Effect of the Infrapatellar Strap and Elastic Band Iin Athletes With Patellofemoral Pain Syndrome
1 other identifier
interventional
25
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2019
CompletedFirst Posted
Study publicly available on registry
February 11, 2020
CompletedStudy Start
First participant enrolled
March 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2020
CompletedFebruary 13, 2020
February 1, 2020
2 months
December 2, 2019
February 11, 2020
Conditions
Keywords
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
EXPERIMENTALThis group will perform the functional tests with the infrapatellar strap positioned on the painful knee.
Elastic Band
EXPERIMENTALThis group will perform the functional tests with the elastic band positioned on the painful knee.
Control
NO INTERVENTIONThis 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
Orthotic device which is positioned over the patellar tendon
Eligibility Criteria
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
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: 30059951BACKGROUNDStraub 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: 21912298BACKGROUNDCollins 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: 29925502BACKGROUNDde 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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christiane S Macedo
State University of Londrina
Central Study Contacts
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