Effectiveness of custom made insoles in athletes with patellofemoral pain; a randomized controlled trial.

Completed

Conditions: anterior knee pain
chondromalacia patellae
10043237

Registration Number: NL-OMON37189

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

- Age 18-40 years
- athletes sporting at least three hours a week pre-injury
- clinical diagnosis of patellofemoral pain syndrome: insidious onset of anterior or retropatellar knee pain lasting longer than six weeks and provoked by at least two of the following activities: prolonged sitting or kneeling, squatting, running, hopping/jumping, climbing stairs; tenderness upon palpation of the patella, and worst pain over the previous week of at least 3 out of 10 on a 10-point numerical rating scale.

Exclusion Criteria

- A traumatic origin
- Concomitant injury or pain form the hip, lumbar spine, or other knee structures (like intra-articular pathology of the knee, Osgood Schlatter*s disease, bursitis and patellar tendinopathy)
- Previous knee surgery
- Patellofemoral instability
- Knee joint effusion
- Previous treatment with insoles or physiotherapy in the preceding 12 months

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>General pain severity over the preceding week after 12 weeks from baseline,<br /><br>measured on a numeric rating scale (NRS).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- experience of pain (using a NRS) and impairment (using a Likert scale) on<br /><br>activities of daily living, on work/study and on sporting activities over the<br /><br>preceding week<br /><br>- self-reported recovery (using a Likert scale)<br /><br>- functional disability (using the Anterior Knee Pain scale)<br /><br>- participants pain experience (using two questionnaires: SCL-90 and POMS)<br /><br>- satisfaction with the custom-made insoles based on comfort</p><br>