Effect of the Infrapatellar Strap and Elastic Band Iin Athletes With Patellofemoral Pain Syndrome

NCT ID: NCT04264429

Last Updated: 2020-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-05

Study Completion Date

2020-10-05

Brief Summary

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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

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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.

Conditions

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Recruitment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Infrapatellar strap

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

Group Type EXPERIMENTAL

Infrapatellar strap

Intervention Type DEVICE

Orthotic device which is positioned over the patellar tendon

Elastic Band

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

Group Type EXPERIMENTAL

Elastic band

Intervention Type OTHER

Orthotic device which is positioned over the patellar tendon

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Infrapatellar strap

Orthotic device which is positioned over the patellar tendon

Intervention Type DEVICE

Elastic band

Orthotic device which is positioned over the patellar tendon

Intervention Type OTHER

Other Intervention Names

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Infrapatellar strip Elastic bandage

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Estadual de Londrina

OTHER

Sponsor Role lead

Responsible Party

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Christiane Macedo

Principal investigator and Professor.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christiane S Macedo

Role: PRINCIPAL_INVESTIGATOR

State University of Londrina

Locations

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University Hospital of the State University of Londrina

Londrina, Paraná, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Christiane SG Macedo, PhD

Role: CONTACT

43991015123

References

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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.

Reference Type BACKGROUND
PMID: 30059951 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21912298 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29925502 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26376953 (View on PubMed)

Other Identifiers

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Strap in patelofemoral pain.

Identifier Type: -

Identifier Source: org_study_id

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