Condition category
Musculoskeletal Diseases
Date applied
23/04/2008
Date assigned
31/07/2008
Last edited
06/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christopher Nester

ORCID ID

Contact details

Director
Centre for Rehabilitation & Human Performance Research
Brian Blatchford Building
University of Salford
Salford
M6 6PU
United Kingdom
+44 (0)161 295 2275
c.j.nester@salford.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CT223

Study information

Scientific title

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

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Anterior knee pain

Intervention

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

Other

Phase

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

28/03/2008

Overall trial end date

31/07/2009

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

100

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

28/03/2008

Recruitment end date

31/07/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Director
Salford
M6 6PU
United Kingdom

Sponsor information

Organisation

SSL International (UK)

Sponsor details

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

Sponsor type

Industry

Website

http://www.ssl-international.com

Funders

Funder type

Industry

Funder name

SSL International (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

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.