CompletedNot Applicable

Gaining Insight Into the Complexity of Pain in Patients With Haemophilia

Belgium104 participantsStarted 2020-02-13

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain localisation

Timeframe: At baseline (T0)

Pain localisation

Timeframe: At one year follow-up (T2)

Pain severity

Timeframe: At baseline (T0)

Pain severity

Timeframe: At one year follow-up (T2)

Pain interference

Timeframe: At baseline (T0)

Pain interference

Timeframe: At one year follow-up (T2)

Signs of neuropathic pain

Timeframe: At baseline (T0)

Signs of central sensitization

Timeframe: At baseline (T0)

Trial details

NCT IDNCT05606640

SponsorUniversiteit Antwerpen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-02-28

View on ClinicalTrials.gov More Hemophilia A trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Pain localisation

Timeframe: At baseline (T0)

Pain localisation

Timeframe: At one year follow-up (T2)

Pain severity

Timeframe: At baseline (T0)

Pain severity

Timeframe: At one year follow-up (T2)

Pain interference

Timeframe: At baseline (T0)

Pain interference

Timeframe: At one year follow-up (T2)

Signs of neuropathic pain

Timeframe: At baseline (T0)

Signs of central sensitization

Timeframe: At baseline (T0)