Shoe Orthotics for Improvement of Biomechanics and Symptoms of Knee Osteoarthritis

NCT02234895 | Completed

• 1 other identifier: H14-01313
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

osteoarthritis; knee; biomechanics; treatment; symptoms

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and 2 months

• 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.

  Baseline and 2 Months

Secondary Outcomes (2)

• Change in Self-Reported Physical Function

  Baseline and 2 Months

• Change in Foot Pain

  Baseline and 2 Months

Other Outcomes (1)

• Participant perceived response to treatment

  2 Months

Study Arms (2)

Lateral wedge plus medial arch support

EXPERIMENTAL

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

Lateral wedge

EXPERIMENTAL

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

Interventions

Lateral wedge DEVICE

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.

Lateral wedge

Lateral wedge plus medial arch support DEVICE

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.

Lateral wedge plus medial arch support

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead
• Kintec Footlabs: collaborator
• Pedorthic Research Foundation of Canada: collaborator

Study Sites (1)

University of British Columbia; University Hospital

Vancouver, British Columbia, Canada

Location

Related Publications (1)

• 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.

  PMID: 28473871 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Michael A Hunt, PhD, PT

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 9, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 8, 2016

Record last verified: 2016-06

Locations

CA (1)