Maintenance Notice

Due to necessary scheduled maintenance, the JMIR Publications website will be unavailable from Monday, March 11, 2019 at 4:00 PM to 4:30 PM EST. We apologize in advance for any inconvenience this may cause you.

Who will be affected?

Advertisement

Currently submitted to: JMIR Research Protocols

Date Submitted: Jul 29, 2019
Open Peer Review Period: Aug 2, 2019 - Sep 27, 2019
(currently open for review)

Prospective and multicenter study to assess the safety and effectiveness of a physiotherapy treatment through self-myofascial release with Foam Roller in patients with hemophilic ankle arthropathy. A randomized clinical trial.

  • Rubén Cuesta-Barriuso; 
  • Javier Meroño-Gallut Sr; 
  • Raúl Pérez-Llanes Sr; 
  • Elena Donoso-Úbeda; 

ABSTRACT

Background:

Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscle strength, mobility and proprioception) (intra-articular alterations) and chronic pain. Myofascial release techniques are used to treat soft tissue adhesions, relieve pain and reduce tissue sensitivity.

Objective:

To evaluate the safety and effectiveness of a protocol by self-myofascial release with Foam Roller applied in patients with hemophilic ankle arthropathy.

Methods:

70 patients with ankle arthropathy will be recruited for inclusion in the study. Patients will be recruited in 5 centers, from different regions of Spain.Each session will last approximately 15 minutes, with five physiotherapy sessions per week for a period of 3 months. Patients will be evaluated at baseline, after the intervention, and after a follow-up period of 3 months. The treatment program includes 11 exercises that must be administered bilaterally. A mobile application will be developed where each patient will be able to observe the exercises to be carried out. Measuring instruments and study variables: digital goniometer (ankle range of motion); visual analog scale and pressure algometer (joint pain); Haemophilia Joint Health Score (joint status); dynamometer assess (muscle strength); 6-Minute Walking test (functionality of lower limbs); Mobile device (Activity record); Finger-floor test (muscle flexibility). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment.

Results:

Expected results: To demonstrate the safety of this Physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, functionality and joint motion is expected.

Conclusions:

To demonstrate the safety of this Physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, functionality and joint motion is expected. Clinical Trial: The protocol and its subsequent randomized clinical study were approved by the Research Ethics Committee of the University of Murcia (ID: 2428/2019). The project was registered with the American Clinical Registry for clinical trials with patients (ClinicalTrials.gov ID: NCT03914287). Likewise, pending the updating of the SAS / 3470 / 2009 law of the National Registry of the Spanish Agency of Medicines and other Sanitary Products (AEMPS) through the draft Royal Decree of Clinical Trials in the process of approval, was approved as an Non-observational study without medication.


 Citation

Please cite as:

Cuesta-Barriuso R, Meroño-Gallut J Sr, Pérez-Llanes R Sr, Donoso-Úbeda E

Prospective and multicenter study to assess the safety and effectiveness of a physiotherapy treatment through self-myofascial release with Foam Roller in patients with hemophilic ankle arthropathy. A randomized clinical trial.

JMIR Preprints. 29/07/2019:15612

DOI: 10.2196/preprints.15612

URL: https://preprints.jmir.org/preprint/15612


Request queued. Please wait while the file is being generated. It may take some time.

© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.