Effectiveness of Lateral Wedge Insole on Knee Osteoarthritis Outcomes in Pakistani Population
26. Oktober 2021 aktualisiert von: Rabbiya Riaz, Isra University
Osteoarthritis (OA) is a persistent joint disorder, which normally affects the weight bearing joints especially knee joint.
Lateral wedge insole is one such approach suggested by professionals to manage the knee osteoarthritis.Effectiveness of lateral wedge insoles (LWI) group (n=20), and conventional physical therapy (CPT) group (n=20) with home exercises as baseline treatment were assessed on Urdu version of Knee Injury and Osteoarthritis Outcome Score scale (KOOS).
Studienübersicht
Status
Abgeschlossen
Detaillierte Beschreibung
A total of n=104 patients were recruited through the non-probability convenience sampling technique and were thus evaluated for the inclusion criteria.
Of which, n=40 participants fulfilled the inclusion criteria.
Participants were randomly divided through the sealed envelope method in two groups; lateral wedge insoles with home exercises group (n=20), and traditional physiotherapy with home exercises group (n=20).
The data was collected through a general demographic questionnaire and Knee injury and Osteoarthritis Outcome Score (KOOS) in Urdu to determine the severity of pain, stiffness, functional activities, recreational activities and Quality of life to promote functional independence in osteoarthritic patients.[20]
The level of significance was set at p<0.05.
Statistical Package for the Social Sciences (SPSS) ver.
23 was used for data analysis.As the assumption of the parametric test was met, mixed ANOVA was used for the interaction effect of between-subject factor (group) and within-subject factor (time).
With-in group analysis and one way ANOVA was used for between-group comparisons to determine the effect size (ɳp2).
Studientyp
Interventionell
Einschreibung (Tatsächlich)
40
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Punjab
-
Islamabad, Punjab, Pakistan
- Rabbiya Riaz
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
40 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Patients with the age criteria of 40-70 years, and who had a history of knee OA were included in the study.
Exclusion Criteria:
- Patients had knee OA due to trauma or any pathology, multiple fractures, or had a medical condition due to which rehabilitation wasn't possible, and not willing to participate in the clinical trials were excluded from the study.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Lateral wedge insoles with home exercises group(Group 1)
In this group, participants were advised to use lateral wedge insole during walking and long-standing.
Non customized full-length lateral wedge insoles of 7mm made of silicon material with 5 degrees angulation (because greater wedging is associated with foot discomfort) was used.
Full-length wedge extends under the lesser metatarsal heads which increases the lever arm for rearfoot eversion and thus can prevent subtalar joint rotation.
The evaluations were performed every week till fourth week.
|
In this group, participants were advised to use lateral wedge insole during walking and long-standing.
Non customized full-length lateral wedge insoles of 7mm made of silicon material with 5 degrees angulation (because greater wedging is associated with foot discomfort) was used.
Full-length wedge extends under the lesser metatarsal heads which increases the lever arm for rearfoot eversion and thus can prevent subtalar joint rotation.
The evaluations were performed every week till fourth week.
|
|
Aktiver Komparator: Traditional physiotherapy with home exercises group (Group 2)
Each participant received 40-45 minutes long session, started in lying position.
The therapeutic low-intensity pulsed ultrasound (US) was used for 7 minutes with the frequency of 1 MHz, Spatial Average Intensity was 0.2 W /cm2, pulsed duty cycle 20%, therapeutic dose was 112.5 J/cm2 with fixed application on the medial side of the knee joint.
The model of US was Unit Intelect Mobile, (Chattanooga Inc).
After US therapy passive stretching of calf, hamstring, quadriceps, hip flexors, adductors & abductor s was done, which was followed by the manual strengthening exercises and strengthening with quadriceps bench.
The session was repeated thrice a week and 12 sessions per month.
The home program was guided in both groups including avoiding low sitting, cross leg sitting along with Isometrics of quadriceps atleast 3 times a day, with 5-10 seconds hold of each contraction.
|
Each participant received 40-45 minutes long session, started in lying position.
The therapeutic low-intensity pulsed ultrasound (US) was used for 7 minutes with the frequency of 1 MHz, Spatial Average Intensity was 0.2 W /cm2, pulsed duty cycle 20%, therapeutic dose was 112.5 J/cm2 with fixed application on the medial side of the knee joint.
The model of US was Unit Intelect Mobile, (Chattanooga Inc).
After US therapy passive stretching of calf, hamstring, quadriceps, hip flexors, adductors & abductor s was done, which was followed by the manual strengthening exercises and strengthening with quadriceps bench.
The session was repeated thrice a week and 12 sessions per month.
The home program was guided in both groups including avoiding low sitting, cross leg sitting along with Isometrics of quadriceps atleast 3 times a day, with 5-10 seconds hold of each contraction.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Knee injury and osteoarthritis outcome pain score
Zeitfenster: Upto 4 weeks
|
Pain associated with daily tasks is measured through Knee injury and osteoarthritis outcome pain score with categories as 'None' for no pain and 'Extreme' for maximum pain value.
|
Upto 4 weeks
|
|
Knee injury and osteoarthritis outcome stiffness score
Zeitfenster: Upto 4 weeks
|
It is measured through Knee injury and osteoarthritis outcome stiffness score with categories as 'None' for no stiffness and 'Extreme' for maximum stiffness.
|
Upto 4 weeks
|
|
Knee injury and osteoarthritis outcome functional status score
Zeitfenster: Upto 4 weeks
|
Degree of difficulty in performing daily tasks associated with knee joint is measured through Knee injury and osteoarthritis outcome functional status score with categories as 'None' for no difficulty in tasks and 'Extreme' for maximum difficulty in performing tasks. .
|
Upto 4 weeks
|
|
Knee injury and osteoarthritis outcome quality of life score
Zeitfenster: Upto 4 weeks
|
Quality of life regarding knee joint disease is measured through Knee injury and osteoarthritis outcome quality of life score with categories as according to patient's satisfaction.
|
Upto 4 weeks
|
Mitarbeiter und Ermittler
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Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
15. September 2020
Primärer Abschluss (Tatsächlich)
20. Juni 2021
Studienabschluss (Tatsächlich)
20. Juni 2021
Studienanmeldedaten
Zuerst eingereicht
26. Oktober 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
26. Oktober 2021
Zuerst gepostet (Tatsächlich)
2. November 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
2. November 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
26. Oktober 2021
Zuletzt verifiziert
1. Oktober 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- BIHS-RABBIYA/Lecturer DPT
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Ja
Art der unterstützenden IPD-Freigabeinformationen
- Studienprotokoll
- Statistischer Analyseplan (SAP)
- Einwilligungserklärung (ICF)
- Klinischer Studienbericht (CSR)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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