Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7883
Study information
Scientific title
The effectiveness of Shoes and Insoles on the Loading at the Knee in subjects with knee osteoarthritis: single centre randomised interventional treatment trial
Acronym
SILK
Study hypothesis
The aim of this study is to investigate the role of different shoes and insoles in the treatment of medial tibiofemoral osteoarthritis of the knee joint.
Ethics approval
Tameside (now Northwest 8) MREC, 18/08/2010, ref: 09/H103/51
Study design
Single centre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
Intervention
Patients attend the gait laboratory for one visit that lasts approximately 2-3 hours when they complete the questionnaires and the following gait lab assessments are undertaken, there is no followup.
1. Static Pedography
2. Dynamic Walking
3. Photographs
4. 3-D image obtained
All participants are then treated with different therapeutic insoles/shoes reported to lower the adduction moment. The order in which each participant receives each treatment is randomised prior to the visit.
The interventions are:
1. Barefoot walking
2. Mobility shoe designed to mimic barefoot walking
3. Control shoe on its own
4. Control shoe with unsupported lateral wedge
5. Control shoe with salford wedge
While undertaking each intervention walking is assessed and pain and comfort scores are completed.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. The external knee adduction moment change during the trials will be recorded for all conditions to allow the investigators to determine which intervention has the best reduction in this measure. All sections of the knee adduction moment curve (different peaks) and also the knee adduction angular impulse (the area under the curve) will be assessed for differences between conditions.
2. Patient-perceived global change in pain:
The patient-perceived global change in pain scores during the trials will be analysed on a 5 point likert scale with scores of 1 - much worse, 2 - slightly worse, 3 - No change, 4 - slightly better and 5 - much better (Hinman et al, 2008).
3. Comfort rating questionnaire:
The differences in the overall comfort (Mundermann et al, 2002) of the footwear and the likelihood of using the intervention will be assessed in the different conditions. This is important as it will inform whether the intervention would be generalisable to the whole population and ensure compliance in future studies.
Secondary outcome measures
1. Foot characteristics:
Each of the participants will be given a rating of their foot posture to allow subsequent correlation with the changes seen in the knee adduction moment data.
2. Foot pressure pattern:
The movement of the centre of pressure will be examined to examine each of the interventions characteristics in this pattern. In addition, the foot pressure pattern with be split into seven masks which represent different areas of the foot to examine the peak pressures during the tests.
Overall trial start date
31/08/2009
Overall trial end date
31/08/2010
Reason abandoned
Eligibility
Participant inclusion criteria
To define medial knee OA, a patient must meet all of the following:
1. Pain with walking (using Knee injury and Osteoarthritis Outcome Score [KOOS] pain question, they need to have at least mild pain walking on a flat surface) - clinical diagnosis by qualified clinician
2. On anteroposterior (AP) or posteroanterior (PA) view x-ray (weight bearing, if possible), they need to have definite medial narrowing and NOT lateral narrowing and evidence (osteophyte+ or definite sclerosis) of OA - radiographic diagnosis. Confirmation of radiological diagnosis will be performed by Dr Charles Hutchinson to ensure consistency in x-ray classification less than grade 4 of the Kellgren Lawrence (KL) scale.
3. Medial tenderness either by their own indication that this is where they have pain or by examination showing tenderness at the medial TF joint line - clinical diagnosis by qualified clinician
4. They are able to walk for 100 metres nonstop - participant response
5. Aged 45 years or older, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 50
Participant exclusion criteria
1. Pain is more localised to the patellofemoral joint on examination, rather than medial joint line
2. Have tricompartmental knee osteoarthritis or grade 4 medial tibiofemoral osteoarthritis on the Kellgren Lawrence scale
3. A history of high tibial osteotomy or other realignment surgery
4. Total knee replacement on the affected side
5. Any foot and ankle problems that will contraindicate the use of the footwear load
Recruitment start date
31/08/2009
Recruitment end date
31/08/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Manchester
Manchester
M13 9PT
United Kingdom
Sponsor information
Organisation
University of Salford (UK)
Sponsor details
Arthritis Research Campaign
Copeman House
St. Marys Court
St. Marys Gate
Chesterfield
S41 7TD
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Arthritic Research Campaign (ARC) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Available on request
Results - basic reporting
Publication summary
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23322462
2014 results in http://www.ncbi.nlm.nih.gov/pubmed/24903067
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/25749010
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/25991385