HemophiliaNCT07110675
Central Sensitisation in Patients With Haemophilia and Degenerative Arthropathy
An observational study of Hemophilia, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Introduction: Hemophilic arthropathy is characterized by functional impairments, disabling physical sequelae, and chronic pain. Central pain sensitization describes increased neural excitability characterized by spontaneous or persistent pain, increased pain areas, allodynia, and hyperalgesia. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hemophilia
- How many people
- 146 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2025to 15 Dec 2025
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hemophilia and degenerative knee and ankle arthropathy
Who may be able to join
- Patients diagnosed with haemophilia A and B.
- Over 35 years of age.
- With a medical diagnosis of bilateral haemophilic ankle arthropathy.
- With a clinical assessment using the Hemophilia Joint Health Score greater than 4 points.
- On prophylactic treatment with FVIII/FIX coagulation concentrates or monoclonal antibodies.
- Sign the informed consent document.
Who cannot join
- Patients with neurological or cognitive impairments that prevent them from understanding the questionnaires and physical tests.
- Patients who have had ankle or knee haemarthrosis in the 6 months prior to the start of the study.
- Patients who have taken analgesic or anti-inflammatory drugs in the 10 days prior to the study.
- Patients who are undergoing an intervention (physiotherapy or orthopaedic) at the time of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Central Sensitisation in Patients With Haemophilia and Degenerative Arthropathy of the Lower Limbs. A Cross-sectional Cohort Study
Introduction: Hemophilic arthropathy is characterized by functional impairments, disabling physical sequelae, and chronic pain. Central pain sensitization describes increased neural excitability characterized by spontaneous or persistent pain, increased pain areas, allodynia, and hyperalgesia.
Objectives: To evaluate central pain sensitization in patients with hemophilia and degenerative knee and ankle arthropathy and to identify the best predictive model of central pain sensitization in these patients.
Read more
Methods: Multicenter cross-sectional cohort study. Eighty-six patients with hemophilic knee and ankle arthropathy will be recruited through the Spanish Hemophilia Federation. The primary outcome measure will be central pain sensitization (Central Sensitization Inventory), with age as the dependent variable. The secondary variables will be kinesiophobia (Tampa Scale for Kinesiophobia), catastrophizing (Pain Catastrophizing Scale), and pain anxiety (Pain Anxiety Symptoms Scale-20). The variables estimated as modifiers or confounders will be pain intensity (Visual Analogue Scale), joint status (Hemophilia Joint Health Score), severity and type of hemophilia, development of inhibitors, and sociodemographic variables.
Expected results: To identify the degree of central pain sensitization in patients with hemophilic arthropathy. To identify the best predictive model for central pain sensitization in these patients based on the study variables.
- Conditions
- Hemophilia
- Keywords
- Hemophilia, Joint pain, Central sensitization, Disability, Kinesiophobia, Catastrophizing, Anxiety, Depression
- Medical subject headings
- Hemophilia A, Arthralgia, Kinesiophobia, Anxiety Disorders, Depression
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 who meet all inclusion criteria will be informed verbally and in writing of the characteristics, objectives, and risks of the intervention. They will be provided with patient information and informed consent documents. After confirming that they do not meet any of the exclusion criteria, the dependent and confounding variables of the study will be evaluated. The evaluation will be carried out at the premises of the member associations of the Spanish Hemophilia Federation. All evaluations will be performed by the same physical therapist, following the same evaluation protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of central pain sensitivity at baseline.
The Spanish version of the Central Sensitisation Inventory will be used to assess the presence of central sensitisation in patients. The first part of this inventory consists of 25 items that assess possible healthy symptoms. Each item is assessed 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 been diagnosed with any of a list of 10 disorders, including the year of diagnosis. The reliability of this inventory is very high (ICC: 0.82-0.97). The assessment of the first part of this tool ranges from 0 to 100 points, where the higher the score, the greater the clinical severity of the patients.
Measured: Baseline
Secondary outcomes (4)
Assessment of fear of movement at baseline
Fear of movement will be assessed using the Spanish version of the Tampa Scale of Kinesiophobia (TSK-11SV). This scale consists of 11 items, each of which can be scored from 1 to 4. This scale shows high reliability (ICC = 0.87). The score range on the scale is 11 to 44 points, with higher scores indicating greater fear of movement.
Measured: Baseline
Assessment of catastrophising at baseline
The catastrophising of the patients in the study will be measured using the validated Spanish version of the Pain Catastrophising Scale. This scale consists of 13 items, each of which can be scored from 0 to 4. This scale has demonstrated high reliability (ICC = 0.84). The scale ranges from 0 to 52 points, with higher scores indicating greater catastrophising.
Measured: Baseline
Assessment of pain anxiety levels at baseline
The Pain Anxiety Symptoms Scale-20 (PASS-20) will be used to assess levels of anxiety related to pain. This scale has 20 items and measures anxiety and fear responses associated with the experience of chronic or recurrent pain. Each item is rated on a 5-point scale, from 0 (never) to 5 (always). It consists of four domains that measure cognitive anxiety responses, escape and avoidance, fearful thoughts, and physiological anxiety responses. This instrument has shown moderate reliability (CCI= 0.71).
Measured: Baseline
Assessment of pressure pain threshold
Pressure pain threshold (PPT) at the forearm distal to the painful point will be measured using a handheld algometer with a 1 cm² probe applied perpendicularly to the previously identified site, increasing pressure at a constant rate (≈30 kPa/s or 1 kg/cm²/s) until the participant indicates the transition from pressure to pain; three measurements will be obtained and their mean will be calculated. Unit of measurement: N.
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 posted7 Aug 2025
- Study start1 Aug 2025
- Primary completion28 Oct 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies 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
- 146 participants (actual)
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
- NCT07110675
- Sponsor's protocol ID
- He-Sens
- Status last verified
- Jul 2025
- First submitted
- 25 Jul 2025
- Last updated
- 20 Feb 2026
- 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 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Central Sensitisation in Patients With Haemophilia and Degenerative Arthropathy of the Lower Limbs. A Cross-sectional Cohort Study
- ClinicalTrials.gov ID
- NCT07110675
- Acronym / sponsor ID
- He-Sens
- Conditions
- Hemophilia
- Keywords
- Hemophilia, Joint pain, Central sensitization, Disability, Kinesiophobia, Catastrophizing, Anxiety, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 7 Aug 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: Hemophilic arthropathy is characterized by functional impairments, disabling physical sequelae, and chronic pain. Central pain sensitization describes increased neural excitability characterized by spontaneous or persistent pain, increased pain areas, allodynia, and hyperalgesia.
Objectives: To evaluate central pain sensitization in patients with hemophilia and degenerative knee and ankle arthropathy and to identify the best predictive model of central pain sensitization in these patients.
Methods: Multicenter cross-sectional cohort study. Eighty-six patients with hemophilic knee and ankle arthropathy will be recruited through the Spanish Hemophilia Federation. The primary outcome measure will be central pain sensitization (Central Sensitization Inventory), with age as the dependent variable. The secondary variables will be kinesiophobia (Tampa Scale for Kinesiophobia), catastrophizing (Pain Catastrophizing Scale), and pain anxiety (Pain Anxiety Symptoms Scale-20). The variables estimated as modifiers or confounders will be pain intensity (Visual Analogue Scale), joint status (Hemophilia Joint Health Score), severity and type of hemophilia, development of inhibitors, and sociodemographic variables.
Expected results: To identify the degree of central pain sensitization in patients with hemophilic arthropathy. To identify the best predictive model for central pain sensitization in these patients based on the study variables.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | –Patients who meet all inclusion criteria will be informed verbally and in writing of the characteristics, objectives, and risks of the intervention. They will be provided with patient information and informed consent documents. After confirming that they do not meet any of the exclusion criteria, the dependent and confounding variables of the study will be evaluated. The evaluation will be carried out at the premises of the member associations of the Spanish Hemophilia Federation. All evaluations will be performed by the same physical therapist, following the same evaluation protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hemophilia and degenerative knee and ankle arthropathy
Key inclusion criteria (6 listed)
- Patients diagnosed with haemophilia A and B.
- Over 35 years of age.
- With a medical diagnosis of bilateral haemophilic ankle arthropathy.
- With a clinical assessment using the Hemophilia Joint Health Score greater than 4 points.
- On prophylactic treatment with FVIII/FIX coagulation concentrates or monoclonal antibodies.
Key exclusion criteria (4 listed)
- Patients with neurological or cognitive impairments that prevent them from understanding the questionnaires and physical tests.
- Patients who have had ankle or knee haemarthrosis in the 6 months prior to the start of the study.
- Patients who have taken analgesic or anti-inflammatory drugs in the 10 days prior to the study.
- Patients who are undergoing an intervention (physiotherapy or orthopaedic) at the time of 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 central pain sensitivity at baseline.
Time frame: Baseline
The Spanish version of the Central Sensitisation Inventory will be used to assess the presence of central sensitisation in patients. The first part of this inventory consists of 25 items that assess possible healthy symptoms. Each item is assessed 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 been diagnosed with any of a list of 10 disorders, including the year of diagnosis. The reliability of this inventory is very high (ICC: 0.82-0.97). The assessment of the first part of this tool ranges from 0 to 100 points, where the higher the score, the greater the clinical severity of the patients.
4 secondary outcomes
Assessment of fear of movement at baseline
Time frame: Baseline
Assessment of catastrophising at baseline
Time frame: Baseline
Assessment of pain anxiety levels at baseline
Time frame: Baseline
Assessment of pressure pain threshold
Time frame: Screening visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- 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. This study is not recruiting at the moment.
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, 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 20 Feb 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 central pain sensitivity 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 20 Feb 2026.