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Effectiveness of Lateral Wedge Insole on Knee Osteoarthritis Outcomes in Pakistani Population

Primary Purpose

Medial Compartment Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Lateral wedge insoles with home exercises group(Group 1)
Traditional physiotherapy with home exercises group (Group 2)
Sponsored by
Isra University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medial Compartment Knee Osteoarthritis focused on measuring Knee osteoarthritis, functional independence, musculoskeletal physiotherapy, orthotics, quality of life.

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rabbiya Riaz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Lateral wedge insoles with home exercises group(Group 1)

Traditional physiotherapy with home exercises group (Group 2)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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. .
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.

Secondary Outcome Measures

Full Information

First Posted
October 26, 2021
Last Updated
October 26, 2021
Sponsor
Isra University
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1. Study Identification

Unique Protocol Identification Number
NCT05104008
Brief Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
June 20, 2021 (Actual)
Study Completion Date
June 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isra University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medial Compartment Knee Osteoarthritis
Keywords
Knee osteoarthritis, functional independence, musculoskeletal physiotherapy, orthotics, quality of life.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lateral wedge insoles with home exercises group(Group 1)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Traditional physiotherapy with home exercises group (Group 2)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Lateral wedge insoles with home exercises group(Group 1)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional physiotherapy with home exercises group (Group 2)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knee injury and osteoarthritis outcome pain score
Description
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
Title
Knee injury and osteoarthritis outcome stiffness score
Description
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
Title
Knee injury and osteoarthritis outcome functional status score
Description
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
Title
Knee injury and osteoarthritis outcome quality of life score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Rabbiya Riaz
City
Islamabad
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Effectiveness of Lateral Wedge Insole on Knee Osteoarthritis Outcomes in Pakistani Population

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