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

NCT05104008 | Completed DMC

• 1 other identifier: BIHS-RABBIYA/Lecturer DPT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Medial Compartment Knee Osteoarthritis

Keywords

Knee osteoarthritis, functional independence, musculoskeletal physiotherapy, orthotics, quality of life.

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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. .

  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.

  Upto 4 weeks

Study Arms (2)

Lateral wedge insoles with home exercises group(Group 1)

ACTIVE COMPARATOR

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)

Traditional physiotherapy with home exercises group (Group 2)

ACTIVE COMPARATOR

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)

Interventions

Lateral wedge insoles with home exercises group(Group 1) OTHER

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.

Lateral wedge insoles with home exercises group(Group 1)

Traditional physiotherapy with home exercises group (Group 2) OTHER

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.

Traditional physiotherapy with home exercises group (Group 2)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with the age criteria of 40-70 years, and who had a history of knee OA were included in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Isra University: lead

Study Sites (1)

Rabbiya Riaz

Islamabad, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 2, 2021
• Study Start: September 15, 2020
• Primary Completion: June 20, 2021
• Study Completion: June 20, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

PA (1)