Back to resultsShoe Orthotics for Improvement of Biomechanics and Symptoms of Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lateral wedge
Lateral wedge plus medial arch support
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring osteoarthritis, knee, biomechanics, treatment, symptoms
Eligibility Criteria
Inclusion Criteria:
i) age 50 - 80 years (to meet the American College of Rheumatology clinical definition of OA)
ii) medial tibiofemoral OA, defined as medial knee pain on most days of the past month and evidence on radiographs of a definite osteophyte in the medial tibiofemoral compartment
iii) pronated feet, defined as a foot posture index that is 0.5 standard deviations above the reported population mean.
Exclusion Criteria:
i) low pain score on a numerical rating scale of pain (average knee pain on walking ≤3 out of 10 over previous week) to allow detection of treatment response
ii) knee surgery or intra-articular corticosteroid injection within the previous six months
iii) current or recent (within 4 weeks) oral corticosteroid use
iv) any muscular, joint or neurological condition affecting lower limb within the past 6 months
v) ankle/foot pathology or pain that precludes the use of orthotics
vi) current use of foot orthotics
vii) use of footwear unable to accommodate an orthotic
viii) unable to walk without a gait aid
ix) inability to speak English or have a family member present to translate (required for the validity of the questionnaires)
Sites / Locations
- University of British Columbia; University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lateral wedge plus medial arch support
Lateral wedge
Arm Description
The lateral wedge plus medial support orthotic will be custom-made and designed using a 3D volumetric cast of the foot with the participant's foot in a subtalar joint neutral position. The cast will be balanced so that it rests in a neutral position then smoothed to address any irregularities and to allow for soft tissue splay. Polypropylene sheets of 3mm or 4mm thickness will be vacuum formed or milled directly to produce a ¾ length shell. An ethyl-vinyl-acetone (EVA) lateral post in the heel and forefoot of 5 degrees will be incorporated into the orthotic. The orthotic will be finished with a neoprene cover for improved comfort and patient compliance.
The lateral wedge only orthotic will be constructed of EVA, made to full length of the subject's footwear and incorporate a 5 degree posting. The wedge will be finished with a neoprene cover for improved comfort and patient compliance.
Outcomes
Primary Outcome Measures
Change in knee joint load during walking: knee adduction moment
Participants will undergo three-dimensional gait analysis. This will be performed barefoot with and without the orthotics (conditions tested in a random order). Kinematic and kinetic data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. Participants will be instructed to walk at a self-selected walking speed measured using photoelectric timing gates and placed along the walkway two metres on either side of the force platforms (note that walking speed during follow-up assessments will be kept similar (+/- 5%) to that chosen by each participant at baseline). A total of five trials will be collected.
The primary loading variable will be the KAM impulse - defined as the area under the KAM curve. Rather than a single peak value, the KAM impulse is more reflective of load experienced over the duration of stance and reflects the cumulative loading experienced at the knee during walking.
Change in Knee Pain
The WOMAC is a disease-specific questionnaire that quantifies self-reported joint pain, joint stiffness, and physical function. It is a valid, reliable, and responsive outcome measure that is recommended for use in osteoarthritis clinical trials.
Secondary Outcome Measures
Change in Self-Reported Physical Function
The physical function subscale (17 questions) on the WOMAC will be used.
Change in Foot Pain
Participants will rate their perceived foot function and pain using the Foot Function Index (revised - short form). This is a self-report questionnaire which consists of 34 items and provides the ability to quantify aspects of pain, disability and activity limitation. Such assessment of pain has been widely used and is a valid and reliable method in clinical research studies
Full Information
NCT ID
NCT02234895
First Posted
September 4, 2014
Last Updated
June 6, 2016
Sponsor
University of British Columbia
Collaborators
Pedorthic Research Foundation of Canada, Kintec Footlabs
1. Study Identification
Unique Protocol Identification Number
NCT02234895
Brief Title
Shoe Orthotics for Improvement of Biomechanics and Symptoms of Knee Osteoarthritis
Official Title
Combined Medial and Lateral Orthotics for the Treatment of Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Pedorthic Research Foundation of Canada, Kintec Footlabs
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Knee osteoarthritis (OA) is a widespread problem in Canada, leading to decreased quality of life and increased economic burden. Current research has focused on expensive, invasive treatments, whereas inexpensive conservative treatments have received less attention. One such treatment is the use of orthotics to reduce pain and increase function in people with knee OA. Currently, clinical practice guidelines for the use of orthotics are vague and contradictory, and could benefit from more research taking into account foot posture. This study aims to compare the use of two orthotics designs in people with knee OA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
osteoarthritis, knee, biomechanics, treatment, symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lateral wedge plus medial arch support
Arm Type
Experimental
Arm Description
The lateral wedge plus medial support orthotic will be custom-made and designed using a 3D volumetric cast of the foot with the participant's foot in a subtalar joint neutral position. The cast will be balanced so that it rests in a neutral position then smoothed to address any irregularities and to allow for soft tissue splay. Polypropylene sheets of 3mm or 4mm thickness will be vacuum formed or milled directly to produce a ¾ length shell. An ethyl-vinyl-acetone (EVA) lateral post in the heel and forefoot of 5 degrees will be incorporated into the orthotic. The orthotic will be finished with a neoprene cover for improved comfort and patient compliance.
Arm Title
Lateral wedge
Arm Type
Experimental
Arm Description
The lateral wedge only orthotic will be constructed of EVA, made to full length of the subject's footwear and incorporate a 5 degree posting. The wedge will be finished with a neoprene cover for improved comfort and patient compliance.
Intervention Type
Device
Intervention Name(s)
Lateral wedge
Intervention Description
This will be a randomized cross-over study where all participants will receive both orthoses over a six month period. Each intervention will last two months, separated by a two month washout period of no orthotics wear, and will be preceded and followed by a laboratory-based gait and pain assessment. Two months has been chosen as the ideal time frame to ensure maximum participant adherence, to observe clinically meaningful changes in symptoms, and to minimize degradation of the insoles.
Intervention Type
Device
Intervention Name(s)
Lateral wedge plus medial arch support
Intervention Description
This will be a randomized cross-over study where all participants will receive both orthoses over a six month period. Each intervention will last two months, separated by a two month washout period of no orthotics wear, and will be preceded and followed by a laboratory-based gait and pain assessment. Two months has been chosen as the ideal time frame to ensure maximum participant adherence, to observe clinically meaningful changes in symptoms, and to minimize degradation of the insoles.
Primary Outcome Measure Information:
Title
Change in knee joint load during walking: knee adduction moment
Description
Participants will undergo three-dimensional gait analysis. This will be performed barefoot with and without the orthotics (conditions tested in a random order). Kinematic and kinetic data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. Participants will be instructed to walk at a self-selected walking speed measured using photoelectric timing gates and placed along the walkway two metres on either side of the force platforms (note that walking speed during follow-up assessments will be kept similar (+/- 5%) to that chosen by each participant at baseline). A total of five trials will be collected.
The primary loading variable will be the KAM impulse - defined as the area under the KAM curve. Rather than a single peak value, the KAM impulse is more reflective of load experienced over the duration of stance and reflects the cumulative loading experienced at the knee during walking.
Time Frame
Baseline and 2 months
Title
Change in Knee Pain
Description
The WOMAC is a disease-specific questionnaire that quantifies self-reported joint pain, joint stiffness, and physical function. It is a valid, reliable, and responsive outcome measure that is recommended for use in osteoarthritis clinical trials.
Time Frame
Baseline and 2 Months
Secondary Outcome Measure Information:
Title
Change in Self-Reported Physical Function
Description
The physical function subscale (17 questions) on the WOMAC will be used.
Time Frame
Baseline and 2 Months
Title
Change in Foot Pain
Description
Participants will rate their perceived foot function and pain using the Foot Function Index (revised - short form). This is a self-report questionnaire which consists of 34 items and provides the ability to quantify aspects of pain, disability and activity limitation. Such assessment of pain has been widely used and is a valid and reliable method in clinical research studies
Time Frame
Baseline and 2 Months
Other Pre-specified Outcome Measures:
Title
Participant perceived response to treatment
Description
At follow-up for each orthotic, participants will rate overall perceived change in pain and physical function (vs. baseline) on an ordinal scale (1-much worse, 2-slightly worse, 3-same, 4-slightly better, 5-much better). This will be dichotomized into 'improvement' (4 and 5) or 'no improvement'
Time Frame
2 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
i) age 50 - 80 years (to meet the American College of Rheumatology clinical definition of OA)
ii) medial tibiofemoral OA, defined as medial knee pain on most days of the past month and evidence on radiographs of a definite osteophyte in the medial tibiofemoral compartment
iii) pronated feet, defined as a foot posture index that is 0.5 standard deviations above the reported population mean.
Exclusion Criteria:
i) low pain score on a numerical rating scale of pain (average knee pain on walking ≤3 out of 10 over previous week) to allow detection of treatment response
ii) knee surgery or intra-articular corticosteroid injection within the previous six months
iii) current or recent (within 4 weeks) oral corticosteroid use
iv) any muscular, joint or neurological condition affecting lower limb within the past 6 months
v) ankle/foot pathology or pain that precludes the use of orthotics
vi) current use of foot orthotics
vii) use of footwear unable to accommodate an orthotic
viii) unable to walk without a gait aid
ix) inability to speak English or have a family member present to translate (required for the validity of the questionnaires)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Hunt, PhD, PT
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia; University Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
28473871
Citation
Hunt MA, Takacs J, Krowchuk NM, Hatfield GL, Hinman RS, Chang R. Lateral wedges with and without custom arch support for people with medial knee osteoarthritis and pronated feet: an exploratory randomized crossover study. J Foot Ankle Res. 2017 May 2;10:20. doi: 10.1186/s13047-017-0201-x. eCollection 2017.
Results Reference
derived
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Shoe Orthotics for Improvement of Biomechanics and Symptoms of Knee Osteoarthritis
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