check_circleStudy Completed

Joint instability

Bayer Identifier:

18325

ClinicalTrials.gov Identifier:

NCT02682654

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years
  • -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.
  • -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 summary

Enrollment Goal
183
Trial Dates
February 2016 - April 2016
Phase
N/A
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Richardson, 75081, United States
Completed
Colorado Springs, 80915, United States

Primary Outcome

  • Comfort
    Comfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale.
    date_rangeTime Frame:
    Up to 15 days
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    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Up to 15 days
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    Safety Issue:
    No

Secondary Outcome

  • Product Fit
    Product Fit is assessed utilizing a 7-point scale.
    date_rangeTime Frame:
    Up to 15 days
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    Safety Issue:
    No
  • Product Support
    Support is assessed utilizing a 5-point scale.
    date_rangeTime Frame:
    Up to 15 days
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    Safety Issue:
    No
  • Freedom of Movement
    Freedom of Movement is assessed utilizing a 6-point scale.
    date_rangeTime Frame:
    Up to 15 days
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    Safety Issue:
    No
  • Subjective Questions
    Applicable subjective questions will be assessed utilizing the subjective questionnaire.
    date_rangeTime Frame:
    Up to 15 days
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Device
Trial Purpose
Supportive Care
Allocation
N/A
Blinding
Single Blind
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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