Clinical trial NCT04031248: Whole Body Vibration and Exercise in Knee Pain
Official title: Effects of the Whole Body Vibration Application and Exercise in Patients With Patellofemoral Pain Syndrome: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patello Femoral Syndrome
Keywords: knee
whole body vibration
therapeutic exercise
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: University of Seville
First posted: 2019-07-24
Enrollment: 30
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity
timeFrame: Baseline
measure: Pain intensity
timeFrame: After treatment (Discharge, 4 weeks)
Secondary outcomes:
measure: Knee range of movement
timeFrame: Baseline
measure: Knee range of movement
timeFrame: After treatment (Discharge, 4 weeks)
measure: Disability and functional assessment
timeFrame: Baseline
measure: Disability and functional assessment
timeFrame: After treatment (Discharge, 4 weeks)
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: A360 Heath and Sport Clinic
Study officials:
References:
citation: Yanez-Alvarez A, Bermudez-Pulgarin B, Hernandez-Sanchez S, Albornoz-Cabello M. Effects of exercise combined with whole body vibration in patients with patellofemoral pain syndrome: a randomised-controlled clinical trial. BMC Musculoskelet Disord. 2020 Aug 28;21(1):582. doi: 10.1186/s12891-020-03599-2.