NCT05606640

Gaining Insight Into the Complexity of Pain in Patients With Haemophilia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 104 (actual)
• Sponsor: Universiteit Antwerpen · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hemophilia A
• Hemophilia B

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Biopsychological pain assessment	At baseline (T0) patients underwent the somatosensory pain assessment, joint structure and function assessment and filled in all questionnaires. During one month after baseline (T1) patients wore an activity tracker and filled in the Illness Perceptions Questionnaire and the International Physical Activity questionnaire. During one year after the baseline assessment (T2) patients filled in every month The Brief Pain Inventory, Illness Perceptions Questionnaire and the EQ-5D-5L quality of life questionnaire.

Timeline

• Start date: 2020-02-13
• Primary completion: 2023-02-28
• Completion: 2023-10-13
• First posted: 2022-11-07
• Last updated: 2024-05-31

Locations

2 sites across 1 country: Belgium