Effect of the Infrapatellar Strap and Elastic Band Iin Athletes With Patellofemoral Pain Syndrome

February 11, 2020 updated by: Christiane Macedo, Universidade Estadual de Londrina

Effect of the Infrapatellar Strap and Elastic Band on the Pain, Agility, Balance and Lower Limb Function Athletes With Patellofemoral Pain Syndrome

Patellofemoral Pain Syndrome (PPS) is common in athletes, especially when performing jumps. To reduce pain and improve functionality, orthoses such as the infrapatellar strip (IPS) and functional bandage (FB) are indicated, but their effects are controversial. The objective is to evaluate the effect of IPS and FB on lower limb pain, agility, balance and strength in athletes with PPS. Will be evaluated 25 athletes with PPS (10 women and 15 men), who will answer the sample characterization questionnaires, pain scale and performed the Side Hope Test (SHT), modified star excursion balance test (SEBTm) and Sit to Stand 30 in seconds (STS30 ") to analyze lower limb agility, balance and strength, respectively. Three repetitions of each functional test will be performed, with an interval of one minute between repetitions and tests. Still, the tests will be developed with IPS, with FB and without any orthosis, with previously randomized sequence. Expected to establish the effects of IPS and FB for athletes with PPS.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The research was approved by the ethics committee of the institution. The sample size was calculated in 18 athletes, but when considering losses 25 athletes (10 women and 15 men) were recruited.

Athletes will be over 18 years old, from different sports or teams, with a minimum of six hours / week of training / competition, with complaints of anterior knee pain (DAJ) greater than 3 on the visual analog scale (VAS), rating lower than or equal to 82 (tendency to patellofemoral disorder) in the Anterior Knee Pain Scale (AKPS) and score lower than or equal to 83 (fair or poor) on the Lysholm questionnaire. Exclusion criteria will be the history of other lower limb injuries or surgery; diabetes or altered sensitivity in the plantar region; medication and physical therapy use in the last three months.

For data collection athletes will answer the sample characterization questionnaires, AKPS and Lysholm.

Modified star excursion balance test (SEBTm), Side Hope test (SHT) and 30 second sit-up test (SL30 '') will be applied, at random and with prior familiarization, for the analysis of dynamic balance, agility and lower limb strength, respectively.

It will also be randomized the tests with Infrapatellar Strap, Elastic Bandage and without orthosis (control), developed in three different days with 96 hours interval. To apply the infrapatellar strap and elastic bandage, the athlete was positioned standing with slight knee flexion, with heel support on a pre-established surface (relaxed patellar tendon). The Infrapatellar Strap and Elastic Bandage will be positioned over the patellar tendon, with moderate pressure, on the lower limb complaining of pain.

The tests: SEBTm test, Side Hope test (SHT), and 30-second sit-up (STS 30 '') will be repeated three times, with a one-minute interval between trials and five minutes between tests. At the beginning and end of each test, the analogue visual pain scale (VAS) for knee pain will be applied.

Statistical data will be analyzed using the Statistical Package of Social Science (SPSS®) program, version 22 and a significance level of 5% (p <0.05). ANOVA two way test will be used to compare groups, times and their interaction.

Study Type

Interventional

Enrollment (Anticipated)

25

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

  • Brazil
    • Paraná
      • Londrina, Paraná, Brazil, 86038-350
        • University Hospital of the State University of Londrina

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

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Athletes will be over 18 years old,
  • From different sports or teams,
  • With a minimum of six hours / week of training / competition,
  • With complaints of anterior knee pain (DAJ) greater than 3 on the visual analog scale (VAS)
  • Rating lower than or equal to 82 (tendency to patellofemoral disorder) in the Anterior Knee Pain Scale (AKPS)
  • Score lower than or equal to 83 (fair or poor) on the Lysholm questionnaire.

Exclusion Criteria:

  • History of other lower limb injuries or surgery,
  • Diabetes,
  • Altered sensitivity in the plantar region,
  • Medication to pain,
  • Physical therapy use in the last three months.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Infrapatellar strap
This group will perform the functional tests with the infrapatellar strap positioned on the painful knee.
Device: Infrapatellar strap
Orthotic device which is positioned over the patellar tendon
Other Names:
  • Infrapatellar strip
Experimental: Elastic Band
This group will perform the functional tests with the elastic band positioned on the painful knee.
Other: Elastic band
Orthotic device which is positioned over the patellar tendon
Other Names:
  • Elastic bandage
No Intervention: Control
This group will perform the functional tests without elastic band or infrapatellar strap positioned on the painful knee.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain intensity
Time Frame: Evaluations will be conducted throughout the project data collection. The evaluations have an average time of three months.
The pain will be evaluated before and after the functional tests with infrapatellar strap and elastic band, through the analogue visual pain scale (with pain characterization from zero to ten).
Evaluations will be conducted throughout the project data collection. The evaluations have an average time of three months.
Balance - Modified star excursion balance test (SEBTm)
Time Frame: Evaluations will be conducted throughout the project data collection. The evaluations have an average time of three months.
For the analysis of SEBTm the normalization of the directions will be develop througt the length ot the lower limb of each participant (maximum distance reached in 3 directions (anteior, postero-lateral and postero-medial) / (limb length x 3) x 100 = percentage of the three directions. Distance traveled in centimeters (on a measuring tape) in the anterior, postero-medial and postero-lateral directions.
Evaluations will be conducted throughout the project data collection. The evaluations have an average time of three months.
Agility - Side Hope test (SHT)
Time Frame: Evaluations will be conducted throughout the project data collection. The evaluations have an average time of three months.
For the SHT analysis will be consideres the time requered for the athlete to perform 10 lateral jumps was considered.
Evaluations will be conducted throughout the project data collection. The evaluations have an average time of three months.
Endurance - 30 second sit to stand test (STS30 '')
Time Frame: Evaluations will be conducted throughout the project data collection. The evaluations have an average time of three months.
For the 30" Sit and Lift Test it will be considered for analysis only complete cycles with full knee extension and seat weight unloading.
Evaluations will be conducted throughout the project data collection. The evaluations have an average time of three months.

Collaborators and Investigators

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

Sponsor

Universidade Estadual de Londrina

Investigators

  • Principal Investigator: Christiane S Macedo, State University of Londrina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

March 5, 2020

Primary Completion (Anticipated)

May 5, 2020

Study Completion (Anticipated)

October 5, 2020

Study Registration Dates

First Submitted

December 2, 2019

First Submitted That Met QC Criteria

February 10, 2020

First Posted (Actual)

February 11, 2020

Study Record Updates

Last Update Posted (Actual)

February 13, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Strap in patelofemoral pain.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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