Fascial Therapy in Elbow Hemophilic Arthropathy (HeL-Fascial)

Real Fundación Victoria Eugenia

Status: Completed

Conditions: Hemophilia

Treatments: Other: Experimental group

Study type: Interventional

Funder types: Other

Identifiers

NCT03009591

HeL-Fascial

Details and patient eligibility

About

Introduction: The common clinical manifestations of hemophilia are skeletal muscle bleeds, especially hematomas and hemarthrosis. Repeated episodes of joint bleeding in certain joints, causing a progressive joint deterioration. Secondary disorders to this joint degeneration include: biomechanical alterations, loss of range of movement and periarticular muscle atrophy.

Design. A prospective, multicenter and longitudinal pilot study to evaluate the efficacy of a treatment protocol with fascial therapy applied in patients with hemophilic arthropathy of the elbow.

Aimed: To evaluate the safety and efficacy of a physiotherapy treatment by fascial therapy in patients with hemophilic arthropathy of the elbow Patients: A total of 60 patients with hemophilia and prophylactic treatment will be recruited for inclusion in the study. Patients will be recruited in 6 centers, from different regions of Spain.

Intervention: Each session will last approximately 50 minutes, with three physiotherapy sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers that must be administered bilaterally:

Measuring instruments and study variables: goniometric evaluation (range of movement); visual analog scale (joint pain); Haemophilia Joint Health Score (joint status); DASH Questionnaire (functionality of upper limbs); SF-36 Questionnaire (perception of quality of life). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment.

Expected results: First, it is intended to demonstrate the safety of this physiotherapy technique in patients with hemophilia. Likewise, an improvement in the perception of elbow pain and joint mobility is expected. An improved functionality of the upper limb is also foreseen and with it, an enhanced perception of quality of life of these patients.

Enrollment: 69 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with hemophilia A and B
• Patients adults (over 18 years)
• Patients diagnosed with hemophilic arthropathy of the elbow (by clinical assessment with the Hemophilia Joint Health Score)
• Patients pn prophylactic treatment with FVIII / FIX concentrates.

Exclusion criteria

• Patients without ambulation ability
• Patients with inhibitors
• Patients with neurological or cognitive alterations that impede the comprehension of the questionnaires and physical tests
• Patients who have not signed the informed consent document.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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69 participants in 2 patient groups

Expermiental group

Experimental group

Description:

All patients included in the experimental group should be on prophylactic treatment with FVIII / FIX concentrates. Likewise, the factor should be administered on the same day that they receive each of the fascial therapy treatment sessions. Each session will last approximately 50 minutes, with three physiotherapy sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers that must be administered bilaterally:

Treatment:

Other: Experimental group

Control group

No Intervention group

Description:

Subjects included in the control group will not receive physical therapy through fascial therapy and will continue with their usual routine of physical activity and exercise, and with the same pharmacological treatment regimen with FVIII / FIX. At the end of the study period the intervention will be applied under the same conditions as the experimental group, analyzing the overall sample at the end of the study.