NCT03225911

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)

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 25, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2019

Completed
Last Updated

July 24, 2017

Status Verified

July 1, 2017

Enrollment Period

1.2 years

First QC Date

July 19, 2017

Last Update Submit

July 20, 2017

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (4)

  • External knee adduction moment (EKAM)

    External knee adduction moment is a curve which is consider as indirect measurement of the knee loading. Using the gait analysis system will give us this outcome

    6 weeks

  • Pain measurment.

    10 cm visual analogue scale will be used to measure pain.

    6 weeks

  • Muscle co-contraction

    Muscle co-contraction can be measured after using Electromyography machine. This outcome gives us indicator to the effect of the treatment on muscle activity and loading.

    6 weeks

  • Dynamic balance

    The modified star excursion balance test will be used. In this test, the participants balance on maintaining single-leg stance, while reaching with the free limb in anterior and lateral directions in relation to the stance foot as far as they can, then return to double support without losing balance.

    6 weeks

Secondary Outcomes (4)

  • Joint position sense

    6 weeks

  • Pressure pain threshold

    6 weeks

  • Physical function tests

    6 weeks

  • Physical activity level

    6 weeks

Study Arms (3)

Insole group

EXPERIMENTAL

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.

Device: Lateral wedge insole (insole)

Sleeve group

EXPERIMENTAL

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.

Device: simple knee sleeve (sleeve)

insole + sleeve group

EXPERIMENTAL

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.

Device: simple knee sleeve + lateral wedge insole

Interventions

Lateral wedge insole (insole)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.

Insole group
simple knee sleeve (sleeve)DEVICE

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

Also known as: knee support
Sleeve group
simple knee sleeve + lateral wedge insoleDEVICE

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.

insole + sleeve group

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Richard K jones, Phd

    Salford University

    STUDY DIRECTOR

Central Study Contacts

Omar Althomali, PhD student

CONTACT

07427164565tt7uu@hotmail.com

Richard K jones, Phd

CONTACT

0161060549r.k.jones@salford.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Omar Althomali, PhD student, Principal Investigator, University of Salford

Study Record Dates

First Submitted

July 19, 2017

First Posted

July 21, 2017

Study Start

September 25, 2017

Primary Completion

December 25, 2018

Study Completion

March 25, 2019

Last Updated

July 24, 2017

Record last verified: 2017-07