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van CCT (UK)

van CCT (UK)

Effectiveness of insoles in athletes with patellofemoral pain.

- candidate number12373
- NTR NumberNTR3430
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-mei-2012
- Secondary IDs 
- Public TitleEffectiveness of insoles in athletes with patellofemoral pain.
- Scientific TitleEffectiveness of custom made insoles in athletes with patellofemoral pain: A randomized controlled trial.
- hypothesisOur hypothesis is that custom made insoles and a home-based exercise program would be superior to a home-based exercise program alone at 12 weeks follow-up.
- Healt Condition(s) or Problem(s) studiedPatellofemoral pain syndrom, Insoles, Athletes
- Inclusion criteria1. Age 18-40 years;
2. Athlete sporting at least 3 hours a week pre-injury;
3. Clinical diagnosis of patellofemoral pain syndrome: insidious onset of anterior or retropatellar knee pain of greater than six weeks duration and provoked by at least two of the following activities: prolonged sitting or kneeling, squatting, running, hopping/jumping, or stair walking;
4. Tenderness on palpation of the patella, or pain with step down or double leg squat;
5. Worst pain over de previous week of at least 3 out of 10 on a 10 point numerical rating scale.
- Exclusion criteria1. A traumatic origin;
2. Concomitant injury or pain form the hip, lumbar spine, or other knee structures;
3. Previous knee surgery;
4. Patellofemoral instability;
5. Knee joint effusion;
6. Any foot condition that precluded use of insoles;
7. Previous treatment with insoles or physiotherapy in the preceding 12 months.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2012
- planned closingdate1-dec-2013
- Target number of participants70
- InterventionsThe patiŽnt will be randomly assigned to the treatment or placebo group. Both the treatment and the placebo group will receive a home exercise program. In addition the treatment group receives custom made insoles and the placebo group flat insoles. They will have to wear the custom made insoles daily.
- Primary outcomeThe participants fill in a (online) questionnaire before randomisation (baseline) and at 6 and 12 weeks after randomisation. The questionnaires contain questions regarding general pain and impairment, pain and impairment on general activities of daily living, during work/study activities and during sporting activities over the preceding week (10 point Likert scale), self reported recovery (6 point Likert scale) and the Kujala score.
- Secondary outcomeN/A
- TimepointsStart inclusion: August 2012;
Start intervention: September 2012;
Follow-up: September 2012 till december 2012/ Februari 2013;
End of study: December 2013.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
Center for Sports medicine UMCG
- PublicationsN/A
- Brief summaryThis study had been designed after reviewing the literature on conservative therapy for patellofemoral pain syndrome in athletes. It was concluded despite the prevalence and the impact of PFPS is huge there is a lack of high quality research on the conservative management of PFPS in athletes. Insoles seem tot play an important role in the prevention and clinical management of PFPS in the general, but again this is not studied in athletes. Based on available literature our research group expects to discover effectiveness of insoles in athletes with patellofemoral pain in perceived recovery, pain severity, impairment and functional disability. This study is a randomized clinical trial where customised insoles and a home based exercise program is compared to flat insoles and a home based exercise program.
- Main changes (audit trail)
- RECORD13-mei-2012 - 10-jun-2012

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