Skip to main content
OpenTrials
Completed

NCT Number: NCT06281340

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hemophilia Arthralgia Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Oviedo

Oviedo, Principality of Asturias, 33006, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manual therapy

Other

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

Other

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.

Primary outcomes

  1. Change from baseline sonographic changes after 4 hours

    Time frame: Screening visit and after four hours follow-up

    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).

Secondary outcomes

  1. Change from baseline joint pain after 4 hours

    Time frame: Screening visit and after four hours follow-up

    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).

  2. Change from baseline joint damage after 4 hours

    Time frame: Screening visit and after four hours follow-up

    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).

  3. Change from baseline degree of joint inflammation after 4 hours

    Time frame: Screening visit and after four hours follow-up

    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

Sponsors and collaborators

Lead sponsor

Investigación en Hemofilia y Fisioterapia

Network

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 28, 2024
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.