Effect of the Infrapatellar Strap and Elastic Band Iin Athletes With Patellofemoral Pain Syndrome
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|ClinicalTrials.gov Identifier: NCT04264429|
Recruitment Status : Not yet recruiting
First Posted : February 11, 2020
Last Update Posted : February 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Recruitment||Device: Infrapatellar strap Other: Elastic band||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Effect of the Infrapatellar Strap and Elastic Band on the Pain, Agility, Balance and Lower Limb Function Athletes With Patellofemoral Pain Syndrome|
|Estimated Study Start Date :||March 5, 2020|
|Estimated Primary Completion Date :||May 5, 2020|
|Estimated Study Completion Date :||October 5, 2020|
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 Name: 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 Name: Elastic bandage
No Intervention: Control
This group will perform the functional tests without elastic band or infrapatellar strap positioned on the painful knee.
- 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).
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04264429
|Contact: Christiane SG Macedo, PhDfirstname.lastname@example.org|
|University Hospital of the State University of Londrina|
|Londrina, Paraná, Brazil, 86038-350|
|Principal Investigator:||Christiane S Macedo||State University of Londrina|