Patellofemoral Pain SyndromeNCT02837289
Activation of Hip Muscles in Runners With Patellofemoral Syndrome
A study testing Therapy taping in people with Patellofemoral Pain Syndrome, run by Universidade Estadual de Londrina at 1 site in Brazil.
Trial summary
Introduction: Hip motor control deficit and neuromuscular disorders of the gluteus medius influence the mechanics of patellofemoral joints through increased dynamic knee valgus and can lead to Patellofemoral Pain Syndrome (PFPS). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Therapy taping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2016to 3 May 2017
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- History of severe / traumatic knee injury, surgery history in the locomotor system;
- Patellar luxation history; clinical evidence of meniscus injury; ligamentous instability; patellar tendinitis.
- Presence of neurological, cardiovascular or rheumatologic diseases; pregnancy; diabetes,
- Abnormal sensitivity in the plantar;
- Medication and / or therapy in the last six months and hypersensitivity or allergy to tape.
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: Activation of Hip Muscles in Runners With Patellofemoral Syndrome: Double-blind Randomized Clinical Trial
Introduction: Hip motor control deficit and neuromuscular disorders of the gluteus medius influence the mechanics of patellofemoral joints through increased dynamic knee valgus and can lead to Patellofemoral Pain Syndrome (PFPS). Mechanoreceptors can be stimulated by an elastic tape, which sends desired tactile cues via afferent improving the functional support of the musculoskeletal system.
Objective: To analyze the response to hip stabilizer muscle activation in street runners with PFPS through the application of elastic tape therapy.
Read more
Methods: The investigators evaluated street runners between the ages of 18 and 45, who run at least 5km/week and had been suffering from pain for at least 3 months. The volunteers had been assessed in relation to their measurements, experience of pain and training routine, their medius muscle (GM) and biceps femoris muscle (BF) had also been tested with surface electromyography through pre-determined performance tests. The participants of both groups wore a bandage for 6 weeks (1 per week). However for the participants of the placebo group the investigators applied a different anatomical path without tension, eliminating all the therapeutic elements. The volunteers were reassessed following the trial.
Hypothesis: Expected to observe that elastic tape therapy do result in any improvement in the activation of hip muscles and improvement of pain in street runners with patellofemoral pain syndrome.
Read the detailed description
Will be recruited individuals 18-45 years of age, of at least running frequency 5 km/week and history of pain in the knee for at least three months in two or more of the following listed activities: up or down stairs, squatting, kneeling , jump, long time sitting or pain on palpation of the lateral side / medial patella.
Will be included individuals without cardiovascular diseases, which have not undergone surgery of the lower limbs in the last two years without back pain and without injury to the hip or knee. They will be excluded from those presenting allergy to the use of elastic bandage or who can not remain with the use of it during the stipulated period. Participants will sign an informed consent and informed, prior to the start of collections.
Data collection was developed with a electromyography (EMG) for muscle data and questionnaire with participants by a blinded examiner initially will be held. The questionnaire consists of the Visual Analogue Scale (VAS). For EMG of the gluteus medius (GM) and biceps femoris (BF), the electrodes are positioned according to the protocols of Surface Electromyography for the Non-Invasive Assessment of Muscles (SENIAM), with the reference electrode located in anterior tibial tuberosity. The application site will be prepared with abrasion and cleansing the skin with 70% alcohol and trichotomy. The maneuver of maximum voluntary isometric contraction (MVIC) will be trained and previously performed the collection, with five seconds support for normalization of data to the gluteus medius and biceps. Among the MVICs every muscle will hold a minute's rest. The muscle activity recorded during the exercises will be expressed in percentage of MVIC. After maneuvers MVIC, individuals will rest for five minutes and then immediately to start the acquisition of electromyographic data during functional tests.
For this, individuals previously will be guided and trained to realize them. During testing, barefoot athletes will be positioned on one foot on the leg with more intense pain complaints, contralateral leg approximately 70 ° of knee flexion, relaxed upper body next to the body, torso upright and keeping focused look a marking affixed to the wall at eye level. In the first test, prompted a squat (AG) of approximately 45 ° of knee flexion, with one foot; in the second test, the same squat will be held, but followed by maximum external rotation (ROT-AG) in the hip support. The cadence of the movement will be standardized and guided by the appraiser to be started and completed in 10 seconds. Functional tests are designed to simulate the action of the hip muscles in the race support phase and motor control of the lower limb.
After electromyographic reviews, be held to randomization to the control group and treatment through and opaque sealed envelopes, by a blinded evaluator. Individuals of both groups will be submitted to the application of the bandage on the leg with pain complaints. For this, a qualified professional trained for the bandage application in relation to anatomical landmarks and elastic tension of the application, without the knowledge, so as to physiology or function thereof. Will be used two techniques in the intervention group. For the placebo group, the application of the bandage will follow a different anatomical path without tension, eliminating all therapeutic process elements.
The groups will be followed for six weeks and will be guided them to keep their daily routine. Each week, individuals remain five days with the application of the bandage, and two days without, to avoid possible adverse effects of excessive and constant use of it. After this, a new bandage will be applied by the same trained professional, following the protocols already mentioned. After six weeks, the volunteers return for reevaluation.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Therapy taping, Placebo taping
- Keywords
- patellofemoral pain syndrome, therapy taping, knee, physical therapy, runners
- 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.
Therapy tapingOther
Therapy taping follows an anatomical pattern from the femur until tibia for correction of dynamic valgus with therapy taping.
Placebo tapingOther
Placebo taping follows a different anatomical path without tension, eliminating all therapeutic process elements
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Therapy taping follows an anatomical pattern from the femur until tibia for correction of dynamic valgus with therapy taping. Receives: Other: Therapy taping |
| Placebo | Other | Placebo taping follows a different anatomical path without tension, eliminating all therapeutic process elements Receives: Other: Placebo taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in muscle activation by electromyography after treatment with therapy taping
Willy et al (2013) suggest that interventions that seek biomechanical correction of the hip can reduce retropatellar pressure and improve the pain and function of individuals with PFD. Thus, it is sought to increase or reduce muscular activation, with a response in the locomotor system, which is confirmed by Hsu (2009) evidencing the relation of the elastic bandage to the muscular activation level. Slupik et al (2007) sought to determine the effect of the elastic bandage on the medial vastus muscle tone during isometric contractions, and they concluded that the bandage offered better support for the musculoskeletal system.
Measured: before and after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study start1 Jul 2016
- Primary completion2 Jul 2016
- Study completion3 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
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 Macedo, doctor, Principal investigator, Universidade Estadual de Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837289
- Sponsor's protocol ID
- therapy taping in runners
- Status last verified
- Nov 2017
- First submitted
- 12 Jul 2016
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Fukuda TY, Rossetto FM, Magalhaes E, Bryk FF, Lucareli PR, de Almeida Aparecida Carvalho N. Short-term effects of hip abductors and lateral rotators strengthening in females with patellofemoral pain syndrome: a randomized controlled clinical trial. J Orthop Sports Phys Ther. 2010 Nov;40(11):736-42. doi: 10.2519/jospt.2010.3246.
PubMed 21041965Willy RW, Davis IS. Varied response to mirror gait retraining of gluteus medius control, hip kinematics, pain, and function in 2 female runners with patellofemoral pain. J Orthop Sports Phys Ther. 2013 Dec;43(12):864-74. doi: 10.2519/jospt.2013.4516. Epub 2013 Oct 30.
PubMed 24175611Hsu YH, Chen WY, Lin HC, Wang WT, Shih YF. The effects of taping on scapular kinematics and muscle performance in baseball players with shoulder impingement syndrome. J Electromyogr Kinesiol. 2009 Dec;19(6):1092-9. doi: 10.1016/j.jelekin.2008.11.003. Epub 2009 Jan 14.
PubMed 19147374Slupik A, Dwornik M, Bialoszewski D, Zych E. Effect of Kinesio Taping on bioelectrical activity of vastus medialis muscle. Preliminary report. Ortop Traumatol Rehabil. 2007 Nov-Dec;9(6):644-51. English, Polish.
PubMed 18227756Thelen MD, Dauber JA, Stoneman PD. The clinical efficacy of kinesio tape for shoulder pain: a randomized, double-blinded, clinical trial. J Orthop Sports Phys Ther. 2008 Jul;38(7):389-95. doi: 10.2519/jospt.2008.2791. Epub 2008 May 29.
PubMed 18591761
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activation of Hip Muscles in Runners With Patellofemoral Syndrome: Double-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02837289
- Acronym / sponsor ID
- therapy taping in runners
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- patellofemoral pain syndrome, therapy taping, knee, physical therapy, runners
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- 1 Jul 2016
- Primary completion
- 2 Jul 2016 (actual)
- Study completion
- 3 May 2017 (actual)
- First posted
- 19 Jul 2016 (estimated)
- 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.
Introduction: Hip motor control deficit and neuromuscular disorders of the gluteus medius influence the mechanics of patellofemoral joints through increased dynamic knee valgus and can lead to Patellofemoral Pain Syndrome (PFPS). Mechanoreceptors can be stimulated by an elastic tape, which sends desired tactile cues via afferent improving the functional support of the musculoskeletal system.
Objective: To analyze the response to hip stabilizer muscle activation in street runners with PFPS through the application of elastic tape therapy.
Methods: The investigators evaluated street runners between the ages of 18 and 45, who run at least 5km/week and had been suffering from pain for at least 3 months. The volunteers had been assessed in relation to their measurements, experience of pain and training routine, their medius muscle (GM) and biceps femoris muscle (BF) had also been tested with surface electromyography through pre-determined performance tests. The participants of both groups wore a bandage for 6 weeks (1 per week). However for the participants of the placebo group the investigators applied a different anatomical path without tension, eliminating all the therapeutic elements. The volunteers were reassessed following the trial.
Hypothesis: Expected to observe that elastic tape therapy do result in any improvement in the activation of hip muscles and improvement of pain in street runners with patellofemoral pain syndrome.
Detailed description
Will be recruited individuals 18-45 years of age, of at least running frequency 5 km/week and history of pain in the knee for at least three months in two or more of the following listed activities: up or down stairs, squatting, kneeling , jump, long time sitting or pain on palpation of the lateral side / medial patella.
Will be included individuals without cardiovascular diseases, which have not undergone surgery of the lower limbs in the last two years without back pain and without injury to the hip or knee. They will be excluded from those presenting allergy to the use of elastic bandage or who can not remain with the use of it during the stipulated period. Participants will sign an informed consent and informed, prior to the start of collections.
Data collection was developed with a electromyography (EMG) for muscle data and questionnaire with participants by a blinded examiner initially will be held. The questionnaire consists of the Visual Analogue Scale (VAS). For EMG of the gluteus medius (GM) and biceps femoris (BF), the electrodes are positioned according to the protocols of Surface Electromyography for the Non-Invasive Assessment of Muscles (SENIAM), with the reference electrode located in anterior tibial tuberosity. The application site will be prepared with abrasion and cleansing the skin with 70% alcohol and trichotomy. The maneuver of maximum voluntary isometric contraction (MVIC) will be trained and previously performed the collection, with five seconds support for normalization of data to the gluteus medius and biceps. Among the MVICs every muscle will hold a minute's rest. The muscle activity recorded during the exercises will be expressed in percentage of MVIC. After maneuvers MVIC, individuals will rest for five minutes and then immediately to start the acquisition of electromyographic data during functional tests.
For this, individuals previously will be guided and trained to realize them. During testing, barefoot athletes will be positioned on one foot on the leg with more intense pain complaints, contralateral leg approximately 70 ° of knee flexion, relaxed upper body next to the body, torso upright and keeping focused look a marking affixed to the wall at eye level. In the first test, prompted a squat (AG) of approximately 45 ° of knee flexion, with one foot; in the second test, the same squat will be held, but followed by maximum external rotation (ROT-AG) in the hip support. The cadence of the movement will be standardized and guided by the appraiser to be started and completed in 10 seconds. Functional tests are designed to simulate the action of the hip muscles in the race support phase and motor control of the lower limb.
After electromyographic reviews, be held to randomization to the control group and treatment through and opaque sealed envelopes, by a blinded evaluator. Individuals of both groups will be submitted to the application of the bandage on the leg with pain complaints. For this, a qualified professional trained for the bandage application in relation to anatomical landmarks and elastic tension of the application, without the knowledge, so as to physiology or function thereof. Will be used two techniques in the intervention group. For the placebo group, the application of the bandage will follow a different anatomical path without tension, eliminating all therapeutic process elements.
The groups will be followed for six weeks and will be guided them to keep their daily routine. Each week, individuals remain five days with the application of the bandage, and two days without, to avoid possible adverse effects of excessive and constant use of it. After this, a new bandage will be applied by the same trained professional, following the protocols already mentioned. After six weeks, the volunteers return for reevaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Other: Therapy tapingTherapy taping follows an anatomical pattern from the femur until tibia for correction of dynamic valgus with therapy taping. |
| Placebo | Other | Other: Placebo tapingPlacebo taping follows a different anatomical path without tension, eliminating all therapeutic process elements |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- History of severe / traumatic knee injury, surgery history in the locomotor system;
- Patellar luxation history; clinical evidence of meniscus injury; ligamentous instability; patellar tendinitis.
- Presence of neurological, cardiovascular or rheumatologic diseases; pregnancy; diabetes,
- Abnormal sensitivity in the plantar;
- Medication and / or therapy in the last six months and hypersensitivity or allergy to tape.
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 |
|---|---|---|
| Therapy tapingTherapy taping follows an anatomical pattern from the femur until tibia for correction of dynamic valgus with therapy taping. | Other | Treatment |
| Placebo tapingPlacebo taping follows a different anatomical path without tension, eliminating all therapeutic process elements | Other | Placebo |
Primary outcome
Changes in muscle activation by electromyography after treatment with therapy taping
Time frame: before and after 6 weeks of intervention
Willy et al (2013) suggest that interventions that seek biomechanical correction of the hip can reduce retropatellar pressure and improve the pain and function of individuals with PFD. Thus, it is sought to increase or reduce muscular activation, with a response in the locomotor system, which is confirmed by Hsu (2009) evidencing the relation of the elastic bandage to the muscular activation level. Slupik et al (2007) sought to determine the effect of the elastic bandage on the medial vastus muscle tone during isometric contractions, and they concluded that the bandage offered better support for the musculoskeletal system.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Background: PubMed 21041965Fukuda TY, Rossetto FM, Magalhaes E, Bryk FF, Lucareli PR, de Almeida Aparecida Carvalho N. Short-term effects of hip abductors and lateral rotators strengthening in females with patellofemoral pain syndrome: a randomized controlled clinical trial. J Orthop Sports Phys Ther. 2010 Nov;40(11):736-42. doi: 10.2519/jospt.2010.3246.
- Background: PubMed 24175611Willy RW, Davis IS. Varied response to mirror gait retraining of gluteus medius control, hip kinematics, pain, and function in 2 female runners with patellofemoral pain. J Orthop Sports Phys Ther. 2013 Dec;43(12):864-74. doi: 10.2519/jospt.2013.4516. Epub 2013 Oct 30.
- Background: PubMed 19147374Hsu YH, Chen WY, Lin HC, Wang WT, Shih YF. The effects of taping on scapular kinematics and muscle performance in baseball players with shoulder impingement syndrome. J Electromyogr Kinesiol. 2009 Dec;19(6):1092-9. doi: 10.1016/j.jelekin.2008.11.003. Epub 2009 Jan 14.
- Background: PubMed 18227756Slupik A, Dwornik M, Bialoszewski D, Zych E. Effect of Kinesio Taping on bioelectrical activity of vastus medialis muscle. Preliminary report. Ortop Traumatol Rehabil. 2007 Nov-Dec;9(6):644-51. English, Polish.
- Results publication: PubMed 18591761Thelen MD, Dauber JA, Stoneman PD. The clinical efficacy of kinesio tape for shoulder pain: a randomized, double-blinded, clinical trial. J Orthop Sports Phys Ther. 2008 Jul;38(7):389-95. doi: 10.2519/jospt.2008.2791. Epub 2008 May 29.
- 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 Macedo, doctor principal investigator
Universidade Estadual de 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 Therapy taping in people with Patellofemoral Pain Syndrome, 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 0 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: finished, as of the sponsor's last update on 2 Dec 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in muscle activation by electromyography after treatment with therapy taping (time frame: before and after 6 weeks of intervention). 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 NCT02837289, which also lists 5 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 2 Dec 2017.