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

• ClinicalTrials.gov Identifier: NCT01460004
• Recruitment Status: Completed
• First Posted: October 26, 2011
• Last Update Posted: July 17, 2015
• Sponsor: Wingate Institute
• Information provided by (Responsible Party): Dr. Eyal Shargal, Wingate Institute

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.

Condition or disease	Intervention/treatment	Phase
Patellar Tendonitis; Jumper's Knee; Patellar Tendinopathy	Device: patella knee strap	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: January 2012
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

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 Name: FDA regulation number 890.3475

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 18 Years (Child, Adult)
• Sexes 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

Locations

Israel

Wingate Institute

Netanya, Israel, 42902

Sponsors and Collaborators

Wingate Institute

Investigators

• Study Director: gali dar, Phd; Wingate Institute

More Information

• Responsible Party: Dr. Eyal Shargal, Professional director, Sports Medicine Sciences and Research,, Wingate Institute
• ClinicalTrials.gov Identifier: NCT01460004
• Other Study ID Numbers: Winphys01
• First Posted: October 26, 2011
• Last Update Posted: July 17, 2015
• Last Verified: July 2015

Keywords provided by Dr. Eyal Shargal, Wingate Institute:

patellar tendinopathy; jumper's knee

Additional relevant MeSH terms:

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries