Effect of a Lateral Wedge Insole and Simple Knee Sleeve in Individuals With Knee Osteoarthritis

NCT ID: NCT03225911

Last Updated: 2017-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-25
• Study Completion Date: 2019-03-25

Brief Summary

The focus of this project is to determine the immediate efficacy of a combined treatment (lateral wedge insole + simple knee sleeve) in individuals with knee osteoarthritis (OA) and the short term effect over 6 weeks. Secondly, to compare the effect of this combined treatment with each treatment on its own (lateral wedge insole, simple knee sleeve)

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Insole group

This group will be treated via using lateral wedge insole. lateral wedge insole is an insole with higher lateral side than medial side. This insole is inserted in the participant shoes.

Group Type: EXPERIMENTAL

Lateral wedge insole (insole)

Intervention Type: DEVICE

The lateral wedge insole is an orthotic device that is placed inside the shoe. It has different thicknesses, with the lateral side being thicker than the medial side. This difference in thickness leads to the lateral side being higher than the medial side, with a different angulation.

Sleeve group

This group will be treated via using simple knee sleeve. Simple knee sleeve is a knee support which has no metal support. This sleeve is wrapped around each participant knee.

Group Type: EXPERIMENTAL

simple knee sleeve (sleeve)

Intervention Type: DEVICE

The simple knee sleeve is support which is worn around the knee with no hinge or provide external valgus moment.

insole + sleeve group

this group will have treated via using the later wedge insole and the sleeve together as combined treatment. lateral wedge insole is an insole with higher lateral side than medial side. This insole is inserted in the participant shoes. Simple knee sleeve is a knee support which has no metal support. This sleeve is wrapped around each participant knee.

Group Type: EXPERIMENTAL

simple knee sleeve + lateral wedge insole

Intervention Type: DEVICE

The lateral wedge insole is an orthotic device that is placed inside the shoe. It has different thicknesses, with the lateral side being thicker than the medial side. This difference in thickness leads to the lateral side being higher than the medial side, with a different angulation. The simple knee sleeve is support which is worn around the knee with no hinge or provide external valgus moment.

Interventions

Lateral wedge insole (insole)

The lateral wedge insole is an orthotic device that is placed inside the shoe. It has different thicknesses, with the lateral side being thicker than the medial side. This difference in thickness leads to the lateral side being higher than the medial side, with a different angulation.

Intervention Type: DEVICE

simple knee sleeve (sleeve)

The simple knee sleeve is support which is worn around the knee with no hinge or provide external valgus moment.

Intervention Type: DEVICE

simple knee sleeve + lateral wedge insole

The lateral wedge insole is an orthotic device that is placed inside the shoe. It has different thicknesses, with the lateral side being thicker than the medial side. This difference in thickness leads to the lateral side being higher than the medial side, with a different angulation. The simple knee sleeve is support which is worn around the knee with no hinge or provide external valgus moment.

Intervention Type: DEVICE

Other Intervention Names

knee support

Eligibility Criteria

Inclusion Criteria

• 1- Mild knee pain during walking on flat surface diagnosis via KOOS questionnaire (3 out of 10) because our aim of the study to reduce pain with combined treatment and pain lower than 3 out of 10 score might not allow to compared the pain reduction between the group.

2- Definitive medial joint narrowing higher or equal to the lateral side and osteophytes on X-Ray A-P or PA view in weight bearing position if possible.

3- Medial joint tenderness either by patient's indication or the clinician under the clinical examination indicating tenderness in the tibiofemoral joint.

4- K-L grade 2 or 3 of plain radiographs. If the patient has had arthroscopy or MRI as their usual clinical care. Indication of grade 1 osteoarthritis pulse the radiological plain x-ray will be used.

5- Being able to walk without assisted devices for 100 meters non-stop because he or she will not be able to complete this study protocol.

Exclusion Criteria

• 1- More pain localized to patellpfemoral or lateral joint than the medial knee side on examination.

2- Tricompartmental knee osteoarthritis. 3- K-L grade 4 or higher. 4- Neurological or orthopaedic situations known to affect the ability to walk. 5- Tibial osteotomy or any other realignment operation. 6- Total knee replacement. 7- Any condition contraindicates orthosiss (sleeve or insole) use. 8- Steroid injection to affected intra-articular knee joint space in the previous month.

9- Previous or current use of any oththosis. 10- Participants with 30 BMI and higher will be excluded because previous study showed that individuals with 33 BMI.

11- Lower than 35 years and higher than 85 as this period was identified to highest incidence period (Losina et al., 2013). Although individuals with 86 and higher has high prevalence to the knee OA, exclusion this population was important due to high amount of walking and balance test.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northern Care Alliance NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University of Salford

OTHER

Sponsor Role: lead

Responsible Party

Omar waslallah althomali

Omar Althomali, PhD student, Principal Investigator, University of Salford

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard K jones, Phd

Role: STUDY_DIRECTOR

Salford University

Central Contacts

Omar Althomali, PhD student

Role: CONTACT

tt7uu@hotmail.com

07427164565

Richard K jones, Phd

Role: CONTACT

r.k.jones@salford.ac.uk

0161060549

Other Identifiers

12345678

Identifier Type: -

Identifier Source: org_study_id