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