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 range18 Years – 65 Years

SexMALE

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.

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)

Pain Catastrophizing

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 range18 Years – 65 Years

SexMALE

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)

Pain Catastrophizing

Timeframe: At baseline (T0)