Clinical trial NCT05104008: Effectiveness of Lateral Wedge Insole on Knee Osteoarthritis Outcomes in Pakistani Population
Official title: Effectiveness of Lateral Wedge Insole on Knee Osteoarthritis Outcomes in Pakistani Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medial Compartment Knee Osteoarthritis
Keywords: Knee osteoarthritis, functional independence, musculoskeletal physiotherapy, orthotics, quality of life.
Lead sponsor: Isra University
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Knee injury and osteoarthritis outcome pain score
timeFrame: Upto 4 weeks
measure: Knee injury and osteoarthritis outcome stiffness score
timeFrame: Upto 4 weeks
measure: Knee injury and osteoarthritis outcome functional status score
timeFrame: Upto 4 weeks
measure: Knee injury and osteoarthritis outcome quality of life score
timeFrame: Upto 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Rabbiya Riaz
state: Punjab
Study officials:
References: