Tailored lateral wedge insoles in medial knee osteoarthritis
| ISRCTN | ISRCTN13577116 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13577116 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 1A |
| Sponsor | Faculdade de Desporto da Universidade do Porto |
| Funder | Investigator initiated and funded |
- 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
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
Scientific
Rua Infante D. Henrique, 4 r/ch dtº trás
Aveiro
3810-377
Portugal
| Phone | +351 (0)919214831 |
|---|---|
| vitorfontesferreira@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomized control trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Tailored lateral wedge insoles in medial knee osteoarthritis |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
First peak external knee adduction moment measured by gait analysis at baseline and 12 weeks |
| Key secondary outcome measure(s) |
1. Pain measured with visual analog scale at baseline and 12 weeks |
| Completion date | 31/10/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 38 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2018 |
| Date of final enrolment | 01/08/2019 |
Locations
Countries of recruitment
- Portugal
Study participating centre
R. Dr. Plácido da Costa 91
Porto
4200-450
Portugal
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | 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. |
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.
