The Effect of Infrapatellar Strap Treatment on Pain Extent and Athletic Measures in Young Athletes
Primary Purpose
Patellar Tendonitis, Jumper's Knee, Patellar Tendinopathy
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
patella knee strap
Sponsored by
About this trial
This is an interventional supportive care trial for Patellar Tendonitis focused on measuring patellar tendinopathy, jumper's knee
Eligibility Criteria
Inclusion Criteria:
- elite male athlete
- basketball and volleyball player
- ages 14-18
- clinical diagnosis of patellar tendinopathy
- able to jump
Exclusion Criteria:
- undergo a surgical procedure in knee
Sites / Locations
- Wingate Institute
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
patella knee strap
Arm Description
infra patella knee strap- cotton, applied in straight leg
Outcomes
Primary Outcome Measures
change in pain level after applying an infra patellar strap
level of pain ranked upon visual analog scale by the subject
Secondary Outcome Measures
change in height of jump after applying an infra patellar strap
the height of squat jump, drop jump, one leg jump and 30 sec repetitve jumps (mean height) as mesured by the optojump system
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01460004
Brief Title
The Effect of Infrapatellar Strap Treatment on Pain Extent and Athletic Measures in Young Athletes
Official Title
The Effect of Infra Patellar Strap Treatment on the Extent of Pain and Performance in Young Athletes With Patellar Tendinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wingate Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is:
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.
40 elite male athletes, basketball and volleyball players, ages 14-18, students of the academy for sports Excellency will take part in this study
Hypothesis 1: The treatment of infra patellar strap will reduce the level of pain during jumping performance tasks.
Hypothesis 2: The treatment of infra patellar strap will improve the squat jump height in athletes with patellar tendinopathy during squat jump task.
Hypothesis 3: The treatment of infra patellar strap will improve the drop jump height in athletes with patellar tendinopathy during drop jump task.
Hypothesis 4: The treatment of infra patellar strap will improve the one leg jump height in athletes with patellar tendinopathy during one leg jump task.
Hypothesis 5: The treatment of infra patellar strap will improve the 30 seconds repetitive jumps mean height in athletes with patellar tendinopathy during 30 seconds repetitive jumps task.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Tendonitis, Jumper's Knee, Patellar Tendinopathy
Keywords
patellar tendinopathy, jumper's knee
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patella knee strap
Arm Type
No Intervention
Arm Description
infra patella knee strap- cotton, applied in straight leg
Intervention Type
Device
Intervention Name(s)
patella knee strap
Other Intervention Name(s)
FDA regulation number 890.3475
Intervention Description
infra patella strap 100% cotton pressure is exerted immediately under the patella
Primary Outcome Measure Information:
Title
change in pain level after applying an infra patellar strap
Description
level of pain ranked upon visual analog scale by the subject
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.
Secondary Outcome Measure Information:
Title
change in height of jump after applying an infra patellar strap
Description
the height of squat jump, drop jump, one leg jump and 30 sec repetitve jumps (mean height) as mesured by the optojump system
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.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
elite male athlete
basketball and volleyball player
ages 14-18
clinical diagnosis of patellar tendinopathy
able to jump
Exclusion Criteria:
undergo a surgical procedure in knee
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
gali dar, Phd
Organizational Affiliation
Wingate Institute
Official's Role
Study Director
Facility Information:
Facility Name
Wingate Institute
City
Netanya
ZIP/Postal Code
42902
Country
Israel
12. IPD Sharing Statement
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The Effect of Infrapatellar Strap Treatment on Pain Extent and Athletic Measures in Young Athletes
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