Knee OsteoarthritisNCT02067208
Wedged Insoles for Management of Knee Osteoarthritis
A study testing wedged insole in people with Knee Osteoarthritis, run by University of Calgary at 1 site in Canada.
Trial summary
Knee osteoarthritis (OA) is commonly treated using laterally wedged insoles. Although these insoles typically reduce knee abduction moments (KAM) - a variable associated with knee osteoarthritis - and thus are believed to be beneficial for OA management, recent research has indicated that in some cases lateral wedge… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- wedged insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Nov 2015
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician-diagnosed knee osteoarthritis (using American College of Rheumatology clinical and radiographic criteria)
- Kellgren-Lawrence grade 1, 2, 3 or 4
- Primary symptoms and disease location must be attributed to medial tibiofemoral compartment
- KOOS pain of 75 points or lower (where 0 is worst pain and 100 is no pain)
Who cannot join
- X-ray older than 2 years
- Viscosupplementation within past 6 months
- Cortisone injection in past 3 months
- Narcotic pain medication within past 3 months
- Use of knee unloading brace interventions in past 2 months
- Recent (past 6 months) knee or neuromuscular injury that could bias pain assessments or gait analysis results
- No KAM reduction with either lateral or medial wedge insole
Trial locations and contacts
1 site in 1 country.
Canada1 site
Human Performance Laboratory, University of Calgary
Calgary, Alberta, T2N 1N4
About this study
Official title: Reduced Knee Joint Loading With Lateral and Medial Wedge Insoles for Management of Knee Osteoarthritis: a Randomized Controlled Trial
Knee osteoarthritis (OA) is commonly treated using laterally wedged insoles. Although these insoles typically reduce knee abduction moments (KAM) - a variable associated with knee osteoarthritis - and thus are believed to be beneficial for OA management, recent research has indicated that in some cases lateral wedge insoles actually increase knee joint loads. In such cases, a medial wedge may be more appropriate.
The purpose of this study is to evaluate the influence of reduced KAMs on pain over 3-months for patients with knee OA. It is hypothesized that pain reduction will be directly related to KAM reduction.
Read more
Forty-six participants with knee OA will be recruited to participate. Each will undergo biomechanical gait analysis to determine the wedge type that most greatly reduces knee adduction moments. In addition, each participant will undergo a Dual Energy X-Ray Absorptiometry (DXA) scan to quantify adiposity. Finally, participants will complete a series of questionnaires to evaluate pain, function, physical activity, footwear comfort and injury history. Participants will be randomized into either a wait list control group (no insole) or experimental group (medial or lateral wedged insole), and monitored for 3 months.
Changes to pain, function, comfort and physical activity from baseline to 3 months will be assessed within the control and experimental groups. Regression analyses will be conducted on the experimental group to determine if a relationship exists between reduced KAMs and reduced pain over 3 months. Comparisons will also be made between the control and experimental groups.
- Conditions
- Knee Osteoarthritis
- Being tested
- wedged insole
- Keywords
- Osteoarthritis, Cartilage, Musculoskeletal, Biomechanics, Subtype, Footwear, Orthotics, Joint Loading
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wedged insoleDevice
Also called orthotic
Wedged insoles are designed to reduce frontal plane knee joint mechanical loads during gait. Specifically, they can alter the knee adduction moment during gait - a variable associated with progression of knee osteoarthritis. In the experimental arm of this study, participants will undergo biomechanical gait analysis to identify the wedged insole that reduces the moments the most. The two options are medial wedge, where the medial aspect of the foot is elevated relative to the lateral aspect, and the lateral wedge, where the lateral wedge is elevated relative to the medial aspect.
| Study group | Role | What they receive |
|---|---|---|
| Waitlist Control | No intervention | A waitlist control condition, where the participant receives no insole for 3 months. During this 3 month period, the participant will continue to be monitored for outcome variables. |
| Experimental wedged insole | Experimental | Either a medially wedged or laterally wedged footwear insole (whichever reduces knee joint mechanical loading more, as determined from subject-specific biomechanical tests), constructed using a 3D printer will be inserted into each participant's shoe. The participant will be asked to utilize this insole as much as possible throughout the day over the course of 3 months. Receives: Device: wedged insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS pain score
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subsection
Measured: baseline, 1-month, 2-months, 3-months
Secondary outcomes (7)
Adiposity
Measured using Dual Energy X-Ray Absorptiometry (DXA) scan
Measured: baseline
Knee biomechanics
Other knee joint mechanical variables assessed using motion analysis (ex. varus thrust, knee adduction impulse).
Measured: baseline
PASE score
Physical Activity Scale for the Elderly (PASE)
Measured: baseline, 1-month, 2-months, 3-months
UCLA Physical Activity Score
Scale evaluating physical activity levels
Measured: baseline, 1-month, 2-months, 3-months
Knee Adduction Moment
Calculated using inverse dynamics
Measured: baseline
Footwear Comfort
Evaluated using 100mm visual analog scale
Measured: baseline
KOOS subsection and aggregate scores
All other KOOS sections (excluding pain, which is primary outcome)
Measured: baseline, 1-month, 2-months, 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Natural Sciences and Engineering Research Council, Canada, Alberta Innovates Health Solutions, Killam Trusts, New Balance Athletic Shoe, Inc.
- Responsible party
- Principal investigator, Ryan Lewinson, University of Calgary
- Investigators
- Ryan T Lewinson, BSc, Principal investigator, University of CalgaryKelsey HM Collins, BS, Principal investigator, University of CalgaryIsabelle A Vallerand, BSc, Principal investigator, University of CalgaryJ Preston Wiley, MD, MPE, Principal investigator, University of CalgaryLinda J Woodhouse, PhD, PT, Principal investigator, University of AlbertaRaylene A Reimer, PhD, Principal investigator, University of CalgaryJay T Worobets, PhD, Principal investigator, University of CalgaryWalter Herzog, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067208
- Sponsor's protocol ID
- 23731-01
- Status last verified
- Nov 2015
- First submitted
- 18 Feb 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lewinson RT, Vallerand IA, Collins KH, Wiley JP, Lun VMY, Patel C, Woodhouse LJ, Reimer RA, Worobets JT, Herzog W, Stefanyshyn DJ. Reduced knee adduction moments for management of knee osteoarthritis:: A three month phase I/II randomized controlled trial. Gait Posture. 2016 Oct;50:60-68. doi: 10.1016/j.gaitpost.2016.08.027. Epub 2016 Aug 26.
PubMed 27580080Lewinson RT, Collins KH, Vallerand IA, Wiley JP, Woodhouse LJ, Reimer RA, Worobets JT, Herzog W, Stefanyshyn DJ. Reduced knee joint loading with lateral and medial wedge insoles for management of knee osteoarthritis: a protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2014 Dec 3;15:405. doi: 10.1186/1471-2474-15-405.
PubMed 25467955
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Knee Joint Loading With Lateral and Medial Wedge Insoles for Management of Knee Osteoarthritis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02067208
- Acronym / sponsor ID
- 23731-01
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Cartilage, Musculoskeletal, Biomechanics, Subtype, Footwear, Orthotics, Joint Loading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Natural Sciences and Engineering Research Council, Canada, Alberta Innovates Health Solutions, Killam Trusts, New Balance Athletic Shoe, Inc.
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 20 Feb 2014 (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.
Knee osteoarthritis (OA) is commonly treated using laterally wedged insoles. Although these insoles typically reduce knee abduction moments (KAM) - a variable associated with knee osteoarthritis - and thus are believed to be beneficial for OA management, recent research has indicated that in some cases lateral wedge insoles actually increase knee joint loads. In such cases, a medial wedge may be more appropriate.
The purpose of this study is to evaluate the influence of reduced KAMs on pain over 3-months for patients with knee OA. It is hypothesized that pain reduction will be directly related to KAM reduction.
Forty-six participants with knee OA will be recruited to participate. Each will undergo biomechanical gait analysis to determine the wedge type that most greatly reduces knee adduction moments. In addition, each participant will undergo a Dual Energy X-Ray Absorptiometry (DXA) scan to quantify adiposity. Finally, participants will complete a series of questionnaires to evaluate pain, function, physical activity, footwear comfort and injury history. Participants will be randomized into either a wait list control group (no insole) or experimental group (medial or lateral wedged insole), and monitored for 3 months.
Changes to pain, function, comfort and physical activity from baseline to 3 months will be assessed within the control and experimental groups. Regression analyses will be conducted on the experimental group to determine if a relationship exists between reduced KAMs and reduced pain over 3 months. Comparisons will also be made between the control and experimental groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlist Control | No intervention | –A waitlist control condition, where the participant receives no insole for 3 months. During this 3 month period, the participant will continue to be monitored for outcome variables. |
| Experimental wedged insole | Experimental | Device: wedged insoleEither a medially wedged or laterally wedged footwear insole (whichever reduces knee joint mechanical loading more, as determined from subject-specific biomechanical tests), constructed using a 3D printer will be inserted into each participant's shoe. The participant will be asked to utilize this insole as much as possible throughout the day over the course of 3 months. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Physician-diagnosed knee osteoarthritis (using American College of Rheumatology clinical and radiographic criteria)
- Kellgren-Lawrence grade 1, 2, 3 or 4
- Primary symptoms and disease location must be attributed to medial tibiofemoral compartment
- KOOS pain of 75 points or lower (where 0 is worst pain and 100 is no pain)
Key exclusion criteria (7 listed)
- X-ray older than 2 years
- Viscosupplementation within past 6 months
- Cortisone injection in past 3 months
- Narcotic pain medication within past 3 months
- Use of knee unloading brace interventions in past 2 months
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 |
|---|---|---|
| wedged insoleAlso: orthoticWedged insoles are designed to reduce frontal plane knee joint mechanical loads during gait. Specifically, they can alter the knee adduction moment during gait - a variable associated with progression of knee osteoarthritis. In the experimental arm of this study, participants will undergo biomechanical gait analysis to identify the wedged insole that reduces the moments the most. The two options are medial wedge, where the medial aspect of the foot is elevated relative to the lateral aspect, and the lateral wedge, where the lateral wedge is elevated relative to the medial aspect. | Device | Experimental wedged insole |
Primary outcome
KOOS pain score
Time frame: baseline, 1-month, 2-months, 3-months
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subsection
7 secondary outcomes
Adiposity
Time frame: baseline
Knee biomechanics
Time frame: baseline
PASE score
Time frame: baseline, 1-month, 2-months, 3-months
UCLA Physical Activity Score
Time frame: baseline, 1-month, 2-months, 3-months
Knee Adduction Moment
Time frame: baseline
Footwear Comfort
Time frame: baseline
KOOS subsection and aggregate scores
Time frame: baseline, 1-month, 2-months, 3-months
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 2 Dec 2015.
- Derived from this study: PubMed 27580080Lewinson RT, Vallerand IA, Collins KH, Wiley JP, Lun VMY, Patel C, Woodhouse LJ, Reimer RA, Worobets JT, Herzog W, Stefanyshyn DJ. Reduced knee adduction moments for management of knee osteoarthritis:: A three month phase I/II randomized controlled trial. Gait Posture. 2016 Oct;50:60-68. doi: 10.1016/j.gaitpost.2016.08.027. Epub 2016 Aug 26.
- Derived from this study: PubMed 25467955Lewinson RT, Collins KH, Vallerand IA, Wiley JP, Woodhouse LJ, Reimer RA, Worobets JT, Herzog W, Stefanyshyn DJ. Reduced knee joint loading with lateral and medial wedge insoles for management of knee osteoarthritis: a protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2014 Dec 3;15:405. doi: 10.1186/1471-2474-15-405.
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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.
Ryan T Lewinson, BSc principal investigator
University of Calgary
Kelsey HM Collins, BS principal investigator
University of Calgary
Isabelle A Vallerand, BSc principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wedged insole in people with Knee Osteoarthritis, run by University of Calgary at 1 site in Canada.
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 4 inclusion and 7 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 2 Dec 2015. 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 Canada. 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?
KOOS pain score (time frame: baseline, 1-month, 2-months, 3-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02067208, which also lists 2 linked publications.
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 2 Dec 2015.