Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Joint Instability Device: Dr. Scholl's Prototype Ankle Brace Device: Dr. Scholl's Prototype Knee Brace Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
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
Actual Study Start Date : February 5, 2016
Actual Primary Completion Date : April 26, 2016
Actual Study Completion Date : April 26, 2016

Arm Intervention/treatment
Experimental: Ankle/Knee brace
Dr. Scholl's Prototype Ankle or Knee Brace
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.




Primary Outcome Measures :
  1. Comfort [ Time Frame: Up to 15 days ]
    Comfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale.

  2. 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.


Secondary Outcome Measures :
  1. Product Fit [ Time Frame: Up to 15 days ]
    Product Fit is assessed utilizing a 7-point scale.

  2. Product Support [ Time Frame: Up to 15 days ]
    Support is assessed utilizing a 5-point scale.

  3. Freedom of Movement [ Time Frame: Up to 15 days ]
    Freedom of Movement is assessed utilizing a 6-point scale.

  4. Subjective Questions [ Time Frame: Up to 15 days ]
    Applicable subjective questions will be assessed utilizing the subjective questionnaire.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682654


Locations
Layout table for location information
United States, Colorado
Colorado Springs, Colorado, United States, 80915
United States, Texas
Richardson, Texas, United States, 75081
Sponsors and Collaborators
Bayer
Investigators
Layout table for investigator information
Study Director: Bayer Study Director Bayer
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02682654    
Other Study ID Numbers: 18325
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Pain
Ankle
Knee
Brace
Additional relevant MeSH terms:
Layout table for MeSH terms
Joint Instability
Joint Diseases
Musculoskeletal Diseases