Shoe Orthotics for Improvement of Biomechanics and Symptoms of Knee Osteoarthritis
Combined Medial and Lateral Orthotics for the Treatment of Knee Osteoarthritis
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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British Columbia
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Vancouver, British Columbia, Kanada
- University of British Columbia; University Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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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.
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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.
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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.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Change in knee joint load during walking: knee adduction moment
Zeitfenster: Baseline and 2 months
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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
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Change in Knee Pain
Zeitfenster: Baseline and 2 Months
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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.
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Baseline and 2 Months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Self-Reported Physical Function
Zeitfenster: Baseline and 2 Months
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The physical function subscale (17 questions) on the WOMAC will be used.
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Baseline and 2 Months
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Change in Foot Pain
Zeitfenster: Baseline and 2 Months
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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
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Baseline and 2 Months
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Participant perceived response to treatment
Zeitfenster: 2 Months
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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'
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2 Months
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Michael A Hunt, PhD, PT, University of British Columbia
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- H14-01313
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