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

Hemophilia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06281340
• Other study ID #: He-ankle US
• Status: Completed
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: April 21, 2024

Study information

• Verified date: May 2024
• Source: Investigación en Hemofilia y Fisioterapia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 21, 2024
• Est. primary completion date: April 10, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A
• Joint Diseases

Intervention

Other:
• Manual therapy
Each session will last approximately 50-60 minutes. Each session is composed of 10 techniques, 9 of which correspond to manual interventions commonly used in the field of manual therapy and adapted to patients with hemophilic arthropathy, according to the criteria previously established in studies that assess the safety of manual interventions in hemophilic arthropathy.
• Placebo manual therapy
Each session will last approximately 50-60 minutes. Each session consists of the placebo application of 10 techniques, 9 of which correspond to manual interventions commonly used in the field of manual therapy and adapted to patients with hemophilic arthropathy, according to criteria previously established in studies that assess the safety of manual interventions in hemophilic arthropathy. In the techniques there will be no joint sliding, manipulations or myofascial inductions, being the only stimulus the contact of the physiotherapist with his hands and the pressure exerted with these, on the ankle.

Locations

Country	Name	City	State
Spain	University of Oviedo	Oviedo	Asturias

Sponsors (1)

Lead Sponsor	Collaborator
Investigación en Hemofilia y Fisioterapia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline sonographic changes after 4 hours	Ultrasound changes will be measured with the Haemophilia Early Arthropathy Detection with UltraSound score. This scale evaluates two parameters: i) inflammatory activity (scores synovial hypertrophy from 0 to 2 points depending on whether involvement is identified); and ii) involvement of articular surfaces (assesses articular cartilage and bone involvement). In the assessment of articular cartilage, a score from 0 to 4 is established (0: normal; 4: complete destruction of cartilage or cannot be visualized). Bone is scored from 0 to 2 points (0: normal; 2: involvement with osteophytes).	Screening visit and after four hours follow-up
Secondary	Change from baseline joint pain after 4 hours	The intensity of ankle joint pain will be measured with the visual analog scale. This scale has shown moderate reliability (ICC: 0.60-0.77) in patients with chronic musculoskeletal pain. Its scores range from 0 to 10 points (from no pain to the maximum pain perceived by the patient).	Screening visit and after four hours follow-up
Secondary	Change from baseline joint damage after 4 hours	Joint damage will be measured with the Hemophilia Joint Health Score (HJHS). This measurement instrument will be used to assess the joint status of both ankles. It includes 8 items (swelling and duration of swelling, pain, muscle atrophy and strength, crepitus, and loss of flexion and extension) with a range of 0 to 20 points per joint (the higher the score, the greater the joint impairment).	Screening visit and after four hours follow-up
Secondary	Change from baseline degree of joint inflammation after 4 hours	With a doppler assessment, a qualitative assessment of the degree of joint inflammation (semi-quantitative visual scale from 1 to 4: none, mild, moderate, severe) and a quantitative assessment by quantifying the resistance index (RI) will be performed	Screening visit and after four hours follow-up