Whole Body Vibration and Exercise in Knee Pain
- Conditions
- Patello Femoral Syndrome
- Interventions
- Other: EXERCISE groupDevice: Whole body vibration
- Registration Number
- NCT04031248
- Lead Sponsor
- Universidad Miguel Hernandez de Elche
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
- Adult patients with pain in the anterior aspect of the knee.
- Participants with a self-reported pain intensity ≥ 30 mm on the Visual Analogue Scale
- any contraindication for the use of training with whole-body vibration;
- to have received knee injections of corticosteroids or hyaluronic acid;
- cognition or impaired communication;
- to be involved in an ongoing medical-legal dispute.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise group (control) EXERCISE group Control subjects will perform the same exercise program without whole-body vibration. WBV group (experimental) Whole body vibration Participants in the experimental group will follow a program that 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.
- Primary Outcome Measures
Name Time Method Pain intensity After treatment (Discharge, 4 weeks) Visual Analog Scale (VAS). For the assessment of pain intensity during activity we will use an analogue scale of 10 centimeters, in which, 0 corresponds to "no pain" and 10 represents the "worst pain imaginable". The VAS of 10 centimeters is trusted and validated.
The questionnaire Douleur Neuropathique-4 items (DN4) (Bouhassira D, et al., 2005).
In order to assess neuropathic pain, we have used the Spanish validated version of the DN4 (Perez et al., 2007). This questionnaire consists of 10 items, consisting of descriptions and signs of pain that are evaluated with 1 (yes) or 0 (no) that indicate patients who have a high probability of having a neuropathic pain component. The evaluations of the individual items are added to obtain a maximum total score of 10, with a cut-off point ≥4.
- Secondary Outcome Measures
Name Time Method Knee range of movement After treatment (Discharge, 4 weeks) Goniometer (Norkin, 1997; Hancock et al., 2018). Knee flexion ROM measurement The individual was placed at dorsal decubitus, with 90 degrees of hip flexion. Hip positioning was guaranteed by the use of a thigh device which aided in the maintenance of the pre-set position. The universal goniometer was placed next to the femoral lateral epicondyle. The static handle of the goniometer was aligned with the thigh, having the femoral major trochanter as reference and the mobile handle aligned with the leg, with reference in the fibula lateral malleolus. The digital inclinometer was placed proximal and anteriorly on the leg, resting on the tibial crest.
Knee extension ROM measurement The individual was at dorsal decubitus, with extended legs. The evaluated limb was raised by the heel, with knee stabilization in contact with the stretcher. The instruments positioning in relation to the segment was the same of the measurements performed for knee flexion.Disability and functional assessment After treatment (Discharge, 4 weeks) Functional Scale of the Lower Extremity (LEFS). The Spanish version of this self-report questionnaire will be applied. This scale consists of 20 items with a score of 0 to 4, where the highest score represents the highest functionality of the lower limb (Cruz-Díaz et al., 2014, Binkley et al., 1999).
Kujala Patellofemoral Score. We will use the validated Spanish version of the validated questionnaire of 13 items, which designate a specific self-report of how each subject with patello.femoral pain perceives the function of the knee. Each item is based on six points where the highest scores represent a better functional capacity (Corum et al., 2018, Martínez-cano et al., 2017)
Trial Locations
- Locations (1)
A360 Heath and Sport Clinic
🇪🇸Sevilla, Spain