The Effect of Infrapatellar Strap Treatment on Pain Extent and Athletic Measures in Young Athletes

July 16, 2015 updated by: Dr. Eyal Shargal, Wingate Institute

The Effect of Infra Patellar Strap Treatment on the Extent of Pain and Performance in Young Athletes With Patellar Tendinopathy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Netanya, Israel, 42902
        • Wingate Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: patella knee strap
infra patella knee strap- cotton, applied in straight leg
Device: patella knee strap
infra patella strap 100% cotton pressure is exerted immediately under the patella
Other Names:
  • FDA regulation number 890.3475

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
level of pain ranked upon visual analog scale by the subject
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 Measures

Outcome Measure
Measure Description
Time Frame
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.
the height of squat jump, drop jump, one leg jump and 30 sec repetitve jumps (mean height) as mesured by the optojump system
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wingate Institute

Investigators

  • Study Director: gali dar, Phd, Wingate Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 5, 2011

First Submitted That Met QC Criteria

October 24, 2011

First Posted (Estimate)

October 26, 2011

Study Record Updates

Last Update Posted (Estimate)

July 17, 2015

Last Update Submitted That Met QC Criteria

July 16, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Winphys01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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