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

Patellar Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01460004
• Other study ID #: Winphys01
• Status: Completed
• Phase: N/A
• First received: October 5, 2011
• Last updated: July 16, 2015
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: Wingate Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 14 Years to 18 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Jumper's Knee
• Patellar Tendinopathy
• Patellar Tendonitis
• Tendinopathy

Intervention

Device:
• patella knee strap
infra patella strap 100% cotton pressure is exerted immediately under the patella

Locations

Country	Name	City	State
Israel	Wingate Institute	Netanya

Sponsors (1)

Lead Sponsor	Collaborator
Wingate Institute

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in pain level after applying an infra patellar strap	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.	No
Secondary	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	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.	No