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
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