Effectiveness of Lateral Wedge Insole on Knee Osteoarthritis Outcomes in Pakistani Population
26 ottobre 2021 aggiornato da: 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).
Panoramica dello studio
Stato
Completato
Descrizione dettagliata
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).
Tipo di studio
Interventistico
Iscrizione (Effettivo)
40
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Punjab
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Islamabad, Punjab, Pakistan
- Rabbiya Riaz
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 40 anni a 70 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 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.
|
|
Comparatore attivo: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Knee injury and osteoarthritis outcome pain score
Lasso di tempo: 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.
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Upto 4 weeks
|
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Knee injury and osteoarthritis outcome stiffness score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
15 settembre 2020
Completamento primario (Effettivo)
20 giugno 2021
Completamento dello studio (Effettivo)
20 giugno 2021
Date di iscrizione allo studio
Primo inviato
26 ottobre 2021
Primo inviato che soddisfa i criteri di controllo qualità
26 ottobre 2021
Primo Inserito (Effettivo)
2 novembre 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
2 novembre 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 ottobre 2021
Ultimo verificato
1 ottobre 2021
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BIHS-RABBIYA/Lecturer DPT
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Sì
Tipo di informazioni di supporto alla condivisione IPD
- Protocollo di studio
- Piano di analisi statistica (SAP)
- Modulo di consenso informato (ICF)
- Relazione sullo studio clinico (CSR)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .