NCT04264429

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

March 5, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2020

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

December 2, 2019

Last Update Submit

February 11, 2020

Conditions

Keywords

Patellofemoral Pain SyndromePhysiotherapyKneeOrthoses

Outcome Measures

Primary Outcomes (4)

  • 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).

    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)

    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)

    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 '')

    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.

Study Arms (3)

Infrapatellar strap

EXPERIMENTAL

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

Device: Infrapatellar strap

Elastic Band

EXPERIMENTAL

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

Other: Elastic band

Control

NO INTERVENTION

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

Interventions

Orthotic device which is positioned over the patellar tendon

Also known as: Infrapatellar strip
Infrapatellar strap

Orthotic device which is positioned over the patellar tendon

Also known as: Elastic bandage
Elastic Band

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of the State University of Londrina

Londrina, ParanĂ¡, 86038-350, Brazil

Location

Related Publications (4)

  • 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.

    PMID: 30059951BACKGROUND
  • 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.

    PMID: 21912298BACKGROUND
  • 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.

    PMID: 29925502BACKGROUND
  • 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.

    PMID: 26376953BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Compression Bandages

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

BandagesEquipment and Supplies

Study Officials

  • Christiane S Macedo

    State University of Londrina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christiane SG Macedo, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator and Professor.

Study Record Dates

First Submitted

December 2, 2019

First Posted

February 11, 2020

Study Start

March 5, 2020

Primary Completion

May 5, 2020

Study Completion

October 5, 2020

Last Updated

February 13, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations