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Activation of Hip Muscles in Runners With Patellofemoral Syndrome

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ClinicalTrials.gov Identifier: NCT02837289
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Christiane Macedo, Universidade Estadual de Londrina

Tracking Information
First Submitted Date  ICMJE July 12, 2016
First Posted Date  ICMJE July 19, 2016
Last Update Posted Date December 2, 2017
Study Start Date  ICMJE July 1, 2016
Actual Primary Completion Date July 2, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
Changes in muscle activation by electromyography after treatment with therapy taping [ Time Frame: before and after 6 weeks of intervention ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Activation of Hip Muscles in Runners With Patellofemoral Syndrome
Official Title  ICMJE Activation of Hip Muscles in Runners With Patellofemoral Syndrome: Double-blind Randomized Clinical Trial
Brief 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). 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Patellofemoral Pain Syndrome
Intervention  ICMJE
  • Other: Therapy taping
    Therapy taping follows an anatomical pattern from the femur until tibia for correction of dynamic valgus with therapy taping.
  • Other: Placebo taping
    Placebo taping follows a different anatomical path without tension, eliminating all therapeutic process elements
Study Arms  ICMJE
  • Treatment
    Therapy taping follows an anatomical pattern from the femur until tibia for correction of dynamic valgus with therapy taping.
    Intervention: Other: Therapy taping
  • Placebo
    Placebo taping follows a different anatomical path without tension, eliminating all therapeutic process elements
    Intervention: Other: Placebo taping
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2016)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 3, 2017
Actual Primary Completion Date July 2, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Clinical diagnosis of patellofemoral dysfunction issued by a specialist orthopedic knee and provide anterior knee pain of 3 or more on the Visual Analogue Scale (VAS) for a minimum of 8 weeks prior to evaluation;

  • Previous retropatellar pain or knee, for at least 3 of the following: up / down stairs, squatting, running, kneeling, sitting for long periods and insidious onset of symptoms unrelated to trauma.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02837289
Other Study ID Numbers  ICMJE therapy taping in runners
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Christiane Macedo, Universidade Estadual de Londrina
Study Sponsor  ICMJE Universidade Estadual de Londrina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christiane Macedo, doctor Universidade Estadual de Londrina
PRS Account Universidade Estadual de Londrina
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP