Joint InstabilityNCT02682654
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
A study testing Dr. Scholl's Prototype Ankle Brace and Dr. Scholl's Prototype Knee Brace in people with Joint Instability, run by Bayer at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Joint Instability
- What is being tested?
- Dr. Scholl's Prototype Ankle Brace and Dr. Scholl's Prototype Knee Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Feb 2016to 26 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Colorado Springs, Colorado, 80915
Study site
Richardson, Texas, 75081
About this study
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.
- Conditions
- Joint Instability
- Being tested
- Dr. Scholl's Prototype Ankle Brace, Dr. Scholl's Prototype Knee Brace
- Keywords
- Pain, Ankle, Knee, Brace
- Medical subject headings
- Joint Instability, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dr. Scholl's Prototype Ankle BraceDevice
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.
Dr. Scholl's Prototype Knee BraceDevice
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 group | Role | What they receive |
|---|---|---|
| Ankle/Knee brace | Experimental | Dr. Scholl's Prototype Ankle or Knee Brace Receives: Device: Dr. Scholl's Prototype Ankle Brace; Device: Dr. Scholl's Prototype Knee Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
Comfort is assessed utilizing a 7-point Comfort/Discomfort Likert scale.
Measured: Up to 15 days
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.
Measured: Up to 15 days
Secondary outcomes (4)
Product Fit
Product Fit is assessed utilizing a 7-point scale.
Measured: Up to 15 days
Product Support
Support is assessed utilizing a 5-point scale.
Measured: Up to 15 days
Freedom of Movement
Freedom of Movement is assessed utilizing a 6-point scale.
Measured: Up to 15 days
Subjective Questions
Applicable subjective questions will be assessed utilizing the subjective questionnaire.
Measured: Up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study start5 Feb 2016
- Primary completion26 Apr 2016
- Study completion26 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint InstabilityStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682654
- Sponsor's protocol ID
- 18325
- Status last verified
- Dec 2018
- First submitted
- 11 Feb 2016
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02682654
- Acronym / sponsor ID
- 18325
- Conditions
- Joint Instability
- Keywords
- Pain, Ankle, Knee, Brace
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2016 (actual)
- Primary completion
- 26 Apr 2016 (actual)
- Study completion
- 26 Apr 2016 (actual)
- First posted
- 15 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ankle/Knee brace | Experimental | Device: Dr. Scholl's Prototype Ankle Brace, Device: Dr. Scholl's Prototype Knee BraceDr. Scholl's Prototype Ankle or Knee Brace |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dr. Scholl's Prototype Ankle BraceSubjects 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 | Ankle/Knee brace |
| Dr. Scholl's Prototype Knee BraceSubjects 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 | Ankle/Knee brace |
Primary outcome
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.
4 secondary outcomes
Product Fit
Time frame: Up to 15 days
Product Support
Time frame: Up to 15 days
Freedom of Movement
Time frame: Up to 15 days
Subjective Questions
Time frame: Up to 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dr. Scholl's Prototype Ankle Brace and Dr. Scholl's Prototype Knee Brace in people with Joint Instability, run by Bayer at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort (time frame: Up to 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2018.