Ignite Creation Date:
2024-05-06 @ 2:15 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04264429
Status:
UNKNOWN
Last Update Posted:
2020-02-13
First Post:
2019-12-02
Brief Title:
Effect of the Infrapatellar Strap and Elastic Band Iin Athletes With Patellofemoral Pain Syndrome
Sponsor:
Universidade Estadual de Londrina
Organization:
Universidade Estadual de Londrina
Study Overview
Official Title:
Effect of the Infrapatellar Strap and Elastic Band on the Pain Agility Balance and Lower Limb Function Athletes With Patellofemoral Pain Syndrome
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 005 ANOVA two way test will be used to compare groups times and their interaction
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 005 ANOVA two way test will be used to compare groups times and their interaction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None