Clinical trial NCT02067208: Wedged Insoles for Management of Knee Osteoarthritis
Official title: Reduced Knee Joint Loading With Lateral and Medial Wedge Insoles for Management of Knee Osteoarthritis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis
Cartilage
Musculoskeletal
Biomechanics
Subtype
Footwear
Orthotics
Joint Loading
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Natural Sciences and Engineering Research Council, Canada
name: Alberta Innovates Health Solutions
name: Killam Trusts
name: New Balance Athletic Shoe, Inc.
First posted: 2014-02-20
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: KOOS pain score
timeFrame: baseline, 1-month, 2-months, 3-months
Secondary outcomes:
measure: Adiposity
timeFrame: baseline
measure: Knee biomechanics
timeFrame: baseline
measure: PASE score
timeFrame: baseline, 1-month, 2-months, 3-months
measure: UCLA Physical Activity Score
timeFrame: baseline, 1-month, 2-months, 3-months
measure: Knee Adduction Moment
timeFrame: baseline
measure: Footwear Comfort
timeFrame: baseline
measure: KOOS subsection and aggregate scores
timeFrame: baseline, 1-month, 2-months, 3-months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Human Performance Laboratory, University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Ryan T Lewinson, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Kelsey HM Collins, BS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Isabelle A Vallerand, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: J Preston Wiley, MD, MPE
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Linda J Woodhouse, PhD, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Raylene A Reimer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Jay T Worobets, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Walter Herzog, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Darren J Stefanyshyn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Lewinson 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.