Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mrs Fiona Stirling


Contact details

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

Additional identifiers

EudraCT number number

Protocol/serial number


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



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal


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



Not Applicable

Drug names

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Manchester
M13 9PT
United Kingdom

Sponsor information


University of Salford (UK)

Sponsor details

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

Sponsor type




Funder type


Funder name

Arthritic Research Campaign (ARC) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Available on request

Basic results (scientific)

Publication list

2013 results in
2014 results in
2015 results in
2015 results in

Publication citations

Additional files

Editorial Notes

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