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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02682654
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE February 11, 2016
First Posted Date  ICMJE February 15, 2016
Last Update Posted Date December 12, 2018
Actual Study Start Date  ICMJE February 5, 2016
Actual Primary Completion Date April 26, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
  • Comfort [ Time Frame: Up to 15 days ]
    Comfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale.
  • Pain Relief of Knee or Ankle joint [ Time Frame: Up to 15 days ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
  • Product Fit [ Time Frame: Up to 15 days ]
    Product Fit is assessed utilizing a 7-point scale.
  • Product Support [ Time Frame: Up to 15 days ]
    Support is assessed utilizing a 5-point scale.
  • Freedom of Movement [ Time Frame: Up to 15 days ]
    Freedom of Movement is assessed utilizing a 6-point scale.
  • Subjective Questions [ Time Frame: Up to 15 days ]
    Applicable subjective questions will be assessed utilizing the subjective questionnaire.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Joint Instability
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: Ankle/Knee brace
Dr. Scholl's Prototype Ankle or Knee Brace
Interventions:
  • Device: Dr. Scholl's Prototype Ankle Brace
  • Device: Dr. Scholl's Prototype Knee Brace
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2016)
183
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2016)
192
Actual Study Completion Date  ICMJE April 26, 2016
Actual Primary Completion Date April 26, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02682654
Other Study ID Numbers  ICMJE 18325
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP