Anterior Knee Pain SyndromeTappingNCT02322515
Patellar Taping on Proprioceptive Exercises in Young Women With Patellofemoral Pain Syndrome
A study testing Intervention taping in people with Anterior Knee Pain Syndrome, run by Universidade Norte do Paraná.
Trial summary
The relevance of this study is to determine the effects of a patellar taping on muscle activation of the vastus medialis oblique (VMO), vastus lateralis (VL) and gluteus medius (GM) during different proprioceptive exercises frequently utilized in rehabilitation program. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Anterior Knee Pain Syndrome
- What is being tested?
- Intervention taping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Aug 2015
- 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- anterior or retropatellar knee pain on at least two of the following activities: prolonged sitting, stairs, squatting, running, kneeling, and hopping/jumping,
- pain on patellar palpation,
- pain while stepping down from a 25-cm step or during a double leg squat,
- symptoms for at least 1 month, average pain level of 3 cm or more on a 10-cm VAS.
Who cannot join
- signs or symptoms of other pathology including coexisting pathology, a recent history (within 3 months) of knee surgery,
- history of patellar dislocation/subluxation, or clinical evidence of meniscal lesion, ligamentous instability, traction, apophysitis around the patellofemoral complex, patellar tendon pathology, chondral damage, osteoarthritis, or referred pain from the spine, features that could affect the implementation of the trial,
- previous experience with patellar taping, an inability to attend a physical therapy clinic for a 6-wk treatment program,
- allergic reaction to adhesive tape,
- pregnancy, and an inability to understand the experimental protocol.
About this study
Official title: The Effect of a Patellar Taping on Proprioceptive Exercises in Young Women With Patellofemoral Pain Syndrome: A Single-blinded Randomized Controlled Trial.
The relevance of this study is to determine the effects of a patellar taping on muscle activation of the vastus medialis oblique (VMO), vastus lateralis (VL) and gluteus medius (GM) during different proprioceptive exercises frequently utilized in rehabilitation program.
Read the detailed description
The purpose of this study is to assess the role of the patellar taping on muscle activation during seven proprioceptive exercises in women with the patellofemoral pain syndrome.
Forty voluntary young women (from 18 to 35 years) with three or more clinical symptoms of patellofemoral pain syndrome will be recruited. The participants will answer a clinical questionnaire in regard to knee pain and a specific patellofemoral questionnaire titled: the Anterior Knee Pain Scale (AKPS). All participants will sign an informed consent form approved by the North of Parana University Ethics Committee for Research on Human Subjects. The sample will be randomized in two groups: (G1) the experimental group that will use a rigid patellar taping (n = 20) for the correction in lateralization of the patella and stabilization of the knee. The lateral stabilization will be made with self-adhesive taping positioned in the lateral border of the patella and tensioned in relation to the medial portion of the femur condyle, which allows an edge of the medial board patella and a stretching of lateral structures of the knee. All procedure will follow the recommendation from McConnell studies with regard to the patellar femoral syndrome; and (G2) the placebo group that will use a rigid patellar taping (n = 20), but without no correction of lateralization of the patella and/or stabilization of the knee. The taping will be placed incorrectly such as in the vertical position of knee and without any tension or traction around structures and patella. A computer will be used to generate the randomization sequence of the participants. The allocation will be printed in cards by sequentially numbered in opaque envelopes.
Before performing the exercises, a maximum voluntary isometric contraction will be performed for the knee extensor muscles (e.g. specifically the VMO and VL) and hip abductor muscles (e.g. GM) in order to normalize the signal EMG for determining of the level muscular activity during each exercise, with the correct taping and/or placebo. All participants, after randomization, will perform seven proprioceptive exercises on one leg-stance position in different surfaces: 1) static position in force platform, 2) dynamic in flexion-extension knee on a force platform, 3) anteroposterior sway on rectangular rocker board, 4) mediolateral sway on rectangular rocker board, 5) unipodal standing on a swing apparatus, 6) unipodal standing on a mini-trampoline, and 7) unipodal standing on bosu balance ball. Each exercise has a time of 15 seconds performance, while sway centre of pressure parameters will be computed (exercise #1 and #2), and EMG surface will recording (VMO, VL, GM) for all seven. First, one baseline measure (without taping) will be performed and immediately after with the use of taping (intervention or placebo).
An ANOVA two-way will be performed to compare the two groups (G1 and G2) and two times (before and immediately after with taping) and the effects of interaction (Groups x Times). The size effect also will be computed to determine the rate of the changes observed.
- Conditions
- Anterior Knee Pain Syndrome
- Being tested
- Intervention taping, Placebo Taping
- Keywords
- Knee, Proprioception, Electromyography, Taping
- 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.
Intervention tapingOther
Also called Patellar taping
A rigid patellar taping will be used for the correction in lateralization of the patella and more stabilization of the knee.
Placebo TapingOther
Also called Sham taping
A rigid patellar taping will be used in the vertical position and without no correction in lateralization of the patella and/or stabilization of the knee.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Taping | Experimental | The experimental group will use a rigid patellar taping (G1, n = 22) for the correction of lateralization of the patella and stabilization of the knee. The lateral stabilization will be made with self-adhesive taping positioned in the lateral border of the patella and tensioned in relation to the medial portion of the femur condyle, which allows an edge of the medial board patella and a stretching of lateral structures of the knee. All procedure will follow the recommendation from McConnell studies with regard to the patellar femoral syndrome. Receives: Other: Intervention taping |
| Placebo Taping | Placebo comparator | The placebo group will use a rigid patellar taping (G2, n = 22), but without no correction of lateralization of the patella and/or stabilization of the knee. The taping will be placed incorrectly such as in the vertical position of knee and without any tension or traction around structures and patella. Receives: Other: Placebo Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular activation level (EMG measures)
Surface EMG signals will be record in the the vastus medialis oblique (VMO), vastus lateralis (VL) and gluteus medius (GM) muscles, before and immedialty after with taping, during seven proprioceptive exercises.
Measured: Baseline and immediately after with the taping
Secondary outcomes (1)
Postural control measures (force platform)
Stabilographic analysis of COP data from the force platform will used for the calculation of the main balance parameters of postural instability (ellipse area of COP and velocity sway of COP in both antero-posterior and medio-lateral directions of movement.
Measured: Baseline and immediately after with the taping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionAug 2015
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 Anterior Knee 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, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Norte do Paraná
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Estadual de Londrina
- Responsible party
- Principal investigator, Rubens Alexandre da Silva Jr, Universidade Norte do Paraná
- Investigators
- Rubens A DA SILVA, PhD, Principal investigator, Universidade Norte do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322515
- Sponsor's protocol ID
- Unopar-Rubens
- Acronym
- Tapping
- Status last verified
- Nov 2015
- First submitted
- 15 Dec 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cowan SM, Bennell KL, Crossley KM, Hodges PW, McConnell J. Physical therapy alters recruitment of the vasti in patellofemoral pain syndrome. Med Sci Sports Exerc. 2002 Dec;34(12):1879-85. doi: 10.1097/00005768-200212000-00004.
PubMed 12471291McCONNELL J. The management of chondromalacia patellae: a long term solution. Aust J Physiother. 1986;32(4):215-23. doi: 10.1016/S0004-9514(14)60654-1.
PubMed 25025219Lee SE, Cho SH. The effect of McConnell taping on vastus medialis and lateralis activity during squatting in adults with patellofemoral pain syndrome. J Exerc Rehabil. 2013 Apr;9(2):326-30. doi: 10.12965/jer.130018. Epub 2013 Apr 25.
PubMed 24278879Araujo CG, de Souza Guerino Macedo C, Ferreira D, Shigaki L, da Silva RA. Mcconnell's patellar taping does not alter knee and hip muscle activation differences during proprioceptive exercises: A randomized placebo-controlled trial in women with patellofemoral pain syndrome. J Electromyogr Kinesiol. 2016 Dec;31:72-80. doi: 10.1016/j.jelekin.2016.09.006. Epub 2016 Sep 21.
PubMed 27693990
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Patellar Taping on Proprioceptive Exercises in Young Women With Patellofemoral Pain Syndrome: A Single-blinded Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02322515
- Acronym / sponsor ID
- Tapping / Unopar-Rubens
- Conditions
- Anterior Knee Pain Syndrome
- Keywords
- Knee, Proprioception, Electromyography, Taping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade Norte do ParanáUniversity, hospital or other
- Collaborators
- Universidade Estadual de Londrina
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 23 Dec 2014 (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.
The relevance of this study is to determine the effects of a patellar taping on muscle activation of the vastus medialis oblique (VMO), vastus lateralis (VL) and gluteus medius (GM) during different proprioceptive exercises frequently utilized in rehabilitation program.
Detailed description
The purpose of this study is to assess the role of the patellar taping on muscle activation during seven proprioceptive exercises in women with the patellofemoral pain syndrome.
Forty voluntary young women (from 18 to 35 years) with three or more clinical symptoms of patellofemoral pain syndrome will be recruited. The participants will answer a clinical questionnaire in regard to knee pain and a specific patellofemoral questionnaire titled: the Anterior Knee Pain Scale (AKPS). All participants will sign an informed consent form approved by the North of Parana University Ethics Committee for Research on Human Subjects. The sample will be randomized in two groups: (G1) the experimental group that will use a rigid patellar taping (n = 20) for the correction in lateralization of the patella and stabilization of the knee. The lateral stabilization will be made with self-adhesive taping positioned in the lateral border of the patella and tensioned in relation to the medial portion of the femur condyle, which allows an edge of the medial board patella and a stretching of lateral structures of the knee. All procedure will follow the recommendation from McConnell studies with regard to the patellar femoral syndrome; and (G2) the placebo group that will use a rigid patellar taping (n = 20), but without no correction of lateralization of the patella and/or stabilization of the knee. The taping will be placed incorrectly such as in the vertical position of knee and without any tension or traction around structures and patella. A computer will be used to generate the randomization sequence of the participants. The allocation will be printed in cards by sequentially numbered in opaque envelopes.
Before performing the exercises, a maximum voluntary isometric contraction will be performed for the knee extensor muscles (e.g. specifically the VMO and VL) and hip abductor muscles (e.g. GM) in order to normalize the signal EMG for determining of the level muscular activity during each exercise, with the correct taping and/or placebo. All participants, after randomization, will perform seven proprioceptive exercises on one leg-stance position in different surfaces: 1) static position in force platform, 2) dynamic in flexion-extension knee on a force platform, 3) anteroposterior sway on rectangular rocker board, 4) mediolateral sway on rectangular rocker board, 5) unipodal standing on a swing apparatus, 6) unipodal standing on a mini-trampoline, and 7) unipodal standing on bosu balance ball. Each exercise has a time of 15 seconds performance, while sway centre of pressure parameters will be computed (exercise #1 and #2), and EMG surface will recording (VMO, VL, GM) for all seven. First, one baseline measure (without taping) will be performed and immediately after with the use of taping (intervention or placebo).
An ANOVA two-way will be performed to compare the two groups (G1 and G2) and two times (before and immediately after with taping) and the effects of interaction (Groups x Times). The size effect also will be computed to determine the rate of the changes observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Taping | Experimental | Other: Intervention tapingThe experimental group will use a rigid patellar taping (G1, n = 22) for the correction of lateralization of the patella and stabilization of the knee. The lateral stabilization will be made with self-adhesive taping positioned in the lateral border of the patella and tensioned in relation to the medial portion of the femur condyle, which allows an edge of the medial board patella and a stretching of lateral structures of the knee. All procedure will follow the recommendation from McConnell studies with regard to the patellar femoral syndrome. |
| Placebo Taping | Placebo comparator | Other: Placebo TapingThe placebo group will use a rigid patellar taping (G2, n = 22), but without no correction of lateralization of the patella and/or stabilization of the knee. The taping will be placed incorrectly such as in the vertical position of knee and without any tension or traction around structures and patella. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- anterior or retropatellar knee pain on at least two of the following activities: prolonged sitting, stairs, squatting, running, kneeling, and hopping/jumping,
- pain on patellar palpation,
- pain while stepping down from a 25-cm step or during a double leg squat,
- symptoms for at least 1 month, average pain level of 3 cm or more on a 10-cm VAS.
Key exclusion criteria (5 listed)
- signs or symptoms of other pathology including coexisting pathology, a recent history (within 3 months) of knee surgery,
- history of patellar dislocation/subluxation, or clinical evidence of meniscal lesion, ligamentous instability, traction, apophysitis around the patellofemoral complex, patellar tendon pathology, chondral damage, osteoarthritis, or referred pain from the spine, features that could affect the implementation of the trial,
- previous experience with patellar taping, an inability to attend a physical therapy clinic for a 6-wk treatment program,
- allergic reaction to adhesive tape,
- pregnancy, and an inability to understand the experimental protocol.
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 |
|---|---|---|
| Intervention tapingAlso: Patellar tapingA rigid patellar taping will be used for the correction in lateralization of the patella and more stabilization of the knee. | Other | Intervention Taping |
| Placebo TapingAlso: Sham tapingA rigid patellar taping will be used in the vertical position and without no correction in lateralization of the patella and/or stabilization of the knee. | Other | Placebo Taping |
Primary outcome
Muscular activation level (EMG measures)
Time frame: Baseline and immediately after with the taping
Surface EMG signals will be record in the the vastus medialis oblique (VMO), vastus lateralis (VL) and gluteus medius (GM) muscles, before and immedialty after with taping, during seven proprioceptive exercises.
1 secondary outcome
Postural control measures (force platform)
Time frame: Baseline and immediately after with the taping
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 2015.
- Background: PubMed 12471291Cowan SM, Bennell KL, Crossley KM, Hodges PW, McConnell J. Physical therapy alters recruitment of the vasti in patellofemoral pain syndrome. Med Sci Sports Exerc. 2002 Dec;34(12):1879-85. doi: 10.1097/00005768-200212000-00004.
- Background: PubMed 25025219McCONNELL J. The management of chondromalacia patellae: a long term solution. Aust J Physiother. 1986;32(4):215-23. doi: 10.1016/S0004-9514(14)60654-1.
- Background: PubMed 24278879Lee SE, Cho SH. The effect of McConnell taping on vastus medialis and lateralis activity during squatting in adults with patellofemoral pain syndrome. J Exerc Rehabil. 2013 Apr;9(2):326-30. doi: 10.12965/jer.130018. Epub 2013 Apr 25.
- Derived from this study: PubMed 27693990Araujo CG, de Souza Guerino Macedo C, Ferreira D, Shigaki L, da Silva RA. Mcconnell's patellar taping does not alter knee and hip muscle activation differences during proprioceptive exercises: A randomized placebo-controlled trial in women with patellofemoral pain syndrome. J Electromyogr Kinesiol. 2016 Dec;31:72-80. doi: 10.1016/j.jelekin.2016.09.006. Epub 2016 Sep 21.
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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.
Rubens A DA SILVA, PhD principal investigator
Universidade Norte do Paraná
Questions about this trial
What is this clinical trial studying?
A study testing Intervention taping in people with Anterior Knee Pain Syndrome, run by Universidade Norte do Paraná.
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 4 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 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Muscular activation level (EMG measures) (time frame: Baseline and immediately after with the taping). 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 NCT02322515, 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 2 Dec 2015.