Clinical trial NCT06281340: Changes in Intra-articular Parameters by Doppler Ultrasound in Patients With Hemophilic Ankle Arthropathy
Official title: Changes in Intra-articular Parameters by Doppler Ultrasound in Patients With Hemophilic Ankle Arthropathy After Manual Therapy Intervention: A Randomized Double-blind Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia
Keywords: Hemophilia
Ankle
Manual therapy
Ultrasound
Joint pain
Joint damage
Lead sponsor: Investigación en Hemofilia y Fisioterapia
Sponsor class: NETWORK
First posted: 2024-02-28
Enrollment: 20
Sex: MALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline sonographic changes after 4 hours
timeFrame: Screening visit and after four hours follow-up
Secondary outcomes:
measure: Change from baseline joint pain after 4 hours
timeFrame: Screening visit and after four hours follow-up
measure: Change from baseline joint damage after 4 hours
timeFrame: Screening visit and after four hours follow-up
measure: Change from baseline degree of joint inflammation after 4 hours
timeFrame: Screening visit and after four hours follow-up
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: University of Oviedo
state: Asturias
Study officials:
affiliation: Universidad de Oviedo
name: Rubén Cuesta-Barriuso, PhD
role: PRINCIPAL_INVESTIGATOR
References: