Knee OsteoarthritisNCT02388646
Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis
A study testing Exercise Only, Brace Only and Bracing + Exercises in people with Knee Osteoarthritis and Arthritis, run by Orthopaedic Research Foundation at 1 site in United States.
Trial summary
The goal of this study is to explore the effectiveness of a commercially available, over-the-counter knee brace in the conservative treatment of knee osteoarthritis. Participants will either be fitted with a brace and told to wear it every day during normal activities, fitted with the brace and given instructions on a… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Arthritis
- What is being tested?
- Exercise Only, Brace Only and Bracing + Exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is being treated for knee joint pain
- Subject is willing and able to comply with the evaluation schedule
Who cannot join
- Subject is undergoing surgery during the follow-up window that would limit their ability to comply with the evaluation schedule and/or significantly affect the outcomes measures
- Subject has current alcohol, opioid, or other drug dependence
- Subject is taking prescribed medication for pain other than in the knee joint (e.g. back pain)
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to explore the effectiveness of a commercially available, over-the-counter knee brace in the conservative treatment of knee osteoarthritis. Participants will either be fitted with a brace and told to wear it every day during normal activities, fitted with the brace and given instructions on a set of quadriceps strengthening exercises to complete twice daily, every day, or be given the exercise instructions, but not fitted with a brace. Functional and subjective outcomes will be collected preoperatively and at 6 and 12 weeks from baseline, with the goal of informing the effectiveness of bracing alone versus a home exercise program, and whether the combination of those provides the most therapeutic benefit to participants.
- Conditions
- Knee Osteoarthritis, Arthritis
- Being tested
- Exercise Only, Brace Only, Bracing + Exercises
- Medical subject headings
- Osteoarthritis, Knee, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise OnlyOther
This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group.
Brace OnlyDevice
This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living.
Bracing + ExercisesOther
This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Only | Active comparator | Home exercise program. Receives: Other: Exercise Only |
| Brace Only | Active comparator | Reaction Web brace. Receives: Device: Brace Only |
| Bracing + Exercises | Active comparator | Reaction Web brace and home exercises. Receives: Other: Bracing + Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pain Using the Visual Analog Scale
The Visual Analog Scale (VAS) consists of a 100mm horizontal line with the words "No Pain" (score of 0) and "Pain as bad as it could possibly be" (score of 100) written on opposite ends. Participants will be asked to mark on the line where their pain is in relation to the two extremes. Measurement is taken from the left-hand side of the line to the mark and reported as a score out of 100. The difference between the baseline score and score at the 3-month study visit was compared between study arms.
Measured: Baseline and 3-month Visit
Secondary outcomes (1)
Change in Quadriceps Force
Change in quadriceps force is the difference between average quadriceps force measurements (in Newtons) obtained at the 3-month postoperative follow-up minus the average quadriceps force measurement at baseline. Averages are stratified by study arm. Negative values indicate a reduction in quadriceps force from baseline to 3-month.
Measured: Baseline and 3-month Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopaedic Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank R Kolisek, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388646
- Sponsor's protocol ID
- FRKDJO-RWB-15
- Status last verified
- Apr 2021
- First submitted
- 4 Mar 2015
- Last updated
- 12 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be shared, only averages and summaries where all participant data is combined.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02388646
- Acronym / sponsor ID
- FRKDJO-RWB-15
- Conditions
- Knee Osteoarthritis, Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Orthopaedic Research FoundationUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Posted 12 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to explore the effectiveness of a commercially available, over-the-counter knee brace in the conservative treatment of knee osteoarthritis. Participants will either be fitted with a brace and told to wear it every day during normal activities, fitted with the brace and given instructions on a set of quadriceps strengthening exercises to complete twice daily, every day, or be given the exercise instructions, but not fitted with a brace. Functional and subjective outcomes will be collected preoperatively and at 6 and 12 weeks from baseline, with the goal of informing the effectiveness of bracing alone versus a home exercise program, and whether the combination of those provides the most therapeutic benefit to participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise Only | Active comparator | Other: Exercise OnlyHome exercise program. |
| Brace Only | Active comparator | Device: Brace OnlyReaction Web brace. |
| Bracing + Exercises | Active comparator | Other: Bracing + ExercisesReaction Web brace and home exercises. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject is being treated for knee joint pain
- Subject is willing and able to comply with the evaluation schedule
Key exclusion criteria (3 listed)
- Subject is undergoing surgery during the follow-up window that would limit their ability to comply with the evaluation schedule and/or significantly affect the outcomes measures
- Subject has current alcohol, opioid, or other drug dependence
- Subject is taking prescribed medication for pain other than in the knee joint (e.g. back pain)
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 |
|---|---|---|
| Exercise OnlyThis group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group. | Other | Exercise Only |
| Brace OnlyThis group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living. | Device | Brace Only |
| Bracing + ExercisesThis group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group. | Other | Bracing + Exercises |
Primary outcome
Assessment of Pain Using the Visual Analog Scale
Time frame: Baseline and 3-month Visit
The Visual Analog Scale (VAS) consists of a 100mm horizontal line with the words "No Pain" (score of 0) and "Pain as bad as it could possibly be" (score of 100) written on opposite ends. Participants will be asked to mark on the line where their pain is in relation to the two extremes. Measurement is taken from the left-hand side of the line to the mark and reported as a score out of 100. The difference between the baseline score and score at the 3-month study visit was compared between study arms.
1 secondary outcome
Change in Quadriceps Force
Time frame: Baseline and 3-month Visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data will not be shared, only averages and summaries where all participant data is combined.
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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.
Frank R Kolisek, MD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Only, Brace Only and Bracing + Exercises in people with Knee Osteoarthritis and Arthritis, run by Orthopaedic Research Foundation at 1 site 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 2 inclusion and 3 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 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 12 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Assessment of Pain Using the Visual Analog Scale (time frame: Baseline and 3-month Visit). 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 Apr 2021.