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NCT Number: NCT05202951

Chronic Pain and 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

questionnaires

Other

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. Analgesic consumption

    Time frame: through study completion, an average of 1 year

    Type and quantity of analgesic used for treating chronic pain

  3. 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.

  4. 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.

  5. Perceived injustice of chronic pain

    Time frame: through study completion, an average of 1 year

    Injustice Experience Questionnaire (IEQ)

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Status of Chronic Pain in Patients With Hemophilia.

Acronym: HEMODOL

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jan 24, 2022
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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