Condition category
Musculoskeletal Diseases
Date applied
08/08/2019
Date assigned
05/10/2019
Last edited
23/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Knee osteoarthritis (OA) is a degenerative joint disease with no known cure that is characterized by joint pain and dysfunction. One of the factors for the progress of OA is the increased physical forces causing damage in the joint. Knee malalignment is a key factor for the progress to more severe disease. Traditional treatments have shown poor long-term effectiveness. Biomechanical interventions are advised in order to provide a better alignment and a redistribution of mechanical forces. Lateral wedge insoles are effective on external knee adduction moment reduction. However, some patients do not respond to treatment. The aim of this study is to find out whether tailored lateral wedge insoles worn daily for 12 weeks can improve the symptoms of patients with medial knee OA.

Who can participate?
Patients aged 50 to 80 with medial knee OA

What does the study involve?
Participants are randomly allocated to use either neutral insoles or tailored lateral wedge insoles to put inside their own shoe and use for 3 months. Knee function and pain are assessed at the start of the study and after 3 months.

What are the possible benefits and risks of participating?
Patients may benefit from reduced symptoms such as pain or knee edema. There are no known risks with the use of insoles, only foot discomfort.

Where is the study run from?
University of Porto (Portugal)

When is the study starting and how long is it expected to run for?
May 2017 to October 2019

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Vitor Ferreira
vitorfontesferreira@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vitor Ferreira

ORCID ID

Contact details

Rua Infante D. Henrique
4 r/ch dtº trás
Aveiro
3810-377
Portugal
+351 (0)919214831
vitorfontesferreira@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1A

Study information

Scientific title

Tailored lateral wedge insoles in medial knee osteoarthritis

Acronym

Study hypothesis

An adjusted degree of lateral wedge insoles compared with control insoles worn daily for 12 weeks improve symptoms and biomechanical parameters in people with medial knee OA.

Ethics approval

Approved 24/03/2017, Ethics Committee of the Faculty of Sports of the University of Porto, and Ethics Committee of local hospitals (Faculdade de Desporto da Universidade do Porto, R. Dr. Plácido da Costa 91, 4200-450 Porto, Portugal; Tel: +351 (0)22 04 25 200; Email: cefade@fade.up.pt), Process CEFADE 10.2016

Study design

Single-centre randomized control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Medial knee osteoarthritis

Intervention

The randomization sequence was generated using specific software by an independent collaborator not directly involved in assessment of participants.

Participants in the experimental group received a pair of customized lateral wedge insoles to put inside their own shoe and use for 3 months. The lateral wedge insoles were custom made with a pronating wedge posterior long. The degree of the lateral wedge insole in the experimental group was customized to each participant by the acute effects on initial biomechanical measurements.

The participants of the control group received a pair of neutral lateral wedge insoles.

Intervention type

Other

Phase

Drug names

Primary outcome measure

First peak external knee adduction moment measured by gait analysis at baseline and 12 weeks

Secondary outcome measures

1. Pain measured with visual analog scale at baseline and 12 weeks
2. Pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life, measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire at baseline and 12 weeks
3. Physical function assessed using physical tests (30s chair stand test; 40m fast-paced walk test; stair climb test) at baseline and 12 weeks

Overall trial start date

01/05/2017

Overall trial end date

31/10/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Diagnosis of knee OA made according to the clinic and radiographic criteria established by the American College of Rheumatology. This comprises medial knee pain, radiographic osteophyte in the medial joint space of the knee and morning stiffness lasting ˃30 min and/or crepitus during motion
2. Specific radiographic inclusion criteria are Kellgren & Lawrence grade 2 or 3 on a full-length anteroposterior radiograph
3. Age ˃ 50 and < 80 years old
4. Medial knee pain in the past week of ≥3 on Visual Analog Scale

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Symptomatic evidence of lateral compartment
2. Patellofemoral OA
3. Knee surgery within the past six months
4. Systemic arthritic conditions
5. Corticosteroid injection within the previous six weeks
6. Body mass index above 35 (difficult to accurately place motion capture markers)
7. Any other condition affecting lower limb function

Recruitment start date

01/05/2018

Recruitment end date

01/08/2019

Locations

Countries of recruitment

Portugal

Trial participating centre

University of Porto
Porto Biomechanics Laboratory (LABIOMEP) R. Dr. Plácido da Costa 91
Porto
4200-450
Portugal

Sponsor information

Organisation

Faculdade de Desporto da Universidade do Porto

Sponsor details

R. Dr. Plácido da Costa 91
Porto
4200-450
Portugal
+351 (0)22 04 5 200
expediente@fade.up.pt

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The protocol is not published and/or available online. Planned publication of the results in peer-reviewed journals.

IPD sharing statement
All data collected is confidential. No personal identification will be made in any publication of the results of this study. Group results will be presented later, but the participant will never be individually identified. Data access requests may be made to Vitor Ferreira (v.ferreira@ua.pt), but only group statistics, up to a maximum of 2 years after the end of the study.

Intention to publish date

01/01/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/09/2019: Trial's existence confirmed by ethics committee.