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HemophiliaNCT07516730

Central Pain Mechanisms and Clinical and Psychological Factors Associated With Pain Interference in Daily Life in Adults With Hemophilia and Hemophilic Arthropathy

An observational study of Hemophilia, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Introduction. Chronic pain is a frequent complication in adults with hemophilia and hemophilic arthropathy that affects functionality and quality of life. In addition to joint damage, central pain mechanisms and psychological factors may contribute to its functional impact, although evidence in this population is… Read more about this study

Who is it for?
Ages 35 years and older, men only
Conditions the study is for
Hemophilia
How many people
141 participants
Where
1 siteSpain
Study dates
22 Apr 2026to 11 Jul 2026
How long will I take part?
1 Day
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 35 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with hemophilia

Who may be able to join

  • Diagnosis of hemophilia A or B
  • Age equal to or greater than 35 years
  • Clinical diagnosis of hemophilic arthropathy in at least one lower limb joint
  • Clinically relevant joint involvement, defined as a total score on the Hemophilia Joint Health Score (HJHS) greater than 4 points
  • Stable prophylactic treatment with FVIII/FIX concentrates or monoclonal antibodies
  • Provision of written informed consent

Who cannot join

  • Presence of neurological or cognitive impairments that prevent understanding of the questionnaires or performance of the study tests
  • Episode of hemarthrosis in the lower limbs within the 3 months prior to assessment
  • Use of analgesics, nonsteroidal anti-inflammatory drugs, opioids, or other medications with potential effects on pain perception or modulation within the 72 hours prior to assessment
  • Receiving, at the time of the study, physiotherapy, infiltrative, or orthotic interventions aimed at pain or function of joints affected by hemophilic arthropathy

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Universidad de Oviedo

    Oviedo, Principality of Asturias, 33006

Other trials in Spain

About this study

Official title: Central Pain Mechanisms and Clinical and Psychological Factors Associated With Pain Interference in Daily Life in Adults With Hemophilia and Hemophilic Arthropathy: A Cross-Sectional Observational Study

Introduction. Chronic pain is a frequent complication in adults with hemophilia and hemophilic arthropathy that affects functionality and quality of life. In addition to joint damage, central pain mechanisms and psychological factors may contribute to its functional impact, although evidence in this population is limited.

Objective. To analyze the association between central pain mechanisms, pain intensity, and pain-related anxiety and pain interference in daily life in adults with hemophilia and hemophilic arthropathy, adjusting for relevant clinical variables.

Read more

Methods. An analytical observational study with a cross-sectional design will be conducted in 138 adults with hemophilia and hemophilic arthropathy. The dependent variable will be pain interference in daily life (Brief Pain Inventory), the main predictor variables will be central sensitization (Central Sensitization Inventory), conditioned pain modulation (Conditioned Pain Modulation Index), global pain intensity (severity subscale of the Brief Pain Inventory), and pain-related anxiety (Pain Anxiety Symptoms Scale-20). As secondary predictor variables, sleep quality (Pittsburgh Sleep Quality Index) and pain self-efficacy (Pain Self-Efficacy Questionnaire) will be included. As confounding variables, joint damage, age, type of treatment, and history of inhibitor will be considered. The association between variables will be analyzed using multiple linear regression models adjusted for relevant clinical covariates.

Expected results. It is expected to identify factors associated with pain interference in adults with hemophilia and hemophilic arthropathy, improving the understanding of its functional impact.

Conditions
Hemophilia
Keywords
Hemophilia, Chronic pain, Pain measurement, Pain perception, Anxiety, Self-efficacy
Medical subject headings
Hemophilia A, Chronic Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07516730
Study groupRoleWhat they receive
Observational groupadults with hemophilia and hemophilic arthropathy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of pain interference in daily life and global pain intensity at baseline.

    The Brief Pain Inventory (BPI-Interference) will be used to assess pain interference in daily life and global pain intensity. This instrument measures the extent to which pain interferes with basic and relevant activities such as general activity, walking, normal work, mood, sleep, social relations, and enjoyment of life. It does not assess pain mechanisms, but rather their perceived functional impact. It consists of 7 items scored from 0 to 10 (0: does not interfere; 10: completely interferes), and the total score is obtained by calculating the mean of the items.

    Measured: Baseline

Secondary outcomes (6)
  1. Assessment of central sensitisation at baseline.

    The Spanish version of the Central Sensitization Inventory will be used to assess the presence of central sensitisation in patients. This inventory includes a first part with 25 items that assess symptoms associated with central sensitisation. Each item is evaluated using a 5-point Likert scale with a numerical hierarchy: Never (0), Rarely (1), Sometimes (2), Often (3), and Always (4). The second part assesses whether the patient has any diagnosis among a list of 10 disorders, including the year of diagnosis. The score of the first part ranges from 0 to 100 points, where higher scores indicate greater clinical severity.

    Measured: Baseline

  2. Assessment of conditioned pain modulation at baseline.

    The Conditioned Pain Modulation Index (CPMI) will be used to assess endogenous pain inhibitory function. Pressure pain threshold (PPT) will be measured at the dorsal aspect of the distal phalanx of the thumb before and during a conditioned stimulus induced by an ischemic test in the contralateral upper limb (sphygmomanometer inflated to 240 mmHg). Patients will report pain intensity on a numerical rating scale (0-10) until reaching 7/10, supported by wrist extension exercises if needed. PPT will be reassessed during the conditioned stimulus. The cuff will remain inflated for up to 6 minutes.

    Measured: Baseline

  3. Assessment of pain-related anxiety at baseline.

    The Pain Anxiety Symptoms Scale-20 (PASS-20) will be used to assess levels of pain-related anxiety. This scale includes 20 items and measures anxiety and fear responses associated with the experience of chronic or recurrent pain. Each item is scored on a scale from 0 to 5, where 0 indicates "never" and 5 indicates "always". It evaluates different dimensions of pain-related anxiety, including cognitive, physiological, and behavioural responses associated with pain experience.

    Measured: Baseline

  4. Assessment of sleep quality at baseline.

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. The original version consists of 19 items. The first four items have an open-ended response format and assess sleep duration. The remaining items are related to sleep disturbances and daytime dysfunction. Using a 4-point Likert scale, the frequency of each situation is indicated (0: not during the last month; 1: less than once per week; 2: once or twice per week; 3: three or more times per week) and overall sleep quality is rated (0: very good; 1: fairly good; 2: fairly bad; 3: very bad). Scores are distributed across different components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component ranges from 0 to 3, with a global score ranging from 0 to 21. Higher scores indicate greater disturbance in the evaluated sleep components. A global score greater than

    Measured: Baseline

  5. Assessment of pain self-efficacy at baseline.

    The Pain Self-Efficacy Questionnaire (PSEQ) will be used as a self-report tool to assess the degree of perceived self-efficacy of patients in relation to pain, that is, the confidence of an individual to perform functional and daily life activities in the presence of chronic pain. It is used in individuals with chronic musculoskeletal pain. It consists of 10 items related to activities such as household tasks, work, social activities, and coping with pain, regardless of perceived pain intensity. Each item is measured on a 7-point Likert scale (0: not at all confident; 6: completely confident), with a maximum score of 60 points. Higher scores indicate greater pain self-efficacy.

    Measured: Baseline

  6. Assessment of joint damage at baseline.

    The Hemophilia Joint Health Score (HJHS) will be used to assess joint damage. It is a scale designed to identify joint degeneration in elbows, knees, and ankles in children, adolescents, and adults with hemophilia. It consists of 8 items: swelling and its duration, pain, muscle atrophy and strength, crepitus, and loss of flexion and extension. Scores range from 0 to 20 points (maximum joint damage) per joint. For total joint damage assessment, a gait evaluation is added (range 0-4 points), with a maximum total score of 124 points.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2026
  2. Study start22 Apr 2026
  3. Primary completion30 Jun 2026
  4. Study completion11 Jul 2026

Resources

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
141 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07516730
Sponsor's protocol ID
HE-DOLIFE
Status last verified
Apr 2026
First submitted
1 Apr 2026
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Hemophilia, 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 4 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 3 Aug 2026. 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?

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?

Assessment of pain interference in daily life and global pain intensity at baseline. (time frame: Baseline). 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 3 Aug 2026.

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