Clinical trial NCT05104164: Self-myofascial Release in Hemophilic Ankle Arthropathy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia
Keywords: Hemophilic arthropathy
Ankle
Self-myofascial release
Safety
Joint pain
Functionality
Lead sponsor: Investigación en Hemofilia y Fisioterapia
Sponsor class: NETWORK
First posted: 2021-11-02
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Introduction: 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.

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

Patients: 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.

Intervention: 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.

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.


Eligibility criteria: Inclusion Criteria:

* Being over 18 years old
* Patients with a medical diagnosis of hemophilia A or B.
* Patients with a severe phenotype of hemophilia (\<1% FVIII/FIX).
* Patients with a medical diagnosis of hemophilic ankle arthropathy and more than 3 points on the Hemophilia Joint Health Score.
* Nno scheduled orthopedic surgeries during the study phase.
* Signing the informed consent document.

Exclusion Criteria:

* Patients with ankle hemarthrosis in the month before the beginning of the study.
* Patients unable to walk even with technical aids.
* Patients with hemophilic elbow arthropathy that prevented the performance of the exercises.

  * Patients failing to complete at least 80% of the sessions scheduled in the intervention

Primary outcomes:
measure: Change from baseline ankle bleeding after treatment and at 3 months
timeFrame: Screening visit, within the first seven days after treatment and after three months follow-up visit
Secondary outcomes:
measure: Change from baseline ankle pain after treatment and at 3 months
timeFrame: Screening visit, within the first seven days after treatment and after three months follow-up visit
measure: Change from baseline range of ankle motion after treatment and at 3 months
timeFrame: Screening visit, within the first seven days after treatment and after three months follow-up visit
measure: Change from baseline functional capacity after treatment and at 3 months
timeFrame: Screening visit, within the first seven days after treatment and after three months follow-up visit
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: University of Murcia
Study officials:
affiliation: Universidad de Murcia
name: Rubén Cuesta-Barriuso, PhD
role: PRINCIPAL_INVESTIGATOR
References: