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Shoe Orthotics for Improvement of Biomechanics and Symptoms of Knee Osteoarthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02234895
First Posted: September 9, 2014
Last Update Posted: June 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Pedorthic Research Foundation of Canada
Kintec Footlabs
Information provided by (Responsible Party):
University of British Columbia
  Purpose
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.

Condition Intervention
Knee Osteoarthritis Device: Lateral wedge Device: Lateral wedge plus medial arch support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Medial and Lateral Orthotics for the Treatment of Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Change in knee joint load during walking: knee adduction moment [ Time Frame: Baseline and 2 months ]

    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 [ Time Frame: Baseline and 2 Months ]
    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 [ Time Frame: Baseline and 2 Months ]
    The physical function subscale (17 questions) on the WOMAC will be used.

  • Change in Foot Pain [ Time Frame: Baseline and 2 Months ]
    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


Other Outcome Measures:
  • Participant perceived response to treatment [ Time Frame: 2 Months ]
    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'


Enrollment: 26
Study Start Date: August 2014
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lateral wedge plus medial arch support
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.
Device: Lateral wedge plus medial arch support
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.
Experimental: Lateral wedge
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.
Device: Lateral wedge
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234895


Locations
Canada, British Columbia
University of British Columbia; University Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Pedorthic Research Foundation of Canada
Kintec Footlabs
Investigators
Principal Investigator: Michael A Hunt, PhD, PT University of British Columbia
  More Information

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02234895     History of Changes
Other Study ID Numbers: H14-01313
First Submitted: September 4, 2014
First Posted: September 9, 2014
Last Update Posted: June 8, 2016
Last Verified: June 2016

Keywords provided by University of British Columbia:
osteoarthritis
knee
biomechanics
treatment
symptoms

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases