RecruitmentNCT04264429
Effect of the Infrapatellar Strap and Elastic Band Iin Athletes With Patellofemoral Pain Syndrome
A study testing Infrapatellar strap and Elastic band in people with Recruitment, run by Universidade Estadual de Londrina at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Recruitment
- What is being tested?
- Infrapatellar strap and Elastic band
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Mar 2020to 5 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University Hospital of the State University of Londrina
Londrina, Paraná, 86038-350
About this study
Official title: Effect of the Infrapatellar Strap and Elastic Band on the Pain, Agility, Balance and Lower Limb Function Athletes With Patellofemoral Pain Syndrome
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.
Read the 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.
- Conditions
- Recruitment
- Being tested
- Infrapatellar strap, Elastic band
- Keywords
- Patellofemoral Pain Syndrome, Physiotherapy, Knee, Orthoses
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrapatellar strapDevice
Also called Infrapatellar strip
Orthotic device which is positioned over the patellar tendon
Elastic bandOther
Also called Elastic bandage
Orthotic device which is positioned over the patellar tendon
| Study group | Role | What they receive |
|---|---|---|
| Infrapatellar strap | Experimental | This group will perform the functional tests with the infrapatellar strap positioned on the painful knee. Receives: Device: Infrapatellar strap |
| Elastic Band | Experimental | This group will perform the functional tests with the elastic band positioned on the painful knee. Receives: Other: Elastic band |
| Control | No intervention | This group will perform the functional tests without elastic band or infrapatellar strap positioned on the painful knee. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Evaluations will be conducted throughout the project data collection. The evaluations have an average time of three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start5 Mar 2020 (estimated)
- Primary completion5 May 2020 (estimated)
- Study completion5 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for RecruitmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christiane Macedo, Universidade Estadual de Londrina
- Investigators
- Christiane S Macedo, Principal investigator, State University of Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264429
- Sponsor's protocol ID
- Strap in patelofemoral pain.
- Status last verified
- Feb 2020
- First submitted
- 2 Dec 2019
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30059951Straub 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.
PubMed 21912298Collins 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.
PubMed 29925502de 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.
PubMed 26376953
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Infrapatellar Strap and Elastic Band on the Pain, Agility, Balance and Lower Limb Function Athletes With Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT04264429
- Acronym / sponsor ID
- Strap in patelofemoral pain.
- Conditions
- Recruitment
- Keywords
- Patellofemoral Pain Syndrome, Physiotherapy, Knee, Orthoses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- 5 Mar 2020 (estimated)
- Primary completion
- 5 May 2020 (estimated)
- Study completion
- 5 Oct 2020 (estimated)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 <0.05). ANOVA two way test will be used to compare groups, times and their interaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infrapatellar strap | Experimental | Device: Infrapatellar strapThis group will perform the functional tests with the infrapatellar strap positioned on the painful knee. |
| Elastic Band | Experimental | Other: Elastic bandThis group will perform the functional tests with the elastic band positioned on the painful knee. |
| Control | No intervention | –This group will perform the functional tests without elastic band or infrapatellar strap positioned on the painful knee. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrapatellar strapAlso: Infrapatellar stripOrthotic device which is positioned over the patellar tendon | Device | Infrapatellar strap |
| Elastic bandAlso: Elastic bandageOrthotic device which is positioned over the patellar tendon | Other | Elastic Band |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Background: PubMed 30059951Coburn 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.
- Background: PubMed 21912298Straub 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.
- Background: PubMed 29925502Collins 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.
- Background: PubMed 26376953de 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiane S Macedo principal investigator
State University of Londrina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infrapatellar strap and Elastic band in people with Recruitment, run by Universidade Estadual de Londrina at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christiane SG Macedo, PhD (43991015123, chmacedouel@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04264429, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.