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

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Christopher Nester


Contact details

Centre for Rehabilitation & Human Performance Research
Brian Blatchford Building
University of Salford
M6 6PU
United Kingdom
+44 (0)161 295 2275

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A randomised controlled trial to evaluate the effectiveness of insoles to treat anterior knee (patella femoral) pain


KP Trial

Study hypothesis

Knee pain remains a significant burden to a large proportion of the population. It has a multifactorial etiology and diagnosis is often non specific. Anterior knee pain (patellofemoral pain syndrome) has been described as the most prevalent disorder of the knee. The cause of the condition is not clearly understood and the cause of pain may not be the same for each person. Hence a variety of treatment regimes (devices) are employed for the treatment of the condition. Citizens are likely to seek their own approaches to managing knee pain prior whilst waiting for, or instead of, seeking advice and remedy from the health services. This trial will seek to evaluate the effectiveness of an in shoe type of orthosis in the management of anterior knee pain.

Hypothesis: a functional insole will produce greater improvements in knee pain compared to a sham control group.

Ethics approval

Ethics Committee, University of Salford, 12/03/2008, ref: 07/054

Study design

Randomised subject-blinded single-centre trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Anterior knee pain


The participants will be randomly allocated to the following two arms:
1. Arm 1: Orthaheel® regular. This is a 3/4 length insole with arch shape. It is inserted into shoes and worn daily for 12 months
2. Arm 2: Sham control insole. This is a full length 3 mm deep soft flat insole. It is inserted into shoes and worn daily for 12 months

Intervention type



Not Specified

Drug names

Primary outcome measures

1. Knee pain
2. Knee function

The outcomes above will be measured using the following at 4 weeks:
a. VAS (scores 0-10)
b. The Kujala Anterior knee pain questionnaire

Secondary outcome measures

1. Use of insoles (in time)
2. Knee pain at 3, 6 and 12 months (see primary outcome measures for methods of measurement)
3. Knee function at 3, 6 and 12 months (see primary outcome measures for methods of measurement)

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Male or female participants between the ages of 18 and 65 years old
2. Participants with self-reported anterior knee pain (pain at the front of the knee) with a minimum of 4 weeks duration
3. Participants with self-reported anterior knee pain who score at least 40 mm on a 100 mm visual analogue scale (VAS) for pain
4. Participants with self-reported anterior knee pain in the 2 days prior to recruitment
5. Participants who agree to wear the insoles provided for at least 4 hours each day and complete diary cards and postal questionnaire as required
6. Participants who give written informed consent

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Patients must not report any acute injury to the knee at the onset of their anterior knee pain
2. Patients must not report posterior or medial/lateral knee pain or any secondary pain elsewhere in lower limb joints since the onset of anterior knee pain
3. Patients must not have any significant diagnosed musculo-skeletal disease, such as rheumatoid arthritis, diabetes or osteoarthritis of the knee or deterioration dysfunction of associated structures of the knee e.g., cartilage or any other condition associated with sensory and motor dysfunction
4. Patients must not have received or self administered treatment for the knee pain in the previous 4 weeks
5. Patients who are pregnant or breast-feeding
6. Patients who have received or self-administered treatment for the knee pain in the previous 4 weeks
7. Patients who have received corticosteroid injection therapy in the knee in the previous 3 months
8. Patients that were previously in this study
9. Patients that were in another study within the last 3 months

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

M6 6PU
United Kingdom

Sponsor information


SSL International (UK)

Sponsor details

SSL International Plc
Venus Building
1 Old Park Lane
M41 7HA
United Kingdom

Sponsor type




Funder type


Funder name

SSL International (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

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

06/05/2016: No publications found, verifying study status with principal investigator.