The Effect of Infrapatellar Strap Treatment on Pain Extent and Athletic Measures in Young Athletes
| Tracking Information | |||||
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| First Received Date ICMJE | October 5, 2011 | ||||
| Last Updated Date | October 24, 2011 | ||||
| Start Date ICMJE | January 2012 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
change in pain level after applying an infra patellar strap [ Time Frame: Within a week from primary physical therapist examination and including in the study. Measures will be taken Before, during and after jump tasks with and without the infra patelar strap, during one session. ] [ Designated as safety issue: No ] level of pain ranked upon visual analog scale by the subject |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01460004 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
change in height of jump after applying an infra patellar strap [ Time Frame: Within a week from primary physical therapist examination and including in the study. while performing the jumps tasks with and without the infra patellar strap. All measures will be collected during one session, without follow-up. ] [ Designated as safety issue: No ] the height of squat jump, drop jump, one leg jump and 30 sec repetitve jumps (mean height) as mesured by the optojump system |
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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 | The Effect of Infrapatellar Strap Treatment on Pain Extent and Athletic Measures in Young Athletes | ||||
| Official Title ICMJE | The Effect of Infra Patellar Strap Treatment on the Extent of Pain and Performance in Young Athletes With Patellar Tendinopathy | ||||
| Brief Summary | The purpose of this study is:
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| Detailed Description | Introduction: Patellar tendinopathy (Jumper's knee) is a condition usually characterized by localized pain and tenderness of the patellar tendon at its origin on the inferior pole of the patella. Patellar tendinopathy is an over use injury which implies on a mismatch between stress on a given tissue and the ability of that tissue to withstand the stress. Rapid repetitive actions of acceleration, deceleration, jumping and landing place great stress on the extensor mechanism and the patellar tendon. Current prevalence reported of patellar tendinopathy is up to 20% among elite athletes from a range of sports, with higher proportions in professional basketball (32%) and volleyball (45%) players. The common treatment for patellar tendinopathy is preventative or conservative (physical therapy). Infra patellar straps are used in treatment to reduce anterior knee pain from a variety of sources including patellar tendinopathy, patellar subluxation, patellar femoral syndrome, Osgood-Schlatter disease and more. In spite of the frequent use of this strap in young athletes and the subjective report of decreased anterior knee pain experienced by the athletes using them, the mechanisms for reducing anterior knee pain has not been explained. In addition, there is no data on the straps effect regarding the extent of pain and functional performance as jumping in this population. The purpose of this study: To examine the effect of infra patellar strap treatment on the extent of pain and jumping performance tasks in young male athletes diagnosed with patellar tendinopathy. Methods: 20 elite male athletes, basketball and volleyball players, ages 14-18, students of the academy for sports Excellency will take part in this study. Athletes approaching the physical therapy department of the Ribstein Center for Sport Medicine Sciences and Research at Wingate Institute, with anterior knee pain, will be examined by a professional physical therapist. The ones who are diagnosed with chronic patellar tendinopathy will be included in the study. Each athlete will attend one meeting in which he will perform four tests: Squat jump test, Drop jump test, one leg jump test and jumps 30 seconds test. The tests with and without the infra patellar strap will be performed using The Optojump measuring system (Microgate, Bolzano, Italy). In addition the athlete will grade his pain severity with and without the infra patellar strap, using The Visual Analog Scale (VAS).There will be no follow up, all the data will be collected in one session. Data will be collected between january 2012 and december 2012, data analysis and summary of the study will be finished at december 2013. Statistical Analysis: In order to examine the difference between the tests results with and without the infra patellar strap, dependent t- test will be performed. Significant level will be set at P<0.05. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE |
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| Intervention ICMJE | Device: patella knee strap
infra patella strap 100% cotton pressure is exerted immediately under the patella
Other Names:
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| Study Arm (s) | No Intervention: patella knee strap
infra patella knee strap- cotton, applied in straight leg
Intervention: Device: patella knee strap |
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| Publications * | Not Provided | ||||
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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 | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | January 2013 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 14 Years to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01460004 | ||||
| Other Study ID Numbers ICMJE | Winphys01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Eyal Shargal, Wingate Institute | ||||
| Study Sponsor ICMJE | Wingate Institute | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Wingate Institute | ||||
| Verification Date | October 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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