The effectiveness of shoes and insoles on the loading at the knee in subjects with knee osteoarthritis

ISRCTN	ISRCTN83706683
DOI	https://doi.org/10.1186/ISRCTN83706683
Protocol serial number	7883
Sponsor	University of Salford (UK)
Funder	Arthritic Research Campaign (ARC) (UK)

Submission date: 28/05/2010
Registration date: 28/05/2010
Last edited: 21/09/2016

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

Not provided at time of registration

Contact information

Mrs Fiona Stirling
Scientific

University of Manchester
ARC Epidemiology Unit
Stopford Building
Oxford Road
Manchester
M13 9PT
United Kingdom

Study information

Primary study design	Interventional
Study design	Single centre randomised interventional treatment trial
Secondary study design	Randomised controlled trial
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
Study acronym	SILK
Study objectives	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(s)	Tameside (now Northwest 8) MREC, 18/08/2010, ref: 09/H103/51
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/08/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	50
Key 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
Key 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
Date of first enrolment	31/08/2009
Date of final enrolment	31/08/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Manchester

Manchester
M13 9PT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/03/2013	Yes	No
Results article	results	01/09/2014	Yes	No
Results article	results	01/08/2015	Yes	No
Results article	results	01/11/2015	Yes	No

Editorial Notes

21/09/2016: Publication references added.
13/09/2016: No publications found in PubMed, verifying study status with principal investigator.