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

This study is currently recruiting participants.
Verified December 2013 by Wingate Institute
Sponsor:
Information provided by (Responsible Party):
Dr. Eyal Shargal, Wingate Institute
ClinicalTrials.gov Identifier:
NCT01460004
First received: October 5, 2011
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

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.

Condition Intervention
Patellar Tendonitis
Jumper's Knee
Patellar Tendinopathy
Device: patella knee strap

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Effect of Infra Patellar Strap Treatment on the Extent of Pain and Performance in Young Athletes With Patellar Tendinopathy

Resource links provided by NLM:


Further study details as provided by Wingate Institute:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • patella knee strap
  • FDA regulation number 890.3475

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.

  Eligibility

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460004

Locations
Israel
Wingate Institute Recruiting
Netanya, Israel, 42902
Contact: Eyal Shargal, PhD    +972-9-8639418    eyals@wingate.org.il   
Sub-Investigator: Einat Mei-Dan, BPT         
Sponsors and Collaborators
Wingate Institute
Investigators
Study Director: gali dar, Phd Wingate Institute
  More Information

No publications provided

Responsible Party: Dr. Eyal Shargal, Professional director, Sports Medicine Sciences and Research,, Wingate Institute
ClinicalTrials.gov Identifier: NCT01460004     History of Changes
Other Study ID Numbers: Winphys01
Study First Received: October 5, 2011
Last Updated: December 31, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Wingate Institute:
patellar tendinopathy
jumper's knee

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on April 16, 2014