Clinical trial NCT02682654: 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
Overall status: COMPLETED
Phase: NA
Conditions: Joint Instability
Keywords: Pain
Ankle
Knee
Brace
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-02-15
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Comfort
timeFrame: Up to 15 days
measure: Pain Relief of Knee or Ankle joint
timeFrame: Up to 15 days
Secondary outcomes:
measure: Product Fit
timeFrame: Up to 15 days
measure: Product Support
timeFrame: Up to 15 days
measure: Freedom of Movement
timeFrame: Up to 15 days
measure: Subjective Questions
timeFrame: Up to 15 days
Other outcomes:
Locations:
city: Colorado Springs
country: United States
state: Colorado
city: Richardson
country: United States
state: Texas
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: