Hemophilia A Without InhibitorNCT07096349
Multidimensional Assessment of Chronic Pain in Severe Haemophilia A
An observational study of Hemophilia A Without Inhibitor, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Introduction: Haemophilia is a congenital coagulopathy characterised by haemarthrosis, mainly in the knees, ankles and elbows. Prophylactic treatment is the most effective therapeutic option for preventing or minimising these bleeds. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hemophilia A Without Inhibitor
- How many people
- 109 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jul 2025to 26 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with haemophilia who meet the selection criteria will be informed of the characteristics of the study and the objectives to be achieved. Subjects included in the study will be required to complete a workbook containing a series of questionnaires designed to assess chronic residual pain and pain catastrophising, perceived self-efficacy in relation to the disease and treatment, and body image and perception of visible disability in patients with haemophilia.
Who may be able to join
- Patients over 18 years of age.
- With a medical diagnosis of severe haemophilia A (FVIII < 1%).
- No inhibitors to FVIII concentrates at the time of the study.
- At least 3 months of treatment with bispecific monoclonal antibodies.
- Medical diagnosis of haemophilic arthropathy in at least two lower limb joints and ≥5 points on the Haemophilia Joint Health Score.
- Ability to understand and respond to self-administered questionnaires.
Who cannot join
- Patients diagnosed with severe musculoskeletal or neurological comorbidities causing chronic pain.
- Individuals with neurological or cognitive impairments that prevent them from understanding the questionnaires.
- Patients who have participated in an interventional clinical study in the 6 months prior to the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universidad de Oviedo
Oviedo, Principality of Asturias, 33006
Rubén Cuesta-Barriuso, 607547274, cuestaruben@uniovi.es
About this study
Official title: Multidimensional Assessment of Chronic Pain in Severe Haemophilia A Treated With Monoclonal Antibodies: an Observational Study; an Ambispective Cohort Study
Introduction: Haemophilia is a congenital coagulopathy characterised by haemarthrosis, mainly in the knees, ankles and elbows. Prophylactic treatment is the most effective therapeutic option for preventing or minimising these bleeds. Bispecific monoclonal antibodies have been shown to be effective in reducing bleeding in patients with haemophilia.
Objectives: To investigate the associations between chronic residual pain and pain catastrophising, perceived self-efficacy regarding the disease and treatment, and body image and perception of visible disability.
Read more
Methods. Multicentre cross-sectional cohort studies. 109 patients with severe haemophilia A from different regions of Spain will be included in the study. The primary variable will be chronic residual pain and its functional interference (Brief Pain Inventory-Short Form). Secondary variables will be pain catastrophising (Pain Catastrophising Scale), perceived self-efficacy regarding the disease and treatment (Pain Self-Efficacy Questionnaire), and body image and perception of visible disability (Body Image Scale). Potential confounding variables will include sociodemographic variables (age and educational level), clinical variables (time on monoclonal antibody treatment and number of previous bleeds in the last 12 months) and anthropometric variables (body mass index).
Expected results: It is expected that residual chronic pain will persist in patients with severe haemophilia A treated with monoclonal antibodies and that it will be associated with greater catastrophising, lower self-efficacy and poorer body image, modulating the experience of pain beyond bleeding control.
- Conditions
- Hemophilia A Without Inhibitor
- Keywords
- Hemophilia, Bispecific monoclonal antibodies, Chronic pain, Catastrophising, Self-efficacy, Body image
- Medical subject headings
- Hemophilia A, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational group | Patients with severe haemophilia A from different regions of Spain will be included in the study. Patients who meet the selection criteria will be informed of the characteristics and objectives of the study. They will be provided with an information and informed consent document. After confirming that they do not meet any of the exclusion criteria, the primary and secondary dependent variables and confounding factors will be assessed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of residual chronic pain and its functional interference at the time of the study.
Chronic residual pain and its functional interference will be assessed using the Spanish version of the Brief Pain Inventory-Short Form (BPI-SF). This multidimensional self-administered questionnaire explores pain intensity using four items: maximum, minimum, average and current pain, on a scale of 0-10. The degree of interference of pain in daily life is assessed using seven items: mood, activity, work, relationships, sleep, enjoyment of life, and walking, on a scale of 0-10. An average score is calculated for each dimension (intensity and interference). This instrument has shown excellent reliability and validity
Measured: Screening visit
Secondary outcomes (3)
Assessment of catastrophising at the time of the study.
Catastrophising will be assessed using the Spanish version of the Pain Catastrophising Scale (PCS). This self-reported questionnaire consists of 13 items measuring three cognitive dimensions related to pain: rumination, magnification and hopelessness. Each item is scored on a Likert scale from 0 ('never') to 4 ('always'), and the total score ranges from 0 to 52. Higher scores indicate higher levels of catastrophising. This tool has shown excellent internal consistency and test-retest reliability. This scale can predict pain intensity and emotional response in clinical and experimental contexts.
Measured: Screening visit
Assessment of perceived self-efficacy for managing chronic pain at the time of the study.
Perceived self-efficacy for managing chronic pain will be assessed using the Pain Self-Efficacy Questionnaire (PSEQ). This instrument measures the degree to which a person with chronic pain trusts their ability to perform daily activities despite pain. It consists of 10 items, each scored on a 7-point Likert scale ranging from 0 ('not at all confident') to 6 ('completely confident'). The total score ranges from 0 to 60, with higher values indicating greater self-efficacy. The Spanish version of the PSEQ has shown excellent internal consistency and test-retest reliability.
Measured: Screening visit
Assessment of body image perception at the time of the study.
Body image perception will be assessed using the Spanish version of the Body Image Scale (BIS). This instrument, designed for patients after cancer treatment, consists of 10 self-administered items that assess body image distress resulting from this treatment. It uses a 4-point Likert scale (0 = 'not at all' to 3 = 'very much'). The total score ranges from 0 to 30, with higher values indicating greater impairment. The adaptation to Spanish showed excellent internal consistency.
Measured: Screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start30 Jul 2025 (estimated)
- Primary completion3 Oct 2025 (estimated)
- Study completion26 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia A Without InhibitorStudies 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
- Cross-sectional
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Rubén Cuesta-Barriuso, Investigación en Hemofilia y Fisioterapia
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad de Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096349
- Sponsor's protocol ID
- He-MoN
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Assessment of Chronic Pain in Severe Haemophilia A Treated With Monoclonal Antibodies: an Observational Study; an Ambispective Cohort Study
- ClinicalTrials.gov ID
- NCT07096349
- Acronym / sponsor ID
- He-MoN
- Conditions
- Hemophilia A Without Inhibitor
- Keywords
- Hemophilia, Bispecific monoclonal antibodies, Chronic pain, Catastrophising, Self-efficacy, Body image
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 3 Oct 2025 (estimated)
- Study completion
- 26 Oct 2025 (estimated)
- First posted
- 31 Jul 2025 (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.
Introduction: Haemophilia is a congenital coagulopathy characterised by haemarthrosis, mainly in the knees, ankles and elbows. Prophylactic treatment is the most effective therapeutic option for preventing or minimising these bleeds. Bispecific monoclonal antibodies have been shown to be effective in reducing bleeding in patients with haemophilia.
Objectives: To investigate the associations between chronic residual pain and pain catastrophising, perceived self-efficacy regarding the disease and treatment, and body image and perception of visible disability.
Methods. Multicentre cross-sectional cohort studies. 109 patients with severe haemophilia A from different regions of Spain will be included in the study. The primary variable will be chronic residual pain and its functional interference (Brief Pain Inventory-Short Form). Secondary variables will be pain catastrophising (Pain Catastrophising Scale), perceived self-efficacy regarding the disease and treatment (Pain Self-Efficacy Questionnaire), and body image and perception of visible disability (Body Image Scale). Potential confounding variables will include sociodemographic variables (age and educational level), clinical variables (time on monoclonal antibody treatment and number of previous bleeds in the last 12 months) and anthropometric variables (body mass index).
Expected results: It is expected that residual chronic pain will persist in patients with severe haemophilia A treated with monoclonal antibodies and that it will be associated with greater catastrophising, lower self-efficacy and poorer body image, modulating the experience of pain beyond bleeding control.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | –Patients with severe haemophilia A from different regions of Spain will be included in the study. Patients who meet the selection criteria will be informed of the characteristics and objectives of the study. They will be provided with an information and informed consent document. After confirming that they do not meet any of the exclusion criteria, the primary and secondary dependent variables and confounding factors will be assessed |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with haemophilia who meet the selection criteria will be informed of the characteristics of the study and the objectives to be achieved. Subjects included in the study will be required to complete a workbook containing a series of questionnaires designed to assess chronic residual pain and pain catastrophising, perceived self-efficacy in relation to the disease and treatment, and body image and perception of visible disability in patients with haemophilia.
Key inclusion criteria (6 listed)
- Patients over 18 years of age.
- With a medical diagnosis of severe haemophilia A (FVIII < 1%).
- No inhibitors to FVIII concentrates at the time of the study.
- At least 3 months of treatment with bispecific monoclonal antibodies.
- Medical diagnosis of haemophilic arthropathy in at least two lower limb joints and ≥5 points on the Haemophilia Joint Health Score.
Key exclusion criteria (3 listed)
- Patients diagnosed with severe musculoskeletal or neurological comorbidities causing chronic pain.
- Individuals with neurological or cognitive impairments that prevent them from understanding the questionnaires.
- Patients who have participated in an interventional clinical study in the 6 months prior to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of residual chronic pain and its functional interference at the time of the study.
Time frame: Screening visit
Chronic residual pain and its functional interference will be assessed using the Spanish version of the Brief Pain Inventory-Short Form (BPI-SF). This multidimensional self-administered questionnaire explores pain intensity using four items: maximum, minimum, average and current pain, on a scale of 0-10. The degree of interference of pain in daily life is assessed using seven items: mood, activity, work, relationships, sleep, enjoyment of life, and walking, on a scale of 0-10. An average score is calculated for each dimension (intensity and interference). This instrument has shown excellent reliability and validity
3 secondary outcomes
Assessment of catastrophising at the time of the study.
Time frame: Screening visit
Assessment of perceived self-efficacy for managing chronic pain at the time of the study.
Time frame: Screening visit
Assessment of body image perception at the time of the study.
Time frame: Screening visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Rubén Cuesta-Barriuso, PhD principal investigator
Universidad de Oviedo
1 site 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 Without Inhibitor, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rubén Cuesta-Barriuso, PhD (0034 985103386, cuestaruben@uniovi.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of residual chronic pain and its functional interference at the time of the study. (time frame: Screening visit). 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 1 Aug 2025.