NCT05108480

Self-myofascial Release With Foam Roller in Patients With Hemophilic Knee Arthropathy

Completed NA Last updated 3 March 2022

What this trial tests

NA trial testing Experimental group in Haemophilia in 56 participants. Completed in 17 February 2022.

Timeline

26 October 2021

Primary endpoint
17 February 2022

17 February 2022

Quick facts

Lead sponsor	Investigación en Hemofilia y Fisioterapia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	56
Start date	26 October 2021
Primary completion	17 February 2022
Estimated completion	17 February 2022
Sites	1 location across Spain

Drugs / interventions tested

• Experimental group

Conditions studied

• Haemophilia — all drugs for Haemophilia →

Sponsor

Investigación en Hemofilia y Fisioterapia

Who can join

Adults 18 to 65, male only, with Haemophilia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscular 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.

Design. A randomized clinical trial. Directed: To evaluate the safety and effectiveness of a myofascial self-release protocol with Foam Roller applied in patients with hemophilic knee arthropathy.

Patients: 58 patients with knee arthropathy will be recruited for inclusion in the study. The patients will be recruited in 5 centers, from different regions of Spain.

Intervention: Each session will last approximately 15 minutes, with five physical therapy sessions per week over a period of 8 weeks. Patients will be evaluated at the beginning of the study, after the intervention and after a follow-up period of 2 months. The treatment program includes 11 exercises to be administered bilaterally. A mobile application will be developed where each patient can observe the exercises to be performed.

Measurement instruments and study variables: digital goniometer (ankle range of motion); visual analog scale and pressure algometer (joint pain); Hemophilia Joint Health Score (Joint Condition); dynamometer evaluation (muscle strength); 6-minute walk test (lower extremity functionality); Mobile device (activity log); Finger floor test (muscle flexibility). At the same time, the study will make it possible to determine the joint bleeding caused by the applied physiotherapy treatment.

Expected results: demonstrate the safety of this physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, function and joint movement is expected.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Foam roller-based self-induced myofascial therapy in patients with hemophilic knee arthropathy: a multicenter, single-blind, randomized clinical study.
   Donoso-Úbeda E, Pérez-Llanes R, Meroño-Gallut J, Ucero-Lozano R, et al · · 2023 · cited 1× · PMID 37869759 · DOI 10.23736/s1973-9087.23.07944-3