Gaining Insight Into the Complexity of Pain in Patients With Haemophilia

NCT ID: NCT05606640

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-13
• Study Completion Date: 2023-10-13

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.

Conditions

Hemophilia A; Hemophilia B

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Haemophilia

Adult males with severe or moderate haemophilia A or B

Biopsychological pain assessment

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Pain-related questionnaires: Brief Pain Inventory, Douleur Neuropathique en 4 questions, Central Sensitization Inventory; Psychological questionnaires: Pain Catastrophizing Scale, Hospital Anxiety and Depression Scale, Fear Avoidance and Beliefs Questionnaire, The EuroQol-5 (EQ-5D-5L) quality of life questionnaire; Functional questionnaires: Haemophilia Activity List, International Physical Activity Questionnaire (IPAQ); Joint structure: Magnetic Reasoning Imaging (MRI) ankles & ultrasound evaluation of affected joints; Joint function: Hemophilia Joint Health Score (HJHS 2.1), Timed Up & Go, 2 minutes walking test, activity tracker; Somatosensory pain assessment: Quantitative Sensory testing protocol, Conditioned Pain Modulation protocol

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: collaborator

Universiteit Antwerpen

OTHER

Sponsor Role: lead

Responsible Party

Prof. dr. Mira Meeús

Professor Rehabilitation Sciences and Physiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathalie Roussel

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Cedric Hermans

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc / UCLouvain

Catherine Lambert

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc / UCLouvain

Sébastien Lobet

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc / UCLouvain

Philip Maes

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Anthe Foubert

Role: PRINCIPAL_INVESTIGATOR

University of Antwerp - UCLouvain

Valérie-Anne Chantrain

Role: PRINCIPAL_INVESTIGATOR

University of Antwerp - UCLouvain

Mira Meeus

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Locations

University Hospital Antwerp

Edegem, Antwerp, Belgium

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Countries

Belgium

Other Identifiers

2019/28OCT/469

Identifier Type: OTHER

Identifier Source: secondary_id

B300201942304

Identifier Type: OTHER

Identifier Source: secondary_id

19/43/483

Identifier Type: OTHER

Identifier Source: secondary_id

EDGE000540

Identifier Type: OTHER

Identifier Source: secondary_id

PAINSTUDY_2019

Identifier Type: -

Identifier Source: org_study_id