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
Secondary identifying numbers 7883
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

Study designSingle centre randomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe effectiveness of Shoes and Insoles on the Loading at the Knee in subjects with knee osteoarthritis: single centre randomised interventional treatment trial
Study acronymSILK
Study objectivesThe 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) studiedTopic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
InterventionPatients 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 typeOther
Primary outcome measure1. 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 measures1. 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 study start date31/08/2009
Completion date31/08/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned sample size: 50
Key inclusion criteriaTo 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 criteria1. 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 enrolment31/08/2009
Date of final enrolment31/08/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Manchester
Manchester
M13 9PT
United Kingdom

Sponsor information

University of Salford (UK)
University/education

Arthritis Research Campaign
Copeman House
St. Marys Court
St. Marys Gate
Chesterfield
S41 7TD
England
United Kingdom

Website http://www.salford.ac.uk/
ROR logo "ROR" https://ror.org/01tmqtf75

Funders

Funder type

Charity

Arthritic Research Campaign (ARC) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added 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.