Clinical trial NCT02234895: 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
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: osteoarthritis
knee
biomechanics
treatment
symptoms
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Pedorthic Research Foundation of Canada
name: Kintec Footlabs
First posted: 2014-09-09
Enrollment: 26
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in knee joint load during walking: knee adduction moment
timeFrame: Baseline and 2 months
measure: Change in Knee Pain
timeFrame: Baseline and 2 Months
Secondary outcomes:
measure: Change in Self-Reported Physical Function
timeFrame: Baseline and 2 Months
measure: Change in Foot Pain
timeFrame: Baseline and 2 Months
Other outcomes:
measure: Participant perceived response to treatment
timeFrame: 2 Months
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia; University Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Michael A Hunt, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
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.