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

NCT02682654 | Completed

• 1 other identifier: 18325
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Product Fit

  Up to 15 days

• Product Support

  Up to 15 days

• Freedom of Movement

  Up to 15 days

• Subjective Questions

  Up to 15 days

Study Arms (1)

Ankle/Knee brace

EXPERIMENTAL

Dr. Scholl's Prototype Ankle or Knee Brace

Device: Dr. Scholl's Prototype Ankle Brace; Device: Dr. Scholl's Prototype Knee Brace

Interventions

Dr. Scholl's Prototype Ankle Brace 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.

Ankle/Knee brace

Dr. Scholl's Prototype Knee Brace 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.

Ankle/Knee brace

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

Unknown Facility

Colorado Springs, Colorado, 80915, United States

Location

Unknown Facility

Richardson, Texas, 75081, United States

Location

MeSH Terms

Conditions

Joint Instability; Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 15, 2016
• Study Start: February 5, 2016
• Primary Completion: April 26, 2016
• Study Completion: April 26, 2016
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

US (2)