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

NCT ID: NCT02682654

Last Updated: 2018-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-05
• Study Completion Date: 2016-04-26

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.

Conditions

Joint Instability

Keywords

Pain; Ankle; Knee; Brace

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Ankle/Knee brace

Dr. Scholl's Prototype Ankle or Knee Brace

Group Type: EXPERIMENTAL

Dr. Scholl's Prototype Ankle Brace

Intervention Type: DEVICE

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.

Dr. Scholl's Prototype Knee Brace

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Colorado Springs, Colorado, United States

Richardson, Texas, United States

Countries

United States

Other Identifiers

18325

Identifier Type: -

Identifier Source: org_study_id