HemophiliaNCT06267209
Conditioned Pain Modulation in Patients With Hemophilia
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 alterations, disabling physical sequelae, and chronic pain. Conditioned pain modulation describes the net effect of endogenous pathways that enhance or diminish the effects of afferent noxious stimuli. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men only
- Conditions the study is for
- Hemophilia
- What is being tested?
- Observational group
- How many people
- 51 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2024to 20 Jun 2024
- 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 20 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: A sample size of 51 patients with hemophilic ankle arthropathy has been estimated. The assessment will take place at the premises of the hemophilia Associations included in the study. All evaluations will be performed by the same physical therapist, following the same evaluation protocol. Given the characteristics of the study, the risks of bleeding in these patients during the evaluations should be minimized by designing a well-structured and justified protocol. Likewise, it should be emphasized that the study does not imply any change in the routines and medical management guidelines of the patient with respect to the usual clinical follow-up conditions, following the premises of the physician who usually attends the patient at his or her referral hospital.
Who may be able to join
- Patients diagnosed with hemophilia A or B.
- Patients over 18 years of age.
- Persons with a medical diagnosis of bilateral hemophilic ankle arthropathy.
- Patients with clinical assessment by Hemophilia Joint Health Score (>4 points).
- Persons with hemophilia on prophylactic treatment with FVIII / FIX coagulation concentrates or monoclonal antibodies.
- Have signed the informed consent document.
Who cannot join
- Patients with neurological or cognitive alterations that prevent the comprehension of the questionnaires and physical tests.
- Patients who have had an ankle hemarthrosis in the 6 months prior to the start of the study.
- Patients who have taken analgesic or anti-inflammatory drugs in the 30 days prior to the study.
- Patients who are undergoing an intervention (physiotherapeutic or orthopedic) at the time of the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Oviedo
Oviedo, Principality of Asturias, 33006
Rubén Cuesta-Barriuso, PhD
About this study
Official title: Conditioned Pain Modulation in Patients With Hemophilic Arthropathy. A Cross-sectional Cohort Study
Introduction: Hemophilic arthropathy is characterized by functional alterations, disabling physical sequelae, and chronic pain. Conditioned pain modulation describes the net effect of endogenous pathways that enhance or diminish the effects of afferent noxious stimuli.
Objectives: To describe conditioned pain modulation in patients with hemophilia and identify the best predictive model of conditioned pain modulation in these patients Methods: Cross-sectional cohort study. 51 patients with hemophilic arthropathy will be recruited in 3 regions of Spain. The main study variable will be the conditional pain modulation (Conditioned Pain Modulation Index, using an ischemic technique of the arm using the pain pressure threshold as a test stimulus), with age being the dependent variable. The secondary variables, estimated as modifying or confounding variables, will be kinesiophobia (Tampa Scale for Kinesiophobia), catastrophizing (Pain Catstrophizing Scale), trait and state anxiety (State-Trait Anxiety Inventory) and the main clinical, anthropometric, and sociodemographic.
Expected results: Identify the degree of modulation conditioned by pain in patients with hemophilic arthropathy. Identify the best predictive model for conditioned pain modulation in these patients based on the study variables
- Conditions
- Hemophilia
- Being tested
- Observational group
- Keywords
- Haemophilia, Joint pain, Conditioned pain modulation, Kinesiophobia, Catastrophism, Anxiety
- Medical subject headings
- Hemophilia A, Arthralgia, Kinesiophobia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational groupOther
After confirming that the patients not meet any of the exclusion criteria, dependent and confounding study variables will be assessed.
Patients will be recruited in 3 regions of Spain (Galicia, Madrid and Malaga), through the respective provincial associations and the Spanish Federation of Hemophilia.
The assessment will take place at the premises of the hemophilia associations included in the study. All the evaluations will be carried out by the same physiotherapist, following the same evaluation protocol.
The primary variable of the study will be the conditioned modulation of pain, being age the dependent variable. Secondary variables, estimated as modifiers or confounders, will be kinesiophobia, catastrophizing, anxiety perception, joint damage, pain intensity, functional capacity and pain threshold to pressure, and type of treatment and development of inhibitors.
| Study group | Role | What they receive |
|---|---|---|
| Observacional group | Patients will be recruited in 3 regions of Spain (Galicia, Madrid and Malaga), through the respective provincial associations and the Spanish Federation of Hemophilia.
The assessment will take place at the premises of the hemophilia associations included in the study. All the evaluations will be carried out by the same physiotherapist, following the same evaluation protocol.
The primary variable of the study will be the conditioned modulation of pain, being age the dependent variable. Secondary variables, estimated as modifiers or confounders, will be kinesiophobia, catastrophizing, anxiety perception, joint damage, pain intensity, functional capacity and pain threshold to pressure, and type of treatment and development of inhibitors. Receives: Other: Observational group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the Conditioned Pain Modulation Index
First, we will measure the pain threshold to pressure at the base of the dorsal part of the distal phalanx of the thumb, and then we will provoke the conditioned stimulus using the ischemia test on the contralateral upper limb. For the ischemia test, a sphygmomanometer will be used and inflated to 240 mmHg. The arm will be positioned horizontally. Patients will be asked to indicate the intensity of pain on a numerical pain rating scale until a pain rating of 7/10 appears. Patients will perform resistance exercises in wrist extension by lifting a 2 kg weight up to a maximum of 45 repetitions. With the sphygmomanometer still inflated, pain detection threshold measurements will be repeated at the dorsal aspect of the distal phalanx of the thumb. The time shall not be extended beyond six minutes.
Measured: Screening visit
Secondary outcomes (7)
Assess the kinesiophobia with Tampa Scale of Kinesiophofia
With the Tampa Scale of kinesiophobia (TSK-11SV) questionnaire, the fear of movement of the patients included in the study will be evaluated. It consists of 11 items. Its values have a range of 1 to 4 points, where the higher the score, the greater the fear of movement
Measured: Screening visit
Assess the catastrophizing with Pain catastrophizing scale
With the Pain catastrophizing scale questionnaire, the catastrophizing of patients with congenital coagulopathies will be measured. The scale, made up of 13 items, is assessed with a range of 0 to 4 points (lower score indicates less catastrophism).
Measured: Screening visit
Assess the catastrophizing with State-Trait Anxiety Inventory
With the State-Trait Anxiety Inventory (STAI) scale, the perception of anxiety of the patients included in the study will be measured. The state and the anxiety trait of each subject are evaluated with a score of 0 to 30 points for each scale, where a higher score indicates a higher anxiety index in the trait or state.
Measured: Screening visit
Assess the joint damage with Haemophilia Joint Health Score
With the Hemophilia Joint Health Score scale, specific for its use in patients with hemophilia, the joint status of patients with hemophilic arthropathy will be evaluated. It evaluates 8 items: inflammation and duration of this, pain, muscle atrophy and strength, crackles, and loss of flexion and extension. It has a score of 0 (no joint damage) to 20 points (maximum joint damage) per joint (elbows, knees and ankles). A gait rating is added to the 120 points (range 0-4 points), the maximum rating on this scale being 124 points
Measured: Screening visit
Assess the joint pain with visual analog scale
The visual analog scale will be used to assess the perception of joint pain, being valued with a range of 0 to 10 points (from no pain to the maximum pain suffered or imaginable) in the joints evaluated
Measured: Screening visit
Assess the pressure pain threshold with pressure algometer
With a pressure algometer (model Wagner FPN100) we will measure the pressure pain threshold, at the joint level and at a distance (in another part of the body). This device measures in Newton / cm2 the pressure at which the subject perceives pain under pressure. A pressure will be made on the chosen point, which we will increase at an approximate speed of 50kPa / s until the patient warns us that the sensation begins to be painful. We will be assessed in ankle (lateral malleolus, L5 spinous process, and extensor carpi longus muscle).
Measured: Screening visit
Assess the functional capacity with the 6-Minute Walking test
The 6-Minute Walking test is performance-based, measuring walking speed and submaximal exercise capacity. Patients are instructed to walk a 30 to 50 meter track for 6 minutes and try to cover as much distance as possible without running. The distance covered, in meters, in 6 minutes is recorded, allowing the use of a walking aid or orthosis.
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 posted20 Feb 2024
- Study start1 May 2024
- Primary completion3 Jun 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
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
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267209
- Sponsor's protocol ID
- He-Modulation
- Status last verified
- May 2024
- First submitted
- 12 Feb 2024
- Last updated
- 24 May 2024
- 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 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conditioned Pain Modulation in Patients With Hemophilic Arthropathy. A Cross-sectional Cohort Study
- ClinicalTrials.gov ID
- NCT06267209
- Acronym / sponsor ID
- He-Modulation
- Conditions
- Hemophilia
- Keywords
- Haemophilia, Joint pain, Conditioned pain modulation, Kinesiophobia, Catastrophism, Anxiety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 1 May 2024 (actual)
- Primary completion
- 3 Jun 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 20 Feb 2024 (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 alterations, disabling physical sequelae, and chronic pain. Conditioned pain modulation describes the net effect of endogenous pathways that enhance or diminish the effects of afferent noxious stimuli.
Objectives: To describe conditioned pain modulation in patients with hemophilia and identify the best predictive model of conditioned pain modulation in these patients Methods: Cross-sectional cohort study. 51 patients with hemophilic arthropathy will be recruited in 3 regions of Spain. The main study variable will be the conditional pain modulation (Conditioned Pain Modulation Index, using an ischemic technique of the arm using the pain pressure threshold as a test stimulus), with age being the dependent variable. The secondary variables, estimated as modifying or confounding variables, will be kinesiophobia (Tampa Scale for Kinesiophobia), catastrophizing (Pain Catstrophizing Scale), trait and state anxiety (State-Trait Anxiety Inventory) and the main clinical, anthropometric, and sociodemographic.
Expected results: Identify the degree of modulation conditioned by pain in patients with hemophilic arthropathy. Identify the best predictive model for conditioned pain modulation in these patients based on the study variables
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observacional group | – | Other: Observational groupPatients will be recruited in 3 regions of Spain (Galicia, Madrid and Malaga), through the respective provincial associations and the Spanish Federation of Hemophilia. The assessment will take place at the premises of the hemophilia associations included in the study. All the evaluations will be carried out by the same physiotherapist, following the same evaluation protocol. The primary variable of the study will be the conditioned modulation of pain, being age the dependent variable. Secondary variables, estimated as modifiers or confounders, will be kinesiophobia, catastrophizing, anxiety perception, joint damage, pain intensity, functional capacity and pain threshold to pressure, and type of treatment and development of inhibitors. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A sample size of 51 patients with hemophilic ankle arthropathy has been estimated. The assessment will take place at the premises of the hemophilia Associations included in the study. All evaluations will be performed by the same physical therapist, following the same evaluation protocol. Given the characteristics of the study, the risks of bleeding in these patients during the evaluations should be minimized by designing a well-structured and justified protocol. Likewise, it should be emphasized that the study does not imply any change in the routines and medical management guidelines of the patient with respect to the usual clinical follow-up conditions, following the premises of the physician who usually attends the patient at his or her referral hospital.
Key inclusion criteria (6 listed)
- Patients diagnosed with hemophilia A or B.
- Patients over 18 years of age.
- Persons with a medical diagnosis of bilateral hemophilic ankle arthropathy.
- Patients with clinical assessment by Hemophilia Joint Health Score (>4 points).
- Persons with hemophilia on prophylactic treatment with FVIII / FIX coagulation concentrates or monoclonal antibodies.
Key exclusion criteria (4 listed)
- Patients with neurological or cognitive alterations that prevent the comprehension of the questionnaires and physical tests.
- Patients who have had an ankle hemarthrosis in the 6 months prior to the start of the study.
- Patients who have taken analgesic or anti-inflammatory drugs in the 30 days prior to the study.
- Patients who are undergoing an intervention (physiotherapeutic or orthopedic) 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational groupAfter confirming that the patients not meet any of the exclusion criteria, dependent and confounding study variables will be assessed. Patients will be recruited in 3 regions of Spain (Galicia, Madrid and Malaga), through the respective provincial associations and the Spanish Federation of Hemophilia. The assessment will take place at the premises of the hemophilia associations included in the study. All the evaluations will be carried out by the same physiotherapist, following the same evaluation protocol. The primary variable of the study will be the conditioned modulation of pain, being age the dependent variable. Secondary variables, estimated as modifiers or confounders, will be kinesiophobia, catastrophizing, anxiety perception, joint damage, pain intensity, functional capacity and pain threshold to pressure, and type of treatment and development of inhibitors. | Other | Observacional group |
Primary outcome
Assess the Conditioned Pain Modulation Index
Time frame: Screening visit
First, we will measure the pain threshold to pressure at the base of the dorsal part of the distal phalanx of the thumb, and then we will provoke the conditioned stimulus using the ischemia test on the contralateral upper limb. For the ischemia test, a sphygmomanometer will be used and inflated to 240 mmHg. The arm will be positioned horizontally. Patients will be asked to indicate the intensity of pain on a numerical pain rating scale until a pain rating of 7/10 appears. Patients will perform resistance exercises in wrist extension by lifting a 2 kg weight up to a maximum of 45 repetitions. With the sphygmomanometer still inflated, pain detection threshold measurements will be repeated at the dorsal aspect of the distal phalanx of the thumb. The time shall not be extended beyond six minutes.
7 secondary outcomes
Assess the kinesiophobia with Tampa Scale of Kinesiophofia
Time frame: Screening visit
Assess the catastrophizing with Pain catastrophizing scale
Time frame: Screening visit
Assess the catastrophizing with State-Trait Anxiety Inventory
Time frame: Screening visit
Assess the joint damage with Haemophilia Joint Health Score
Time frame: Screening visit
Assess the joint pain with visual analog scale
Time frame: Screening visit
Assess the pressure pain threshold with pressure algometer
Time frame: Screening visit
Assess the functional capacity with the 6-Minute Walking test
Time frame: Screening visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- 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.
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: status not confirmed, as of the sponsor's last update on 24 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rubén Cuesta-Barriuso, PhD (607547274, cuestaruben@uniovi.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the Conditioned Pain Modulation Index (time frame: Screening visit). 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 24 May 2024.