Patellofemoral Pain SyndromeNCT02827084
Effects of Kinesio Taping in Patellofemoral Pain
A study testing Kinesio Taping in people with Patellofemoral Pain Syndrome, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
The study aims to analyze the immediate effects and 72 hours after application of the Kinesio Taping (KT) in the electromyographic activity of the vastus medialis oblique (VMO) and vastus lateralis (VL), the isokinetic performance of the quadriceps and referred pain of subjects with PFPS. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Kinesio Taping
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteBrazil
- Study dates
- May 2016to Nov 2016
- 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
- Female between 18 and 35 years;
- BMI below 30;
- Clinical diagnosis- previous pain or retropatellar in at least two of the following functional activities: stay for a long time sitting, up or down stairs, run, kneel, crouch, jump;
- Onset of symptoms insidiously and nontraumatic;
- Pain intensity 3 or more on EVA;
- Presence of pain for at least 1 month;
Who cannot join
- Be performing currently physiotherapy;
- It present surgery, trauma or musculoskeletal system of the lower limb injury within 6 months;
- There have other pathologies associated with the knee joint;
- Does not run the tests properly;
- Does not attend all assessments.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Rio Grande do Norte
Natal, Rio Grande do Norte, 59140-840
Jamilson S Brasileiro, PhD, +55 84 3342-2008, brasileiro@ufrnet.br
About this study
Official title: Effects of Kinesio Taping in Painful and Neuromuscular Performance of Patients With Patellofemoral Pain
The study aims to analyze the immediate effects and 72 hours after application of the Kinesio Taping (KT) in the electromyographic activity of the vastus medialis oblique (VMO) and vastus lateralis (VL), the isokinetic performance of the quadriceps and referred pain of subjects with PFPS. The volunteers will be randomly assigned to one of the three groups and perform one of the protocols: control - remain at rest; KT - application of Kinesio Taping with tension in the VMO region; placebo - application of Kinesio Taping without tension, in the same region. All volunteers will be submitted to the evaluation of pain intensity, the electromyographic activity of the VMO and VL and dynamometric parameters in 3 times: before the application of KT, immediately after the application of KT and after 72h of application. Average effect estimates (differences between groups) for all variables will be calculated using the mixed model ANOVA with a significance level of 5% (p ≤ 0.05).
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Kinesio Taping, Placebo
- Keywords
- electromyography, torque, quadriceps muscle
- 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.
Kinesio TapingDevice
Also called Functional elastic tape
Application of the Kinesio Taping with tension in the vatus mediallis muscle.
PlaceboDevice
Also called Placebo functional elastic tape
Application of the Kinesio Taping without tension in the vatus mediallis muscle.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio Taping | Experimental | Apply the Kinesio Taping with tension in the vatus mediallis Receives: Device: Kinesio Taping |
| Placebo | Placebo comparator | Apply the Kinesio Taping without tension in the vatus mediallis Receives: Device: Placebo |
| Control | No intervention | It will not apply Kinesio. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of Electromyographic
Evaluation of onset electromyographic activity of Vastus Medialis Obliquus relative to Vastus Lateralis
Measured: Change from baseline in electromyographic at one hour and three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte
- Investigators
- Jamilson S Brasileiro, PhD, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827084
- Sponsor's protocol ID
- 20151012
- Status last verified
- Jul 2016
- First submitted
- 6 Jul 2016
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kinesio Taping in Painful and Neuromuscular Performance of Patients With Patellofemoral Pain
- ClinicalTrials.gov ID
- NCT02827084
- Acronym / sponsor ID
- 20151012
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- electromyography, torque, quadriceps muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 11 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.
The study aims to analyze the immediate effects and 72 hours after application of the Kinesio Taping (KT) in the electromyographic activity of the vastus medialis oblique (VMO) and vastus lateralis (VL), the isokinetic performance of the quadriceps and referred pain of subjects with PFPS. The volunteers will be randomly assigned to one of the three groups and perform one of the protocols: control - remain at rest; KT - application of Kinesio Taping with tension in the VMO region; placebo - application of Kinesio Taping without tension, in the same region. All volunteers will be submitted to the evaluation of pain intensity, the electromyographic activity of the VMO and VL and dynamometric parameters in 3 times: before the application of KT, immediately after the application of KT and after 72h of application. Average effect estimates (differences between groups) for all variables will be calculated using the mixed model ANOVA with a significance level of 5% (p ≤ 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kinesio Taping | Experimental | Device: Kinesio TapingApply the Kinesio Taping with tension in the vatus mediallis |
| Placebo | Placebo comparator | Device: PlaceboApply the Kinesio Taping without tension in the vatus mediallis |
| Control | No intervention | –It will not apply Kinesio. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female between 18 and 35 years;
- BMI below 30;
- Clinical diagnosis- previous pain or retropatellar in at least two of the following functional activities: stay for a long time sitting, up or down stairs, run, kneel, crouch, jump;
- Onset of symptoms insidiously and nontraumatic;
- Pain intensity 3 or more on EVA;
Key exclusion criteria (5 listed)
- Be performing currently physiotherapy;
- It present surgery, trauma or musculoskeletal system of the lower limb injury within 6 months;
- There have other pathologies associated with the knee joint;
- Does not run the tests properly;
- Does not attend all assessments.
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 |
|---|---|---|
| Kinesio TapingAlso: Functional elastic tapeApplication of the Kinesio Taping with tension in the vatus mediallis muscle. | Device | Kinesio Taping |
| PlaceboAlso: Placebo functional elastic tapeApplication of the Kinesio Taping without tension in the vatus mediallis muscle. | Device | Placebo |
Primary outcome
Onset of Electromyographic
Time frame: Change from baseline in electromyographic at one hour and three days
Evaluation of onset electromyographic activity of Vastus Medialis Obliquus relative to Vastus Lateralis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
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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.
Jamilson S Brasileiro, PhD principal investigator
Universidade Federal do Rio Grande do Norte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio Taping in people with Patellofemoral Pain Syndrome, run by Universidade Federal do Rio Grande do Norte 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 18 Jul 2016. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamison S Brasileiro, PhD (+ 55 84 3342-2015, brasileiro@ufrnet.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset of Electromyographic (time frame: Change from baseline in electromyographic at one hour and three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2016.