Our 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.
ID
Bron
Aandoening
- Patellofemoral pain syndrom
- Insoles, inlays, orthoses
- Athletes
- Patellofemoraal pijn syndroom
- PFPS
- Inlegzolen
- Sporters
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The 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.
Achtergrond van het onderzoek
This 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.
Doel van het onderzoek
Our 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.
Onderzoeksopzet
Start inclusion: August 2012;
Start intervention: September 2012;
Follow-up: September 2012 till december 2012/ Februari 2013;
End of study: December 2013.
Onderzoeksproduct en/of interventie
The patiënt 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.
Algemeen / deelnemers
Feikje Riedstra
Groningen 9700 RB
The Netherlands
+31 (0)50 3617700
f.riedstra@sport.umcg.nl
Wetenschappers
Feikje Riedstra
Groningen 9700 RB
The Netherlands
+31 (0)50 3617700
f.riedstra@sport.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3277 |
| NTR-old | NTR3430 |
| Ander register | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |