Chronic PainHEMODOLNCT05202951
Chronic Pain and Hemophilia
An observational study of Chronic Pain and Hemophilia, run by University Hospital, Clermont-Ferrand at 10 sites in France.
Trial summary
Hemophilia (A and B) are X-linked hereditary bleeding disorders whose severity depends on the level of coagulation factor (FVIII or FIX respectively). Bleeding is mainly from joints (hemarthrosis) and muscles (hematoma). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Hemophilia
- What is being tested?
- questionnaires
- How many people
- 350 participants
- Where
- 10 sitesFrance
- Study dates
- 28 Feb 2022to Sep 2026
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hemophilia
Who may be able to join
- Patient with haemophilia of any severity,
- Carrier female with low levels haemophilia (< 40%),
- ≥ 18 years of age and capable of giving informed consent to participate in research.
Who cannot join
- Patient's refusal to participate in the survey,
- Patient does not understand enough French (written and spoken) to complete the survey,
- Patient unable to complete the survey for logistical reasons (lack of internet access),
- Patient under protective measures (guardianship),
- Patients with known addictive comorbidities and/or cognitive disorders.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU de Bordeaux
Bordeaux
Centre Hospitalier Universitaire de Caen Normandie
Caen
CH Métropole Savoie
Chambéry
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
CHU de Grenoble
Grenoble
CHU de LILLE
Lille
Hospices Civils de Lyon
Lyon
Centre Hospitalier Universitaire de Nantes
Nantes
CHU de Saint-Etienne
Saint-Etienne
CHU de TOULOUSE
Toulouse
About this study
Official title: Status of Chronic Pain in Patients With Hemophilia.
Hemophilia (A and B) are X-linked hereditary bleeding disorders whose severity depends on the level of coagulation factor (FVIII or FIX respectively). Bleeding is mainly from joints (hemarthrosis) and muscles (hematoma). Nowadays, treatment is based on preventive or curative intravenous infusion of coagulation factor concentrates. Despite these treatments, there is joint deterioration that can be responsible for hemophilic arthropathy and chronic pain. This pain may be related to excess nociception during acute bleeding, but it may also be neuropathic. There are only a few studies that have looked at pain in hemophilia, but it is accepted that the vast majority of patients (especially those with severe forms) suffer from chronic pain. Because patients have become accustomed to this pain and physicians are still not very aware of how to assess it, this pain is not treated effectively.
In order to better manage pain in hemophilia, it is therefore necessary to characterize their pain and to know the nociceptive or neuropathic component. The aim of our study is therefore to study the prevalence, the nociceptive or neuropathic profile, the chronic aspect of pain and the main locations of pain in hemophilia. In addition to raising the awareness of physicians in the centers about pain management using specific questionnaires, this survey will help to better define chronic pain in hemophilia of all severities.
Read the detailed description
This first French assessment of chronic pain in patients with haemophilia will permit to improve and generate new data about chronic pain related to haemophilia, associated-comorbidities, sociodemographic characteristics and analgesic treatments used.
These data will be retrieved using several questionnaires in the RedCap web plateform (eCRF).
The study will include 6 investigator centres and a minimum of 350 patients during 12 months.
- Conditions
- Chronic Pain, Hemophilia
- Being tested
- questionnaires
- Keywords
- Chronic Pain, Hemophilia
- Medical subject headings
- Chronic Pain, Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
Also called RedCap web platform
Electronic case report form integrating questionnaires on chronic pain related to haemophilia, associated-comorbidities, sociodemographic characteristics and analgesic treatments used.
| Study group | Role | What they receive |
|---|---|---|
| Patients with hemophilia | all adult patients follow-upin Hospital for hemophilia Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of chronic pain disorders
Questionnaire "Brief Pain Inventory" (BPI) + History of chronic pain (≥ 3 months, Yes or No)
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Impact of chronic pain in daily life
Specific questions + Western Ontario and McMaster University Osteoarthritis (WOMAC)
Measured: through study completion, an average of 1 year
Analgesic consumption
Type and quantity of analgesic used for treating chronic pain
Measured: through study completion, an average of 1 year
Anxiodepressive disorders
Hospital Anxiety and Depression scale (HADS): this questionnaire makes it possible to detect anxiety and depressive disorders. It has 14 items sided from 0 to 3. Seven questions relate to anxiety and the 7 to the depressive dimension, thus obtaining two scores of up to 21.
Measured: through study completion, an average of 1 year
Sleep disorders
MOS-Sleep scale (MOS-SS) questionnaire: this questionnaire deals with daytime sleepiness. It also looks at a person's ability to stay and fall asleep, how often they sleep and for how long, whether the sleep they get is adequate for their lifestyle, and any existing breathing factors that can affect sleep like sleep apnea.
Measured: through study completion, an average of 1 year
Perceived injustice of chronic pain
Injustice Experience Questionnaire (IEQ)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start28 Feb 2022
- Primary completion18 Dec 2025
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélien LEBRETON, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202951
- Sponsor's protocol ID
- RNI 2021 LEBRETON 2
- Other IDs
- 2021-A01217-34
- Acronym
- HEMODOL
- Status last verified
- May 2026
- First submitted
- 10 Jan 2022
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Status of Chronic Pain in Patients With Hemophilia.
- ClinicalTrials.gov ID
- NCT05202951
- Acronym / sponsor ID
- HEMODOL / RNI 2021 LEBRETON 2
- Conditions
- Chronic Pain, Hemophilia
- Keywords
- Chronic Pain, Hemophilia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 24 Jan 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.
Hemophilia (A and B) are X-linked hereditary bleeding disorders whose severity depends on the level of coagulation factor (FVIII or FIX respectively). Bleeding is mainly from joints (hemarthrosis) and muscles (hematoma). Nowadays, treatment is based on preventive or curative intravenous infusion of coagulation factor concentrates. Despite these treatments, there is joint deterioration that can be responsible for hemophilic arthropathy and chronic pain. This pain may be related to excess nociception during acute bleeding, but it may also be neuropathic. There are only a few studies that have looked at pain in hemophilia, but it is accepted that the vast majority of patients (especially those with severe forms) suffer from chronic pain. Because patients have become accustomed to this pain and physicians are still not very aware of how to assess it, this pain is not treated effectively.
In order to better manage pain in hemophilia, it is therefore necessary to characterize their pain and to know the nociceptive or neuropathic component. The aim of our study is therefore to study the prevalence, the nociceptive or neuropathic profile, the chronic aspect of pain and the main locations of pain in hemophilia. In addition to raising the awareness of physicians in the centers about pain management using specific questionnaires, this survey will help to better define chronic pain in hemophilia of all severities.
Detailed description
This first French assessment of chronic pain in patients with haemophilia will permit to improve and generate new data about chronic pain related to haemophilia, associated-comorbidities, sociodemographic characteristics and analgesic treatments used.
These data will be retrieved using several questionnaires in the RedCap web plateform (eCRF).
The study will include 6 investigator centres and a minimum of 350 patients during 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hemophilia | – | Other: questionnairesall adult patients follow-upin Hospital for hemophilia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hemophilia
Key inclusion criteria (3 listed)
- Patient with haemophilia of any severity,
- Carrier female with low levels haemophilia (< 40%),
- ≥ 18 years of age and capable of giving informed consent to participate in research.
Key exclusion criteria (5 listed)
- Patient's refusal to participate in the survey,
- Patient does not understand enough French (written and spoken) to complete the survey,
- Patient unable to complete the survey for logistical reasons (lack of internet access),
- Patient under protective measures (guardianship),
- Patients with known addictive comorbidities and/or cognitive disorders.
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 |
|---|---|---|
| questionnairesAlso: RedCap web platformElectronic case report form integrating questionnaires on chronic pain related to haemophilia, associated-comorbidities, sociodemographic characteristics and analgesic treatments used. | Other | Patients with hemophilia |
Primary outcome
Prevalence of chronic pain disorders
Time frame: through study completion, an average of 1 year
Questionnaire "Brief Pain Inventory" (BPI) + History of chronic pain (≥ 3 months, Yes or No)
5 secondary outcomes
Impact of chronic pain in daily life
Time frame: through study completion, an average of 1 year
Analgesic consumption
Time frame: through study completion, an average of 1 year
Anxiodepressive disorders
Time frame: through study completion, an average of 1 year
Sleep disorders
Time frame: through study completion, an average of 1 year
Perceived injustice of chronic pain
Time frame: through study completion, an average of 1 year
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 29 May 2026.
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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. This study is not recruiting at the moment.
Aurélien LEBRETON principal investigator
University Hospital, Clermont-Ferrand
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Hemophilia, run by University Hospital, Clermont-Ferrand at 10 sites in France.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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?
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?
Prevalence of chronic pain disorders (time frame: through study completion, an average of 1 year). 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 29 May 2026.