search
Back to results

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

Primary Purpose

Recruitment

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Infrapatellar strap
Elastic band
Sponsored by
Universidade Estadual de Londrina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recruitment focused on measuring Patellofemoral Pain Syndrome, Physiotherapy, Knee, Orthoses

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital of the State University of Londrina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Infrapatellar strap

Elastic Band

Control

Arm Description

This group will perform the functional tests with the infrapatellar strap positioned on the painful knee.

This group will perform the functional tests with the elastic band positioned on the painful knee.

This group will perform the functional tests without elastic band or infrapatellar strap positioned on the painful knee.

Outcomes

Primary Outcome Measures

Change in pain intensity
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).
Balance - Modified star excursion balance test (SEBTm)
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.
Agility - Side Hope test (SHT)
For the SHT analysis will be consideres the time requered for the athlete to perform 10 lateral jumps was considered.
Endurance - 30 second sit to stand test (STS30 '')
For the 30" Sit and Lift Test it will be considered for analysis only complete cycles with full knee extension and seat weight unloading.

Secondary Outcome Measures

Full Information

First Posted
December 2, 2019
Last Updated
February 11, 2020
Sponsor
Universidade Estadual de Londrina
search

1. Study Identification

Unique Protocol Identification Number
NCT04264429
Brief Title
Effect of the Infrapatellar Strap and Elastic Band Iin Athletes With Patellofemoral Pain Syndrome
Official Title
Effect of the Infrapatellar Strap and Elastic Band on the Pain, Agility, Balance and Lower Limb Function Athletes With Patellofemoral Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2020 (Anticipated)
Primary Completion Date
May 5, 2020 (Anticipated)
Study Completion Date
October 5, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual de Londrina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recruitment
Keywords
Patellofemoral Pain Syndrome, Physiotherapy, Knee, Orthoses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Infrapatellar strap
Arm Type
Experimental
Arm Description
This group will perform the functional tests with the infrapatellar strap positioned on the painful knee.
Arm Title
Elastic Band
Arm Type
Experimental
Arm Description
This group will perform the functional tests with the elastic band positioned on the painful knee.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will perform the functional tests without elastic band or infrapatellar strap positioned on the painful knee.
Intervention Type
Device
Intervention Name(s)
Infrapatellar strap
Other Intervention Name(s)
Infrapatellar strip
Intervention Description
Orthotic device which is positioned over the patellar tendon
Intervention Type
Other
Intervention Name(s)
Elastic band
Other Intervention Name(s)
Elastic bandage
Intervention Description
Orthotic device which is positioned over the patellar tendon
Primary Outcome Measure Information:
Title
Change in pain intensity
Description
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).
Time Frame
Evaluations will be conducted throughout the project data collection. The evaluations have an average time of three months.
Title
Balance - Modified star excursion balance test (SEBTm)
Description
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.
Time Frame
Evaluations will be conducted throughout the project data collection. The evaluations have an average time of three months.
Title
Agility - Side Hope test (SHT)
Description
For the SHT analysis will be consideres the time requered for the athlete to perform 10 lateral jumps was considered.
Time Frame
Evaluations will be conducted throughout the project data collection. The evaluations have an average time of three months.
Title
Endurance - 30 second sit to stand test (STS30 '')
Description
For the 30" Sit and Lift Test it will be considered for analysis only complete cycles with full knee extension and seat weight unloading.
Time Frame
Evaluations will be conducted throughout the project data collection. The evaluations have an average time of three months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christiane SG Macedo, PhD
Phone
43991015123
Email
chmacedouel@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christiane S Macedo
Organizational Affiliation
State University of Londrina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of the State University of Londrina
City
Londrina
State/Province
Paraná
ZIP/Postal Code
86038-350
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30059951
Citation
Coburn SL, Barton CJ, Filbay SR, Hart HF, Rathleff MS, Crossley KM. Quality of life in individuals with patellofemoral pain: A systematic review including meta-analysis. Phys Ther Sport. 2018 Sep;33:96-108. doi: 10.1016/j.ptsp.2018.06.006. Epub 2018 Jun 28.
Results Reference
background
PubMed Identifier
21912298
Citation
Straub RK, Cipriani DJ. Influence of infrapatellar and suprapatellar straps on quadriceps muscle activity and onset timing during the body-weight squat. J Strength Cond Res. 2012 Jul;26(7):1827-37. doi: 10.1519/JSC.0b013e318234e81d.
Results Reference
background
PubMed Identifier
29925502
Citation
Collins NJ, Barton CJ, van Middelkoop M, Callaghan MJ, Rathleff MS, Vicenzino BT, Davis IS, Powers CM, Macri EM, Hart HF, de Oliveira Silva D, Crossley KM. 2018 Consensus statement on exercise therapy and physical interventions (orthoses, taping and manual therapy) to treat patellofemoral pain: recommendations from the 5th International Patellofemoral Pain Research Retreat, Gold Coast, Australia, 2017. Br J Sports Med. 2018 Sep;52(18):1170-1178. doi: 10.1136/bjsports-2018-099397. Epub 2018 Jun 20.
Results Reference
background
PubMed Identifier
26376953
Citation
de Vries A, Zwerver J, Diercks R, Tak I, van Berkel S, van Cingel R, van der Worp H, van den Akker-Scheek I. Effect of patellar strap and sports tape on pain in patellar tendinopathy: A randomized controlled trial. Scand J Med Sci Sports. 2016 Oct;26(10):1217-24. doi: 10.1111/sms.12556. Epub 2015 Sep 17.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs