Whole Body Vibration and Exercise in Knee Pain

• ClinicalTrials.gov Identifier: NCT04031248
• Recruitment Status: Completed
• First Posted: July 24, 2019
• Last Update Posted: November 3, 2020
• Sponsor: Universidad Miguel Hernandez de Elche
• Collaborator: University of Seville
• Information provided by (Responsible Party): Sergio Hernandez Sanchez, Universidad Miguel Hernandez de Elche

Tracking Information

• First Submitted Date: July 19, 2019
• First Posted Date: July 24, 2019
• Last Update Posted Date: November 3, 2020
• Actual Study Start Date: September 2, 2019
• Actual Primary Completion Date: October 14, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 23, 2019)

• Pain intensity [ Time Frame: Baseline ]
  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.
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 23, 2019)

• Knee range of movement [ Time Frame: Baseline ]
  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.
• Knee range of movement [ Time Frame: 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 [ Time Frame: Baseline ]
  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)
• Disability and functional assessment [ Time Frame: 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Patello Femoral Syndrome

Intervention

• Device: Whole body vibration
  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.
• Other: EXERCISE group
  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.

Study Arms

• Experimental: WBV group (experimental)

  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.

  Intervention: Device: Whole body vibration
• Active Comparator: Exercise group (control)
  Control subjects will perform the same exercise program without whole-body vibration.
  Intervention: Other: EXERCISE group

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 2, 2020): 30
• Original Estimated Enrollment (submitted: July 23, 2019): 46
• Actual Study Completion Date: November 30, 2019
• Actual Primary Completion Date: October 14, 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 40 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT04031248
• Other Study ID Numbers: 0916
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Sergio Hernandez Sanchez, Universidad Miguel Hernandez de Elche
• Original Responsible Party: Same as current
• Current Study Sponsor: Universidad Miguel Hernandez de Elche
• Original Study Sponsor: Same as current
• Collaborators: University of Seville
• Investigators: Not Provided
• PRS Account: Universidad Miguel Hernandez de Elche
• Verification Date: November 2020