Whole Body Vibration and Exercise in Knee Pain
Condition: Patello Femoral Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome
Study type: Interventional

Summary: 
      The present study will consist of evaluating the effect of applying an exercise protocol on a
      vibratory platform in order to provoke immediate influences in the affected systems and in
      the quality of life of the patients with patella-femoral pain.
    

Detailed description: 
      Knee pain is a common condition with a high prevalence in the general population, being
      femoro-patellar pain one of the most common forms of knee pain (Crossley et al., 2016a). Its
      incidence ranges between 5.1% and 14.9% and its prevalence is between 16.3% and 28.9% in
      adolescents (Smith et al., 2018). Femoro-patellar pain is described as diffuse pain in the
      anterior area of the knee not caused by a traumatic action, which is aggravated when
      performing squats, running, going up and down stairs or sitting for a long time The
      recommended conservative treatment for this condition according to the 2016 Manchester and
      Australia 2017consensus is the therapeutic exercise, combining knee and hip exercises
      (Crossley et al., 2016b), mainly quadriceps and gluteus medius (Collins et al., 2018).

      INTERVENTION All participants will be assessed at baseline and at the end of treatment
      (discharge) by a blinded investigator.

      The program will consist of a routine of 18 exercises that will be executed where the
      greatest neuromuscular recruitment is sought. Most exercises are dynamic and isotonic. It is
      structured following the scheduled phases (ACSM, 2013) of warm-up, development and return to
      calm or stretching. The total duration of the program is 22 minutes, keeping the general
      lines of high-intensity aerobic interval training, which establishes a rest period at least
      equal to that of work.

      The treatment protocol will consist of 11 sessions applied in 4 weeks under an intervention
      regime of weeks 3 sessions, with a duration per session of 22 minutes, which will be
      supervised by a physiotherapist with more than 15 years of clinical experience.

      The experimental group will develop the exercise program on the whole body vibration
      platform, and control group on the switched-off vibration device (without any vibration
      stimuli)

      DESIGN AND STATISTICS

      This study will be a randomized clinical trial with a control group. It will consider an
      alpha or type I error of 95% and a beta or type II error of 80%, with a hypothesis to a tail.
      The randomized controlled trial will be performed with a single-blind (the evaluator who
      evaluated the outcome measures remained blinded to the participants' allocation group). The
      sample will be randomly selected through the randomized.com program among the patients that
      meet the inclusion criteria that we will be described later. Participants will be distributed
      equally between the control group and the experimental group.

      The research protocol will be carried out in accordance with the Declaration of Helsinki
      statement of ethics, legal and regulatory principles to provide guidance for research related
      to health in humans. The CONSORT guidelines have been the reference to design the Project,
      the ad will be used to make the final report.
    

Intervention name(s): Whole body vibration; EXERCISE group
Intervention type(s): Device; Other
Intervention description(s): In this study an axial vibratory platform will be used: POWER-PLATE pro 5 AIRdaptive TM HP®. This device is reviewed annually by the technical unit of the company itself and complies with the international regulations that regulate the Medical Devices [Devices Directive (MDD) 93/42 / EEC (ISO 2631. 2011, Powerplate.com, 2013)]. The vibration will be administered with 2 mm of amplitude and 40 Hz of frequency.; The program will consist of a routine of 18 exercises that will be executed where the greatest neuromuscular recruitment is sought. Most exercises are dynamic and isotonic. It is structured following the scheduled phases (ACSM, 2013) of warm-up, development and return to calm or stretching. The total duration of the program is 22 minutes, keeping the general lines of high-intensity aerobic interval training, which establishes a rest period at least equal to that of work. The treatment protocol will consist of 11 sessions applied in 4 weeks under an intervention regime of weeks 3 sessions, with a duration per session of 22 minutes, which will be supervised by a physiotherapist with more than 15 years of clinical experience.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee; whole body vibration; therapeutic exercise