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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
Sponsor:
Information provided by (Responsible Party):
Christiane Macedo, Universidade Estadual de Londrina

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.

Condition or disease Intervention/treatment Phase
Recruitment Device: Infrapatellar strap Other: Elastic band Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Christiane SG Macedo, PhD 43991015123 chmacedouel@yahoo.com.br

Locations
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Brazil
University Hospital of the State University of Londrina
Londrina, Paraná, Brazil, 86038-350
Sponsors and Collaborators
Universidade Estadual de Londrina
Investigators
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Principal Investigator: Christiane S Macedo State University of Londrina
Publications:
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Responsible Party: Christiane Macedo, Principal investigator and Professor., Universidade Estadual de Londrina
ClinicalTrials.gov Identifier: NCT04264429    
Other Study ID Numbers: Strap in patelofemoral pain.
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christiane Macedo, Universidade Estadual de Londrina:
Patellofemoral Pain Syndrome
Physiotherapy
Knee
Orthoses
Additional relevant MeSH terms:
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Patellofemoral Pain Syndrome
Joint Diseases
Musculoskeletal Diseases