An observational study in Hemophilia Arthropathy, sponsored by Investigación en Hemofilia y Fisioterapia. Completed at 1 site in Spain. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-02.
Sponsored by Investigación en Hemofilia y Fisioterapia · Observational
Background. The recurrence of hemarthrosis in patients with congenital coagulopathies favors the development of a progressive, degenerative and intra-articular lesion (hemophilic arthropathy) that mainly affects the knees, ankles and elbows. Pain is one of the main clinical manifestations of hemophilic arthropathy. As a consequence of the COVID-19 pandemic, the Government of Spain, among others, established a total confinement for two months, in order to avoid contagion of the population Objective. To assess the effect of COVID-19 confinement on bleeding frequency, pain perception, and range of motion in patients with hemophilic arthropathy.
Study design. Prospective observational study. Method. 27 patients with hemophilia A and B will be included in this study. Patients will be recruited from the Spanish Hemophilia Federation (Fishemo) specialized center for hemophilia patients. The dependent variables will be: the frequency of bleeding (through a self-report), the perception of pain (measured with the visual analog scale and a pressure algometer), the joint state (with the Hemophilia Joint Health Score), and the range of joint movement (measured with a goniometer). Two evaluations will be carried out: pre-treatment (carried out in the month of February, as a periodic evaluation) and post-treatment (at the end of the period of confinement in Spain).
Expected results. The aim is to observe the sequelae caused by confinement and a sedentary lifestyle in patients with hemophilic arthropathy, through changes in joint status, pain and range of motion.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 27 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
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Adult patients with hemophilic arthropathy routinely treated at the specialized hemophilia center of the Spanish Federation of Hemophilia (Fishemo).
Exclusion Criteria:
Hemophilic arthropathy patients who will not receive any intervention. The dependent variables (frequency of hemarthrosis, pain, joint state and range of movement) in the joints will be evaluated: elbows, knees and ankles.
Other: Observational
Hemophilic arthropathy patients who will not receive any intervention. The dependent variables (frequency of hemarthrosis, pain, joint state and range of movement) in the joints will be evaluated: elbows, knees and ankles.
Change from baseline frequency of hemarthrosis after confinement period
The frequency of joint bleeding was assessed using a self-assessment log provided to patients at the beginning of confinement electronically. This registry included a monthly calendar where the patients included the date, symptoms and location of the hemarthrosis.
Time frame: Screening visit, within the first seven days after confinement
Change from baseline joint health after confinement period
Joint status was assessed with the Hemophilia Joint Health Score (HJHS) version 2.1. This tool, specific for hemophilia patients, evaluates joint deterioration in the ankle, knee and elbow joints. This scale measures 8 items: swelling, duration of swelling, atrophy and muscle strength, crepitus, mobility and joint pain. The scoring range for this additive scale is 0-20 points at each joint.
Time frame: Screening visit, within the first seven days after confinement
Change from baseline joint pain after confinement period
Joint pain perception was measured with the visual analog scale. This scale has shown moderate reliability. The scoring range is from 0 to 10 points (from no pain to maximum perceived pain).
Time frame: Screening visit, within the first seven days after confinement
Change from baseline range of motion after confinement period
Range of motion was measured with a goniometer to assess flexion and extension of the elbow, knee, and ankle joints. This measuring instrument has shown good intra and inter-observer reliability in the joints evaluated. The measurement protocols described by Cleffken, Green and Gerhardt were used to measure mobility in the elbow, knee and ankle joints, respectively.
Time frame: Screening visit, within the first seven days after confinement
Change from baseline joint pain after confinement period
The pressure algometer measures the pressure, bilaterally, at which the patient perceives pressure pain on the evaluation point, as the pressure increases at a speed of approximately 50kPa / s. The unit of measurement is in Newton / cm2. The perception of joint pain in the elbow was measured on the lateral epicondyle, in the knee at a distance of 3 cm from the midpoint of the internal edge of the patella, and in the ankle it was measured in the ventral region of the lateral malleolus.
Time frame: Screening visit, within the first seven days after confinement
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Investigación en Hemofilia y Fisioterapia