NCT06281340Completed
Changes in Intra-articular Parameters by Doppler Ultrasound in Patients With Hemophilic Ankle Arthropathy
Changes in Intra-articular Parameters by Doppler Ultrasound in Patients With Hemophilic Ankle Arthropathy After Manual Therapy Intervention: A Randomized Double-blind Clinical Study
Source: ClinicalTrials.gov · Last updated 24 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 20 Feb 2024
- Start date
- 28 Feb 2024
- Primary completion date
- 10 Apr 2024
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Diseases
- Haemophilia
- NCT number
- NCT06281340
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 28 Feb 2024 to the primary completion date, 10 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with inhibitors (antibodies against FVIII or FIX) without treatment with monoclonal antibodies.
- 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.
Other
- Patients with neurological or cognitive alterations that impede the comprehension of questionnaires and physical tests.
Who the study is looking for
- 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.
Age in the registry: 30 years to 55 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Oviedo Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.