Clinical trial NCT05108480: Self-myofascial Release With Foam Roller in Patients With Hemophilic Knee 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 Knee Arthropathy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Haemophilia
Lead sponsor: Investigación en Hemofilia y Fisioterapia
Sponsor class: NETWORK
First posted: 2021-11-05
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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 knee arthropathy and more than 3 points on the Hemophilia Joint Health Score.
* Being over 18 years old.
* No scheduled orthopedic surgeries during the study phase

Exclusion Criteria:

* Patients with hemarthrosis in the month before the beginning of the study.
* Patients unable to walk.
* Severe functional alterations of the upper limb that prevented the exercises.
* Failure to sign the informed consent document

Primary outcomes:
measure: Change from baseline knee joint pain after treatment and at 2 months
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up visit
Secondary outcomes:
measure: Change from baseline knee pressure pain threshold after treatment and at 2 months
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up visit
measure: Change from baseline knee joint status after treatment and at 2 months
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up visit
measure: Change from baseline knee range of motion after treatment and at 2 months
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up visit
measure: Change from baseline knee muscles strength after treatment and at 2 months
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up visit
measure: Change from baseline muscle flexibility after treatment and at 2 months
timeFrame: Screening visit, within the first seven days after treatment and after two months follow-up visit
measure: Change from baseline of muscle activation of the quadriceps after treatment and at 2 months
timeFrame: Screening visit, within the first seven days after treatment and after two 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: