Whole Body Vibration and Exercise in Knee Pain

NCT04031248 | Completed

• 1 other identifier: 0916
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Patello Femoral Syndrome

Keywords

knee; whole body vibration; therapeutic exercise

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  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.

  Baseline

• Pain intensity

  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.

  After treatment (Discharge, 4 weeks)

Secondary Outcomes (4)

• Knee range of movement

  Baseline

• Knee range of movement

  After treatment (Discharge, 4 weeks)

• Disability and functional assessment

  Baseline

• Disability and functional assessment

  After treatment (Discharge, 4 weeks)

Study Arms (2)

WBV group (experimental)

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.

Device: Whole body vibration

Exercise group (control)

ACTIVE COMPARATOR

Control subjects will perform the same exercise program without whole-body vibration.

Other: EXERCISE group

Interventions

Whole body vibration DEVICE

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.

WBV group (experimental)

EXERCISE group OTHER

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.

Exercise group (control)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead
• University of Seville: collaborator

Study Sites (1)

A360 Heath and Sport Clinic

Seville, Spain

Location

Related Publications (1)

• 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.

  PMID: 32859183 DERIVED

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 24, 2019
• Study Start: September 2, 2019
• Primary Completion: October 14, 2019
• Study Completion: November 30, 2019
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)