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Shoe Orthotics for Improvement of Biomechanics and Symptoms of Knee Osteoarthritis

6 juni 2016 bijgewerkt door: University of British Columbia

Combined Medial and Lateral Orthotics for the Treatment of Knee Osteoarthritis

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

26

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • University of British Columbia; University Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: 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.
Experimenteel: 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.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in knee joint load during walking: knee adduction moment
Tijdsspanne: 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.
Baseline and 2 months
Change in Knee Pain
Tijdsspanne: 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.
Baseline and 2 Months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Self-Reported Physical Function
Tijdsspanne: Baseline and 2 Months
The physical function subscale (17 questions) on the WOMAC will be used.
Baseline and 2 Months
Change in Foot Pain
Tijdsspanne: 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
Baseline and 2 Months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Participant perceived response to treatment
Tijdsspanne: 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'
2 Months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of British Columbia

Medewerkers

Pedorthic Research Foundation of Canada
Kintec Footlabs

Onderzoekers

  • Hoofdonderzoeker: Michael A Hunt, PhD, PT, University of British Columbia

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 augustus 2014

Primaire voltooiing (Werkelijk)

1 maart 2016

Studie voltooiing (Werkelijk)

1 maart 2016

Studieregistratiedata

Eerst ingediend

4 september 2014

Eerst ingediend dat voldeed aan de QC-criteria

4 september 2014

Eerst geplaatst (Schatting)

9 september 2014

Updates van studierecords

Laatste update geplaatst (Schatting)

8 juni 2016

Laatste update ingediend die voldeed aan QC-criteria

6 juni 2016

Laatst geverifieerd

1 juni 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • H14-01313

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