Early Intervention for Adolescents With Patellofemoral Pain Syndrome
| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | August 2, 2011 | ||||||||||||||||
| Last Updated Date | September 26, 2011 | ||||||||||||||||
| Start Date ICMJE | June 2011 | ||||||||||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Change in perception of recovery after 12 months measured on a 7-point likert scale ranging from "completely recovered" to "worse than ever". [ Time Frame: Baseline, 3, 6, 12 and 24months ] [ Designated as safety issue: No ] Perception of recovery after 12 months measured on a 7-point likert scale ranging from "completely recovered" to "worse than ever". |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT01438762 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Early Intervention for Adolescents With Patellofemoral Pain Syndrome | ||||||||||||||||
| Official Title ICMJE | Early Intervention for Adolescents With Patellofemoral Pain Syndrome - a Cluster Randomized Trial | ||||||||||||||||
| Brief Summary | Self-reported, unspecific knee pain is highly prevalent among adolescents. A large proportion of the unspecific knee pain can be attributed to Patellofemoral Pain Syndrome (PFPS). There are a number of treatment options for PFPS. Physical therapy has been advocated as one of the cornerstones in rehabilitation of patients with PFPS. Twenty-five years ago, McConnell proposed a multimodal approach that combined several treatment options. The regimen included retraining of the vastus medialis oblique muscle through functional weight bearing activities. This exercise is combined with patellar taping, patellar mobilization, and stretching to improve patellar tracking, reduce pain, and enhance vastus medialis oblique muscle activation. Short term results (<12 months) indicates that multimodal physiotherapy is more effective than placebo treatment. While treatment for PFPS may be successful for the short-term, long-term results are less promising. A recent review covering the long term prognosis for patients diagnosed with PFPS, reported that only 1/3 of those diagnosed with PFPS and treated conservatively were pain free 12 months after diagnosis. Further ¼ stopped participating in sports because of knee pain. Predictors of long term outcome (>52weeks) indicate that a long symptom duration, higher age and greater severity at baseline are associated to poorer outcome after treatment. These prognostic factors suggest that an early initiation of treatment might lead to a better long-term prognosis. The purpose of this study is to examine the short and long-term effectiveness of multi-modal physiotherapy compared to standard wait-and-see treatment applied at a very early state of disease among adolescents. The investigators hypothesized a significantly larger proportion of completely recovered patients at three-month follow-up in the interventions group compared to the control group. |
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| Detailed Description | Not Provided | ||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Patellofemoral Pain Syndrome | ||||||||||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Rathleff MS, Roos EM, Olesen JL, Rasmussen S. Early intervention for adolescents with patellofemoral pain syndrome--a pragmatic cluster randomised controlled trial. BMC Musculoskelet Disord. 2012 Jan 27;13:9. | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||
| Estimated Enrollment ICMJE | 102 | ||||||||||||||||
| Estimated Completion Date | September 2014 | ||||||||||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria:
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| Gender | Both | ||||||||||||||||
| Ages | 15 Years to 19 Years | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT01438762 | ||||||||||||||||
| Other Study ID Numbers ICMJE | N-20110020 | ||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||
| Responsible Party | Michael Skovdal Rathleff, Northern Orthopaedic Division, Denmark | ||||||||||||||||
| Study Sponsor ICMJE | Michael Skovdal Rathleff | ||||||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Northern Orthopaedic Division, Denmark | ||||||||||||||||
| Verification Date | September 2011 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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