Changes in Intra-articular Parameters by Doppler Ultrasound in Patients With Hemophilic Ankle Arthropathy

Investigación en Hemofilia y Fisioterapia

Status: Completed

Conditions: Hemophilia

Treatments: Other: Manual therapy; Other: Placebo manual therapy

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06281340

He-ankle US

Details and patient eligibility

About

Introduction: Hemophilic ankle arthropathy is manifested by functional degenerative alterations, intra-articular alterations, and chronic pain. Manual therapy techniques are used in the treatment of hemophilic ankle arthropathy for the improvement of pain and mobility.

Design. Double-blind randomized pilot trial. Aimed: To evaluate the ultrasound changes by means of Doppler imaging after manual therapy intervention.

Patients: A total of 20 adult patients with hemophilic ankle arthropathy will be recruited.

Intervention: Each manual therapy session will last approximately 50 minutes, with 1 session per week for a period of 3 weeks. The treatment program includes 10 techniques that will be administered bilaterally.

Measuring instruments: Patients will be evaluated qualitatively with ultrasound (HEAD-US scale) and assessment with Doppler ultrasound. The clinical variables will be joint damage (Hemophilia Joint Health Score) and pain intensity (Visual Analogue Scale).

Expected results: Check the safety of manual therapy in patients with hemophilia regarding subclinical bleeding. Assess changes related to joint inflammatory state with imaging techniques. Observe changes in pain intensity and joint damage.

Enrollment: 20 patients

Sex: Male

Ages: 30 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with hemophilia A or B.
• Persons over 18 years of age.
• Patients with a medical diagnosis of ankle arthropathy (with clinical assessment of more than 4 points on the Hemophilia Joint Health Score.
• Patients on prophylactic or on-demand treatment with FVIII / FIX concentrates.
• Sign the informed consent document.

Exclusion criteria

• Patients with inhibitors (antibodies against FVIII or FIX) without treatment with monoclonal antibodies.
• Patients with neurological or cognitive alterations that impede the comprehension of questionnaires and physical tests.
• Patients who have developed an ankle hemarthrosis in the 3 months prior to the study.
• Patients who at the time of the study are receiving ankle physiotherapy treatment.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

The patients included in the experimental group will receive a session of manual physiotherapy using joint gliding techniques, myofascial and manipulative techniques of the tobioperoneoastotalar and subtalar joints. The intervention will be performed on both ankles.

Treatment:

Other: Manual therapy

Control group

Placebo Comparator group

Description:

Patients included in the control group will receive a placebo manual physical therapy session, simulating joint sliding techniques, myofascial and manipulative techniques of the tobioperoneoastotalar and subtalar joints, without any stimulus other than the pressure exerted by the physical therapist with his hands when mobilizing the foot. The placebo intervention will be performed on both ankles.

Treatment:

Other: Placebo manual therapy