl's Prototype Ankle or Knee Brace	Device: Dr. Scholl's Prototype Ankle Brace; Subjects will be instructed to wear the assigned Ankle/Knee brace for 8 ± 2 hours per day, for a minimun of 5 days out of a 7-day/1 week wear period.; Device: Dr. Scholl's Prototype Knee Brace; Subjects will be instructed to wear the assigned Ankle/Knee brace for 8 ± 2 hours per day, for a minimun of 5 days out of a 7-day/1 week wear period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort	Comfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale.	Up to 15 days
Pain Relief of Knee or Ankle joint	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.	Up to 15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Product Fit	Product Fit is assessed utilizing a 7-point scale.	Up to 15 days
Product Support	Support is assessed utilizing a 5-point scale.	Up to 15 days
Freedom of Movement	Freedom of Movement is assessed utilizing a 6-point scale.	Up to 15 days
Subjective Questions	Applicable subjective questions will be assessed utilizing the subjective questionnaire.	Up to 15 days

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2016
• Primary Completion (Actual): April 26, 2016
• Study Completion (Actual): April 26, 2016

Study Registration Dates

• First Submitted: February 11, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimate): February 15, 2016

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Pain; Knee; Brace; Ankle
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Joint Instability
• Other Study ID Numbers: 18325

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No