Clinical trial NCT05606640: Gaining Insight Into the Complexity of Pain in Patients With Haemophilia
Official title: Gaining Insight Into the Complexity of Pain in Patients With Haemophilia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Hemophilia B
Keywords: Haemophilia
arthropathy
Pain
Biopsychosocial
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: University Hospital, Antwerp
First posted: 2022-11-07
Enrollment: 104
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult males with moderate or severe Haemophilia A or B will be recruited from the Haemophilia Treatment Centers in Antwerp (Antwerp University Hosptial) and Brussels (Cliniques universitaires Saint-Luc). Age-matched healthy control subjects will be recruited from family and acquintances of the researchers and hospital/university personnel.

Brief summary: Joint pain has been reported as a major problem in people with haemophilia (PwH). Therefore, haemophilia in adults seems clinically more related to a musculoskeletal disorder than a bleeding disorder, with many patients reporting a pain intensity exceeding 6/10 on a visual analogue scale. However, although the complexity of joint pain has been studied in chronic joint pain conditions such as low back pain, osteoarthritis or rheumatoid arthritis, until present only very limited research has been done on joint pain within PwH. Therefore, exploring the underlying mechanisms and the functional implications of this intense joint pain is urgently needed. As such, the main aim of the current prospective observational study is to gain more insights in joint pain in PwH enabling us to move towards adequate pain management in PwH.

Detailed description: In this study, adult patients with moderate or severe Haemophilia from the Haemophilia Treatment Centers will be invited to participate in the study. Patients willing to participate will be asked to complete a battery of questionnaires in the week prior to the study. Patients will undergo a comprehensive baseline evaluation after their regular appointment with their treating hematologist.

During the baseline assessment, the structure of ankle and knee joints will be assessed, using respectively magnetic resonance imaging (MRI) and ultrasound evaluation. Besides, patients will be asked to perform some active movements to quantify the physical functions of the lower limb and will undergo an extensive pain assessment.

During one month following baseline assessment, patients will be closely monitored. They will be asked to fill in a diary linked to their usual logbook in which they indicate the minimal and maximal intensity of pain, location of pain, intake of regular or additional (in case of bleeding) clotting factors, intake of analgesics, occurrence and location of assumed bleeding. Patients will be asked to wear an activity tracker to register the number of steps during this month.The short version of the International Physical Activity Questionnaire (IPAQ) will be used to evaluate the self-reported estimation of weekly physical activity.

During the next 11 months, patients will be asked to fill in three online pain-related questionnaires: the Brief Pain Inventory, Brief Illness Perception Questionnaire and the EQ-5D-5L questionnaire once a month.

Eligibility criteria: Inclusion Criteria:

* adult (18-65y) patients with moderate (i.e. between 1 and 5 % normal Factor activity) or severe (less than 1% normal Factor activity) Haemophilia A (i.e. Factor VIII deficiency) or B (i.e. Factor IX deficiency)
* Dutch or French speaking
* Patients who provide their haemophilia treatment regimen to be stable (i.e. a regular treatment during the last 6 months, verified by the existing patients' logbook).

Exclusion Criteria:

* Patients suffering from known neuropathies with definite medical causes independent from the haemophilia (e.g. diabetes polyneuropathy)
* Patients with a haemarthrosis in the month preceding study participation will be excluded as well. In case of doubt, ultrasound will be used to check the presence of bleed in the joint.

Primary outcomes:
measure: Pain localisation
timeFrame: At baseline (T0)
measure: Pain localisation
timeFrame: At one year follow-up (T2)
measure: Pain severity
timeFrame: At baseline (T0)
measure: Pain severity
timeFrame: At one year follow-up (T2)
measure: Pain interference
timeFrame: At baseline (T0)
measure: Pain interference
timeFrame: At one year follow-up (T2)
measure: Signs of neuropathic pain
timeFrame: At baseline (T0)
measure: Signs of central sensitization
timeFrame: At baseline (T0)
measure: Pain Catastrophizing
timeFrame: At baseline (T0)
measure: Anxiety and Depression
timeFrame: At baseline (T0)
measure: Fear Avoidance and Beliefs
timeFrame: At baseline (T0)
measure: Life quality
timeFrame: At baseline (T0)
measure: Life quality
timeFrame: At one year follow-up (T2)
measure: Haemophilia Activity Limitations
timeFrame: At baseline (T0)
measure: Physical endurance ability
timeFrame: At baseline (T0)
measure: Physical functioning
timeFrame: At baseline (T0)
measure: Joint structure US
timeFrame: At baseline (T0)
measure: Joint structure MRI
timeFrame: At baseline (T0)
measure: Illness perceptions
timeFrame: At baseline (T0)
measure: Illness perceptions
timeFrame: At one year follow-up (T2)
measure: Physical activity
timeFrame: At baseline (T0)
measure: Physical activity
timeFrame: At one month follow-up (T1)
measure: Joint function
timeFrame: At baseline (T0)
measure: Warm and cold detection threshold
timeFrame: At baseline (T0)
measure: Warm and cold pain thresholds
timeFrame: At baseline (T0)
measure: Mechanical pain thresholds
timeFrame: At baseline (T0)
measure: Temporal summation of pain
timeFrame: At baseline (T0)
measure: Conditioned Pain Modulation
timeFrame: At baseline (T0)
Secondary outcomes:
measure: Pain interference change
timeFrame: Change from baseline (T0) to one year follow-up (T2)
measure: Pain severity change
timeFrame: Change from baseline (T0) to one year follow-up (T2)
measure: Fear Avoidance and beliefs change
timeFrame: Change from baseline (T0) to one year follow-up (T2)
measure: Anxiety and Depression change
timeFrame: Change from baseline (T0) to one year follow-up (T2)
measure: Illness Perceptions change
timeFrame: Change from baseline (T0) to one year follow-up (T2)
measure: Pain Catastrophizing change
timeFrame: Change from baseline (T0) to one year follow-up (T2)
measure: Pain localisation change
timeFrame: Change from baseline (T0) to one year follow-up (T2)
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
city: Brussel
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Universiteit Antwerpen
name: Nathalie Roussel
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques universitaires Saint-Luc / UCLouvain
name: Cedric Hermans
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques universitaires Saint-Luc / UCLouvain
name: Catherine Lambert
role: PRINCIPAL_INVESTIGATOR
affiliation: Cliniques universitaires Saint-Luc / UCLouvain
name: Sébastien Lobet
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Antwerp
name: Philip Maes
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Antwerp - UCLouvain
name: Anthe Foubert
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Antwerp - UCLouvain
name: Valérie-Anne Chantrain
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiteit Antwerpen
name: Mira Meeus
role: PRINCIPAL_INVESTIGATOR
References: