Tailored lateral wedge insoles in medial knee osteoarthritis

ISRCTN ISRCTN13577116
DOI https://doi.org/10.1186/ISRCTN13577116
Secondary identifying numbers 1A
Submission date
08/08/2019
Registration date
05/10/2019
Last edited
03/09/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Vitor Ferreira
Scientific

Rua Infante D. Henrique, 4 r/ch dtº trás
Aveiro
3810-377
Portugal

Phone +351 (0)919214831
Email vitorfontesferreira@gmail.com

Study information

Study designSingle-centre randomized control trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleTailored lateral wedge insoles in medial knee osteoarthritis
Study objectivesAn 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(s)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
Health condition(s) or problem(s) studiedMedial knee osteoarthritis
InterventionThe 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 typeOther
Primary outcome measureFirst peak external knee adduction moment measured by gait analysis at baseline and 12 weeks
Secondary outcome measures1. 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 study start date01/05/2017
Completion date31/10/2019

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40
Total final enrolment38
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/05/2018
Date of final enrolment01/08/2019

Locations

Countries of recruitment

  • Portugal

Study participating centre

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

Sponsor information

Faculdade de Desporto da Universidade do Porto
University/education

R. Dr. Plácido da Costa 91
Porto
4200-450
Portugal

Phone +351 (0)22 04 5 200
Email expediente@fade.up.pt
ROR logo "ROR" https://ror.org/043pwc612

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/01/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planThe protocol is not published and/or available online. Planned publication of the results in peer-reviewed journals.
IPD sharing planAll 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 15/03/2021 03/09/2021 Yes No

Editorial Notes

03/09/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
23/09/2019: Trial's existence confirmed by ethics committee.