An interventional study of Lateral wedge insoles with home exercises group(Group 1) and Traditional physiotherapy with home exercises group (Group 2) in Medial Compartment Knee Osteoarthritis, sponsored by Isra University. Completed at 1 site in Pakistan. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-11-02.
Sponsored by Isra University · Not applicable, Interventional, and Treatment
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).
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).
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 40 is below the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Isra University is the lead sponsor of 27 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Other: Lateral wedge insoles with home exercises group(Group 1)
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.
Other: Traditional physiotherapy with home exercises group (Group 2)
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.
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.
Knee injury and osteoarthritis outcome pain score
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.
Time frame: Upto 4 weeks
Knee injury and osteoarthritis outcome stiffness score
It is measured through Knee injury and osteoarthritis outcome stiffness score with categories as 'None' for no stiffness and 'Extreme' for maximum stiffness.
Time frame: Upto 4 weeks
Knee injury and osteoarthritis outcome functional status score
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. .
Time frame: Upto 4 weeks
Knee injury and osteoarthritis outcome quality of life score
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.
Time frame: Upto 4 weeks
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
No publications or documents are linked to this record.
Ran from Sep 2020 to primary completion in Jun 2021, 9 months.
Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 9 months is below that.
Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Isra University