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| Tracking Information | |||||
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| First Received Date ICMJE | November 27, 2006 | ||||
| Last Updated Date | May 21, 2008 | ||||
| Start Date ICMJE | March 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE |
VISA-p score [ Time Frame: half year ] | ||||
| Change History | Complete list of historical versions of study NCT00404469 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE |
Tendon Biomechanics [ Time Frame: 12 weeks ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Peritendinous Corticosteroid Injections, Eccentric Training and Heavy Slow Resistance Training in Patellar Tendinopathy | ||||
| Official Title ICMJE | Effects of Peritendinous Corticosteroid Injections, Eccentric Training and Heavy Slow Resistance Training in Patellar Tendinopathy | ||||
| Brief Summary | We will investigate the effect of peritendinous corticosteroid injections, eccentric training and heavy resistance training in male patellar tendinopathy patients. The purpose is to compare the clinical effect of these three treatments in a randomised controlled trial. Also we wish to investigate the treatment mechanisms responsible for the effectiveness of the three treatments. |
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| Detailed Description | 3 interventions groups as described above (n=13 in each group) 12 weeks intervention period. Clinical assessments before and after intervention: VAS, VISA, Tendon thickness, Doppler us activity. Before and after intervention tendon biopsies will be taken and analyzed for crosslinks and fibril diameter. Also tendon mechanical properties will be measured. Tendon and muscle structural properties will be measured with MRI. Treatment satisfaction will be stated after intervention period. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Basic Science, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment | ||||
| Condition ICMJE | Patellar Tendinopathy / Jumpers Knee | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 39 | ||||
| Completion Date | November 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00404469 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | Patellar tendinopathy | ||||
| Study Sponsor ICMJE | Bispebjerg Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Bispebjerg Hospital | ||||
| Verification Date | May 2008 | ||||
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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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