Clinical trial of insoles for pain at the front of the knee

ISRCTN	ISRCTN84641129
DOI	https://doi.org/10.1186/ISRCTN84641129
Protocol serial number	CT223
Sponsor	SSL International (UK)
Funder	SSL International (UK)

Submission date: 23/04/2008
Registration date: 31/07/2008
Last edited: 06/05/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Christopher Nester
Scientific

Director
Centre for Rehabilitation & Human Performance Research
Brian Blatchford Building
University of Salford
Salford
M6 6PU
United Kingdom

Phone	+44 (0)161 295 2275
Email	c.j.nester@salford.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised subject-blinded single-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised controlled trial to evaluate the effectiveness of insoles to treat anterior knee (patella femoral) pain
Study acronym	KP Trial
Study objectives	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(s)	Ethics Committee, University of Salford, 12/03/2008, ref: 07/054
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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)
Completion date	31/07/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	28/03/2008
Date of final enrolment	31/07/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Director

Salford
M6 6PU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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