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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

Primary Purpose

Joint Instability

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dr. Scholl's Prototype Ankle Brace
Dr. Scholl's Prototype Knee Brace
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Joint Instability focused on measuring Pain, Ankle, Knee, Brace

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ankle/Knee brace

Arm Description

Dr. Scholl's Prototype Ankle or Knee Brace

Outcomes

Primary Outcome Measures

Comfort
Comfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale.
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.

Secondary Outcome Measures

Product Fit
Product Fit is assessed utilizing a 7-point scale.
Product Support
Support is assessed utilizing a 5-point scale.
Freedom of Movement
Freedom of Movement is assessed utilizing a 6-point scale.
Subjective Questions
Applicable subjective questions will be assessed utilizing the subjective questionnaire.

Full Information

First Posted
February 11, 2016
Last Updated
December 11, 2018
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02682654
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
February 5, 2016 (Actual)
Primary Completion Date
April 26, 2016 (Actual)
Study Completion Date
April 26, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Instability
Keywords
Pain, Ankle, Knee, Brace

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ankle/Knee brace
Arm Type
Experimental
Arm Description
Dr. Scholl's Prototype Ankle or Knee Brace
Intervention Type
Device
Intervention Name(s)
Dr. Scholl's Prototype Ankle Brace
Intervention Description
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
Intervention Name(s)
Dr. Scholl's Prototype Knee Brace
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comfort
Description
Comfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale.
Time Frame
Up to 15 days
Title
Pain Relief of Knee or Ankle joint
Description
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.
Time Frame
Up to 15 days
Secondary Outcome Measure Information:
Title
Product Fit
Description
Product Fit is assessed utilizing a 7-point scale.
Time Frame
Up to 15 days
Title
Product Support
Description
Support is assessed utilizing a 5-point scale.
Time Frame
Up to 15 days
Title
Freedom of Movement
Description
Freedom of Movement is assessed utilizing a 6-point scale.
Time Frame
Up to 15 days
Title
Subjective Questions
Description
Applicable subjective questions will be assessed utilizing the subjective questionnaire.
Time Frame
Up to 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80915
Country
United States
City
Richardson
State/Province
Texas
ZIP/Postal Code
75081
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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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