Chronic Pain and Hemophilia (HEMODOL)

May 28, 2026 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU de Bordeaux
      • Caen, France
        • Centre Hospitalier Universitaire de Caen Normandie
      • Chambéry, France
        • CH métropole Savoie
      • Clermont-Ferrand, France, 63000
        • CHU de Clermont-Ferrand
      • Grenoble, France
        • CHU de GRENOBLE
      • Lille, France
        • CHU de Lille
      • Lyon, France
        • Hospices Civils de Lyon
      • Nantes, France
        • Centre Hospitalier Universitaire de Nantes
      • Saint-Etienne, France
        • CHU de Saint-Etienne
      • Toulouse, France
        • CHU de Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with hemophilia

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with hemophilia
all adult patients follow-upin Hospital for hemophilia
Other: questionnaires
Electronic case report form integrating questionnaires on chronic pain related to haemophilia, associated-comorbidities, sociodemographic characteristics and analgesic treatments used.
Other Names:
  • RedCap web platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of chronic pain in daily life
Time Frame: through study completion, an average of 1 year
Specific questions + Western Ontario and McMaster University Osteoarthritis (WOMAC)
through study completion, an average of 1 year
Analgesic consumption
Time Frame: through study completion, an average of 1 year
Type and quantity of analgesic used for treating chronic pain
through study completion, an average of 1 year
Anxiodepressive disorders
Time Frame: through study completion, an average of 1 year
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.
through study completion, an average of 1 year
Sleep disorders
Time Frame: through study completion, an average of 1 year
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.
through study completion, an average of 1 year
Perceived injustice of chronic pain
Time Frame: through study completion, an average of 1 year
Injustice Experience Questionnaire (IEQ)
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Aurélien LEBRETON, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2022

Primary Completion (Actual)

December 18, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 10, 2022

First Submitted That Met QC Criteria

January 10, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNI 2021 LEBRETON 2
  • 2021-A01217-34 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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