Hemophilia ANCT05606640
Gaining Insight Into the Complexity of Pain in Patients With Haemophilia
An observational study of Hemophilia A and Hemophilia B, run by Universiteit Antwerpen at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hemophilia A, Hemophilia B
- What is being tested?
- Biopsychological pain assessment
- How many people
- 104 participants
- Where
- 2 sitesBelgium
- Study dates
- 13 Feb 2020to 13 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Cliniques universitaires Saint-Luc
Brussels, 120
University Hospital Antwerp
Edegem, Antwerp, 2650
About this study
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.
Read the 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
- Being tested
- Biopsychological pain assessment
- Keywords
- Haemophilia, arthropathy, Pain, Biopsychosocial
- Medical subject headings
- Hemophilia A, Hemophilia B, Joint Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsychological pain assessmentDiagnostic test
Also called 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
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.
| Study group | Role | What they receive |
|---|---|---|
| Haemophilia | Adult males with severe or moderate haemophilia A or B Receives: Diagnostic Test: Biopsychological pain assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain localisation
The body chart of the Brief Pain Inventory (BPI) was used to investigate painful body sites.
Measured: At baseline (T0)
Pain localisation
The body chart of the Brief Pain Inventory (BPI) was used to investigate painful body sites.
Measured: At one year follow-up (T2)
Pain severity
The BPI was used to evaluate the individual's pain experience within the last 24 hours by four items, resulting in a total pain severity score. Minimum score 0, maximum score 10. The higher te score, the higher the pain severity.
Measured: At baseline (T0)
Pain severity
The BPI was used to evaluate the individual's pain experience within the last 24 hours by four items, resulting in a total pain severity score. Minimum score 0, maximum score 10. The higher te score, the higher the pain severity.
Measured: At one year follow-up (T2)
Pain interference
The BPI was used to evaluate how much pain interferes with patient's daily activities. This was assessed by seven items, resulting in a total pain interference score. Minimum score 0, maximum score 10. The higher the score, the more pain interference.
Measured: At baseline (T0)
Pain interference
The BPI was used to evaluate how much pain interferes with patient's daily activities. This was assessed by seven items, resulting in a total pain interference score. Minimum score 0, maximum score 10. The higher the score, the more pain interference.
Measured: At one year follow-up (T2)
Signs of neuropathic pain
The Douleur Neuropathique en 4 questions (DN4) was applied as a screening tool for the presence of a neuropathic pain component. Minimum score 0, maximum score 10, a score of ≥4/10 was used as a cut-off.
Measured: At baseline (T0)
Signs of central sensitization
The Central Sensitisation Inventory (CSI) part A was used to identify signs of central sensitization (CS) i.e. increased sensitivity of nociceptive neurons in the central nervous system.The presence of 25 pain-related psychological, cognitive and functional signs are scored from 0 (never) to 4 (always). A total score exceeding ≥40/100 indicated central sensitization.
Measured: At baseline (T0)
Pain Catastrophizing
The Pain Catastrophizing Scale (PCS) asked participants to reflect on previous painful experiences and to rate their degree of catastrophic thinking in the content domains of rumination, magnification and helplessness. A score of 0 (not at all) to 4 (all the time) was indicated for each of the 13 items, resulting in a total score range of 0-52. Higher scores were associated with higher levels of pain catastrophizing.
Measured: At baseline (T0)
Anxiety and Depression
The Hospital Anxiety and Depression Scale (HADS) was used to establish symptoms of anxiety and depression. This 14-item questionnaire consists of two subscales each including 7 items, the first to identify anxiety and the second depression. Individual items were scored from 0 to 3, resulting in a total range score of 0-21 for each subscale. A score of ≥8/21 was determined as a cut-off, indicating anxiety and depression.
Measured: At baseline (T0)
Fear Avoidance and Beliefs
The fear avoidance and beliefs questionnaire (FABQ) will be used to assess fear avoidance behaviors. The first five items question physical activity, the other 11 activities work. A minimum score is 0, maximum 24. Higher scores indicate fear avoidance behaviors.
Measured: At baseline (T0)
Life quality
The EQ-5D-5L was used to assess quality of life. From five items investigating the impact of their disease, a health utility score was calculated. Additionally, the questionnaire consists of a visual analogue scale (VAS) labelled from 0: "worst imaginable health state," to 100 "best imaginable health state" providing the EQ-VAS.
Measured: At baseline (T0)
Life quality
The EQ-5D-5L was used to assess quality of life. From five items investigating the impact of their disease, a health utility score was calculated. Additionally, the questionnaire consists of a visual analogue scale (VAS) labelled from 0: "worst imaginable health state," to 100 "best imaginable health state" providing the EQ-VAS.
Measured: At one year follow-up (T2)
Haemophilia Activity Limitations
The Haemophilia Activity List (HAL) was used to assess activity limitations and participation restrictions people with haemophilia suffer with. A sum score and component scores can be calculated, resulting in scores ranging from 0-100. Lower scores represent higher levels of participation restrictions.
Measured: At baseline (T0)
Physical endurance ability
The 2 minutes walking test (2MWT) was used as a performance-based test to assess their functional activity. Subjects were asked to walk as far as possible for two minutes in a 30 meters flat corridor, resulting in the walking distance in meters.
Measured: At baseline (T0)
Physical functioning
The Timed Up \& Go (TUG) consists of asking the patient to sit on a standard armchair; stand up and walk 3 meters; turn around at the line and walk back to the chair and sit down at a normal pace.
Measured: At baseline (T0)
Joint structure US
Ultrasound (US) examinations will be performed with a linear probe (3-13 MHz) Esaote, type MyLab Gamma, Genova, Italy).The Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) scanning procedure and scoring method will be performed by one of our investigators. A score of 0/8 (normal bone 0/2, normal cartilage 0/4, absent hypertrophic synovium 0/2) is considered normal. A score above 1/8 is considered as abnormal.
Measured: At baseline (T0)
Joint structure MRI
Magnetic Reasoning Imaging (MRI) of the ankles will be performed with a 3T-magnet (GE Signa Premier, GE Healthcare, Milwaukee, USA).Joint images will be classified with the international Prophylaxis Study Group (IPSG) scale. Joints will be classified as abnormal if talocrural joints or subtalar joints were positive at IPSG-score. Joints will be considered healthy if the total score was of 1/17.
Measured: At baseline (T0)
Illness perceptions
The illness perceptions questionnaire (B-IPQ) includes nine items ranging from 0 (minimum) to 10 (maximum) and questions the perceptions related to the patients disease. No total score exists, as each item is scored individually. Higher scores indicate more negative or unhelpful illness perceptions. A change score between baseline (T0) and one year follow-up (T2) will be calculated.
Measured: At baseline (T0)
Illness perceptions
The illness perceptions questionnaire (B-IPQ) includes nine items ranging from 0 (minimum) to 10 (maximum) and questions the perceptions related to the patients disease. No total score exists, as each item is scored individually. Higher scores indicate more negative or unhelpful illness perceptions. A change score between baseline (T0) and one year follow-up (T2) will be calculated.
Measured: At one year follow-up (T2)
Physical activity
The International Physical Activity Scale (IPAQ) questions the hours of physical activity over the last week (Higher scores are higher levels of physical activity). Based on the patient's answers a MET-minute score is calculated (MET-minutes x weight in kilograms/60kilograms)
Measured: At baseline (T0)
Physical activity
The International Physical Activity Scale (IPAQ) questions the hours of physical activity over the last week. Based on the patient's answers a MET-minute score is calculated (MET-minutes x weight in kilograms/60kilograms)
Measured: At one month follow-up (T1)
Joint function
Joint function of the ankles, knees and ankles was assessed with the HJHS 2.1. Minimum score is 0, maximum, 20. The higher the score the more functional limitations. HJHS scores are considered positive when scores reach 1/20.
Measured: At baseline (T0)
Warm and cold detection threshold
Thermal hyper or hypo esthesia were assessed with a thermode attached at the dominant wrist by use of a validated Quantitative Sensory testing protocol with the Medoc TSA-2 device.
Measured: At baseline (T0)
Warm and cold pain thresholds
Thermal hyper or hypo algesia were assessed with a thermode attached at the dominant wrist by use of a validated Quantitative Sensory testing protocol with the Medoc TSA-2 device.
Measured: At baseline (T0)
Mechanical pain thresholds
Mechanical local and widespread hyperalgesia indicated by lower pressure pain thresholds were assessed with a digital algometer at the knee joints, ankle joints and forehead. This by use of a validated quantitative sensory testing protocol.
Measured: At baseline (T0)
Temporal summation of pain
Temporal summation (or bottom-up sensitization) of pain was assessed by use of a 60g Von Frey monofilament at the medial knee and dorsal side of the wrist of the dominant side.
Measured: At baseline (T0)
Conditioned Pain Modulation
Dysfunctional endogenous pain inhibition (as form of central pain processing) was assessed by a validated protocol applying the Medoc TSA-2 device with thermodes attached at both wrists.
Measured: At baseline (T0)
Secondary outcomes (7)
Pain interference change
The BPI was used to evaluate how much pain interferes with patient's daily activities. This was assessed by seven items, resulting in a total pain interference score. Minimum score 0, maximum score 10. The higher the score, the more pain interference.A change score between baseline and one year follow-up will be calculated.
Measured: Change from baseline (T0) to one year follow-up (T2)
Pain severity change
The BPI was used to evaluate the individual's pain experience within the last 24 hours by four items, resulting in a total pain severity score. Minimum score 0, maximum score 10. The higher te score, the higher the pain severity.A change score between baseline (T0) and one year follow-up (T2) will be calculated.
Measured: Change from baseline (T0) to one year follow-up (T2)
Fear Avoidance and beliefs change
The fear avoidance and beliefs questionnaire (FABQ) will be used to assess fear avoidance behaviors. The first five items question physical activity, the other 11 activities work. A minimum score is 0, maximum 24. Higher scores indicate fear avoidance behaviors. A change score between baseline (T0) and one year follow-up (T2) will be calculated.
Measured: Change from baseline (T0) to one year follow-up (T2)
Anxiety and Depression change
The Hospital Anxiety and Depression Scale (HADS) was used to establish symptoms of anxiety and depression. This 14-item questionnaire consists of two subscales each including 7 items, the first to identify anxiety and the second depression. Individual items were scored from 0 to 3, resulting in a total range score of 0-21 for each subscale. A score of ≥8/21 was determined as a cut-off, indicating anxiety and depression.A change score between baseline (T0) and one year follow-up (T2) will be calculated.
Measured: Change from baseline (T0) to one year follow-up (T2)
Illness Perceptions change
The illness perceptions questionnaire (B-IPQ) includes nine items ranging from 0 (minimum) to 10 (maximum) and questions the perceptions related to the patients disease. No total score exists, as each item is scored individually. Higher scores indicate more negative or unhelpful illness perceptions. A change score between baseline (T0) and one year follow-up (T2) will be calculated.
Measured: Change from baseline (T0) to one year follow-up (T2)
Pain Catastrophizing change
The Pain Catastrophizing Scale (PCS) asked participants to reflect on previous painful experiences and to rate their degree of catastrophic thinking in the content domains of rumination, magnification and helplessness. A score of 0 (not at all) to 4 (all the time) was indicated for each of the 13 items, resulting in a total score range of 0-52. Higher scores were associated with higher levels of pain catastrophizing. A change score between baseline (T0) and one year follow-up (T2) will be calculated.
Measured: Change from baseline (T0) to one year follow-up (T2)
Pain localisation change
The body chart of the Brief Pain Inventory was used to investigate painful body sites. A change score between baseline (T0) and one year follow-up (T2) will be calculated.
Measured: Change from baseline (T0) to one year follow-up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start13 Feb 2020
- Primary completion28 Feb 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain, University Hospital, Antwerp
- Responsible party
- Principal investigator, Prof. dr. Mira Meeús, Universiteit Antwerpen
- Investigators
- Nathalie Roussel, Principal investigator, Universiteit AntwerpenCedric Hermans, Principal investigator, Cliniques universitaires Saint-Luc / UCLouvainCatherine Lambert, Principal investigator, Cliniques universitaires Saint-Luc / UCLouvainSébastien Lobet, Principal investigator, Cliniques universitaires Saint-Luc / UCLouvainPhilip Maes, Principal investigator, University Hospital, AntwerpAnthe Foubert, Principal investigator, University of Antwerp - UCLouvainValérie-Anne Chantrain, Principal investigator, University of Antwerp - UCLouvainMira Meeus, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606640
- Sponsor's protocol ID
- PAINSTUDY_2019
- Other IDs
- 2019/28OCT/469, B300201942304, 19/43/483, EDGE000540
- Status last verified
- May 2024
- First submitted
- 28 Oct 2022
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gaining Insight Into the Complexity of Pain in Patients With Haemophilia
- ClinicalTrials.gov ID
- NCT05606640
- Acronym / sponsor ID
- PAINSTUDY_2019
- Conditions
- Hemophilia A, Hemophilia B
- Keywords
- Haemophilia, arthropathy, Pain, Biopsychosocial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain, University Hospital, Antwerp
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Haemophilia | – | Diagnostic Test: Biopsychological pain assessmentAdult males with severe or moderate haemophilia A or B |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsychological pain assessmentAlso: 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 jointsAt 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. | Diagnostic test | Haemophilia |
Primary outcome
Pain localisation
Time frame: At baseline (T0)
The body chart of the Brief Pain Inventory (BPI) was used to investigate painful body sites.
Pain localisation
Time frame: At one year follow-up (T2)
The body chart of the Brief Pain Inventory (BPI) was used to investigate painful body sites.
Pain severity
Time frame: At baseline (T0)
The BPI was used to evaluate the individual's pain experience within the last 24 hours by four items, resulting in a total pain severity score. Minimum score 0, maximum score 10. The higher te score, the higher the pain severity.
Pain severity
Time frame: At one year follow-up (T2)
The BPI was used to evaluate the individual's pain experience within the last 24 hours by four items, resulting in a total pain severity score. Minimum score 0, maximum score 10. The higher te score, the higher the pain severity.
Pain interference
Time frame: At baseline (T0)
The BPI was used to evaluate how much pain interferes with patient's daily activities. This was assessed by seven items, resulting in a total pain interference score. Minimum score 0, maximum score 10. The higher the score, the more pain interference.
Pain interference
Time frame: At one year follow-up (T2)
The BPI was used to evaluate how much pain interferes with patient's daily activities. This was assessed by seven items, resulting in a total pain interference score. Minimum score 0, maximum score 10. The higher the score, the more pain interference.
Signs of neuropathic pain
Time frame: At baseline (T0)
The Douleur Neuropathique en 4 questions (DN4) was applied as a screening tool for the presence of a neuropathic pain component. Minimum score 0, maximum score 10, a score of ≥4/10 was used as a cut-off.
Signs of central sensitization
Time frame: At baseline (T0)
The Central Sensitisation Inventory (CSI) part A was used to identify signs of central sensitization (CS) i.e. increased sensitivity of nociceptive neurons in the central nervous system.The presence of 25 pain-related psychological, cognitive and functional signs are scored from 0 (never) to 4 (always). A total score exceeding ≥40/100 indicated central sensitization.
Pain Catastrophizing
Time frame: At baseline (T0)
The Pain Catastrophizing Scale (PCS) asked participants to reflect on previous painful experiences and to rate their degree of catastrophic thinking in the content domains of rumination, magnification and helplessness. A score of 0 (not at all) to 4 (all the time) was indicated for each of the 13 items, resulting in a total score range of 0-52. Higher scores were associated with higher levels of pain catastrophizing.
Anxiety and Depression
Time frame: At baseline (T0)
The Hospital Anxiety and Depression Scale (HADS) was used to establish symptoms of anxiety and depression. This 14-item questionnaire consists of two subscales each including 7 items, the first to identify anxiety and the second depression. Individual items were scored from 0 to 3, resulting in a total range score of 0-21 for each subscale. A score of ≥8/21 was determined as a cut-off, indicating anxiety and depression.
Fear Avoidance and Beliefs
Time frame: At baseline (T0)
The fear avoidance and beliefs questionnaire (FABQ) will be used to assess fear avoidance behaviors. The first five items question physical activity, the other 11 activities work. A minimum score is 0, maximum 24. Higher scores indicate fear avoidance behaviors.
Life quality
Time frame: At baseline (T0)
The EQ-5D-5L was used to assess quality of life. From five items investigating the impact of their disease, a health utility score was calculated. Additionally, the questionnaire consists of a visual analogue scale (VAS) labelled from 0: "worst imaginable health state," to 100 "best imaginable health state" providing the EQ-VAS.
Life quality
Time frame: At one year follow-up (T2)
The EQ-5D-5L was used to assess quality of life. From five items investigating the impact of their disease, a health utility score was calculated. Additionally, the questionnaire consists of a visual analogue scale (VAS) labelled from 0: "worst imaginable health state," to 100 "best imaginable health state" providing the EQ-VAS.
Haemophilia Activity Limitations
Time frame: At baseline (T0)
The Haemophilia Activity List (HAL) was used to assess activity limitations and participation restrictions people with haemophilia suffer with. A sum score and component scores can be calculated, resulting in scores ranging from 0-100. Lower scores represent higher levels of participation restrictions.
Physical endurance ability
Time frame: At baseline (T0)
The 2 minutes walking test (2MWT) was used as a performance-based test to assess their functional activity. Subjects were asked to walk as far as possible for two minutes in a 30 meters flat corridor, resulting in the walking distance in meters.
Physical functioning
Time frame: At baseline (T0)
The Timed Up \& Go (TUG) consists of asking the patient to sit on a standard armchair; stand up and walk 3 meters; turn around at the line and walk back to the chair and sit down at a normal pace.
Joint structure US
Time frame: At baseline (T0)
Ultrasound (US) examinations will be performed with a linear probe (3-13 MHz) Esaote, type MyLab Gamma, Genova, Italy).The Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) scanning procedure and scoring method will be performed by one of our investigators. A score of 0/8 (normal bone 0/2, normal cartilage 0/4, absent hypertrophic synovium 0/2) is considered normal. A score above 1/8 is considered as abnormal.
Joint structure MRI
Time frame: At baseline (T0)
Magnetic Reasoning Imaging (MRI) of the ankles will be performed with a 3T-magnet (GE Signa Premier, GE Healthcare, Milwaukee, USA).Joint images will be classified with the international Prophylaxis Study Group (IPSG) scale. Joints will be classified as abnormal if talocrural joints or subtalar joints were positive at IPSG-score. Joints will be considered healthy if the total score was of 1/17.
Illness perceptions
Time frame: At baseline (T0)
The illness perceptions questionnaire (B-IPQ) includes nine items ranging from 0 (minimum) to 10 (maximum) and questions the perceptions related to the patients disease. No total score exists, as each item is scored individually. Higher scores indicate more negative or unhelpful illness perceptions. A change score between baseline (T0) and one year follow-up (T2) will be calculated.
Illness perceptions
Time frame: At one year follow-up (T2)
The illness perceptions questionnaire (B-IPQ) includes nine items ranging from 0 (minimum) to 10 (maximum) and questions the perceptions related to the patients disease. No total score exists, as each item is scored individually. Higher scores indicate more negative or unhelpful illness perceptions. A change score between baseline (T0) and one year follow-up (T2) will be calculated.
Physical activity
Time frame: At baseline (T0)
The International Physical Activity Scale (IPAQ) questions the hours of physical activity over the last week (Higher scores are higher levels of physical activity). Based on the patient's answers a MET-minute score is calculated (MET-minutes x weight in kilograms/60kilograms)
Physical activity
Time frame: At one month follow-up (T1)
The International Physical Activity Scale (IPAQ) questions the hours of physical activity over the last week. Based on the patient's answers a MET-minute score is calculated (MET-minutes x weight in kilograms/60kilograms)
Joint function
Time frame: At baseline (T0)
Joint function of the ankles, knees and ankles was assessed with the HJHS 2.1. Minimum score is 0, maximum, 20. The higher the score the more functional limitations. HJHS scores are considered positive when scores reach 1/20.
Warm and cold detection threshold
Time frame: At baseline (T0)
Thermal hyper or hypo esthesia were assessed with a thermode attached at the dominant wrist by use of a validated Quantitative Sensory testing protocol with the Medoc TSA-2 device.
Warm and cold pain thresholds
Time frame: At baseline (T0)
Thermal hyper or hypo algesia were assessed with a thermode attached at the dominant wrist by use of a validated Quantitative Sensory testing protocol with the Medoc TSA-2 device.
Mechanical pain thresholds
Time frame: At baseline (T0)
Mechanical local and widespread hyperalgesia indicated by lower pressure pain thresholds were assessed with a digital algometer at the knee joints, ankle joints and forehead. This by use of a validated quantitative sensory testing protocol.
Temporal summation of pain
Time frame: At baseline (T0)
Temporal summation (or bottom-up sensitization) of pain was assessed by use of a 60g Von Frey monofilament at the medial knee and dorsal side of the wrist of the dominant side.
Conditioned Pain Modulation
Time frame: At baseline (T0)
Dysfunctional endogenous pain inhibition (as form of central pain processing) was assessed by a validated protocol applying the Medoc TSA-2 device with thermodes attached at both wrists.
7 secondary outcomes
Pain interference change
Time frame: Change from baseline (T0) to one year follow-up (T2)
Pain severity change
Time frame: Change from baseline (T0) to one year follow-up (T2)
Fear Avoidance and beliefs change
Time frame: Change from baseline (T0) to one year follow-up (T2)
Anxiety and Depression change
Time frame: Change from baseline (T0) to one year follow-up (T2)
Illness Perceptions change
Time frame: Change from baseline (T0) to one year follow-up (T2)
Pain Catastrophizing change
Time frame: Change from baseline (T0) to one year follow-up (T2)
Pain localisation change
Time frame: Change from baseline (T0) to one year follow-up (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Hemophilia A
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Roussel principal investigator
Universiteit Antwerpen
Cedric Hermans principal investigator
Cliniques universitaires Saint-Luc / UCLouvain
Catherine Lambert principal investigator
Cliniques universitaires Saint-Luc / UCLouvain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A and Hemophilia B, run by Universiteit Antwerpen at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain localisation (time frame: At baseline (T0)). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.