Effects of the Whole Body Vibration Application and Exercise in Patients With Patellofemoral Pain Syndrome: a Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Pain intensity
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Pain intensity
Time Frame: 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 Outcomes
- Knee range of movement(After treatment (Discharge, 4 weeks))
- Disability and functional assessment(After treatment (Discharge, 4 weeks))
Investigators
Sergio Hernandez Sanchez
Lecturer
Universidad Miguel Hernandez de Elche