Hemophilia ArthropathyNCT05589662
Clinical, Functional and Musculoskeletal Differences Between Adult Patients With Hemophilia and Their Healthy Peers
An observational study of Hemophilia Arthropathy, run by Investigación en Hemofilia y Fisioterapia.
Trial summary
Background. Hemophilia is characterized by the development of a progressive, degenerative, intra-articular lesion (hemophilic arthropathy). This arthropathy presents with chronic pain, limited range of motion, axial changes, and periarticular muscle atrophy. Goal. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Hemophilia Arthropathy
- What is being tested?
- Clinical and functional assessment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 21 Nov 2022to 23 Dec 2022
- 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 to 45 years
- Men only
- Adult
Study population: Patients with hemophilic arthropathy and their healthy pairs
Who may be able to join
- Patients diagnosed with hemophilia A and B.
- Over 18 years
- With medical diagnosis of knee arthropathy
- With clinical evaluation by Hemophilia Joint Health Score
- In prophylactic treatment or on demand with FVIII / FIX concentrates for coagulation.
- Healthy subjects must meet knee joint health criteria; over 18 years; and no previous knee or ankle injuries in the 6 months prior to evaluation.
Who cannot join
- Patients with neurological or cognitive disorders that prevent the understanding of physical tests
- Not having signed the informed consent document
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Analysis of Clinical, Functional and Musculoskeletal Variables Between Adult Patients With Hemophilic Arthropathy of the Knee and Ankle and Their Healthy Peers. A Case-control Study
Background. Hemophilia is characterized by the development of a progressive, degenerative, intra-articular lesion (hemophilic arthropathy). This arthropathy presents with chronic pain, limited range of motion, axial changes, and periarticular muscle atrophy.
Goal. To analyze the clonic, functional and musculoskeletal differences between adult patients with hemophilic arthropathy of the knee and ankle and their healthy peers.
Read more
Study design. Cases and controls study patients. 21 patients with hemophilia A and B and 21 subjects without joint damage.
Variables and measuring instruments: pressure pain threshold (pressure algometer); joint status (Hemophilia Joint Health Score scale); and strength (dynamometry) and muscle activation (surface electromyography).
Expected results. Observe the differences between patients with knee and ankle arthropathy and their healthy peers in muscle strength and activation.
- Conditions
- Hemophilia Arthropathy
- Being tested
- Clinical and functional assessment
- Keywords
- Hemophilic arthropathy, Ankle, Knee, Strength, Muscle activation, Pressure pain threshold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and functional assessmentOther
The dependent variables (muscle strength, muscle activation, pressure pain threshold and joint status) and the outcome measures used to measure these variables will be: pressure dynamometer, surface electromyography, pressure algometer and Hemophilia Joint Health Score
| Study group | Role | What they receive |
|---|---|---|
| Hemophilia group | Patients with hemophilia, older than 18 years, with a diagnosis of hemophilic arthropathy of the knee and ankle. The different study variables will be evaluated following the indicated protocol. Receives: Other: Clinical and functional assessment | |
| Healthy peers.group | Healthy subjects, older than 18 years, without joint damage at the time of the study, and physically active. The different study variables will be evaluated following the indicated protocol. Receives: Other: Clinical and functional assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the muscle strength
The force will be measured with a pressure dynamometer (Lafayette Manual muscle Tester model 01165). This device measures in Newton the force exerted by the patient in the requested muscular action. The higher the value, the greater muscle strength. We will perform the measurements bilaterally. Strength in the quadriceps and triceps surae muscles will be measured. The patient will be asked for 2 maximum isometric contractions of 5 seconds, with a rest of 30 seconds between them. In all the measurements, the evaluator will encourage the patient in a standardized way to carry out the contractions. In the measurement of the strength of all the muscles evaluated, the mean value of the measurements obtained will be used as a measure.
Measured: Screening visit
Secondary outcomes (3)
Assess the muscle activation
Muscle activation will be measured with surface electromyography (Shimmer Sensing model, Dublin, Ireland). Using this instrument, we will evaluate the electrical activity of the muscles and their level of activation. The placement of the electrodes will be marked on the subjects standing, and they will be placed following the European recommendations for the use of SEMG. A bipolar SEMG system will be used with circular electrodes 10 mm in diameter, 20 mm apart, placed longitudinally, in the direction of the muscle fibers studied, and with a reference electrode at a distance. The unit of measure is the μV. The higher the score, the greater muscle activation.
Measured: Screening visit
Assess the pressure pain threshold
Pressure pain threshold will be measured with a pressure algometer (Wagner FPIXTM Digital Algometer model). This device measures in Newton/cm2 the pressure at which the subject perceives pressure pain. A pressure will be applied that we will increase at an approximate speed of 50kPa/s until the patient tells us that the sensation is beginning to be painful. In the knee we will measure bilaterally 3 cm medially to the midpoint of the inner edge of the patella, 2 cm proximally to the superior pole of the patella. At the ankle we will measure bilaterally ventrally to the lateral malleolus.
Measured: Screening visit
Assess the joint status
In patients with hemophilia, joint status will be assessed with the Hemophilia Joint Health Score. This specific scale for use in patients with hemophilia is used to measure the joint status of patients with hemophilic arthropathy. It evaluates 8 items: inflammation and its duration, 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 120 points (range 0-4 points), with the maximum rating on this scale being 124 points.
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 posted21 Oct 2022
- Study start21 Nov 2022 (estimated)
- Primary completion28 Nov 2022 (estimated)
- Study completion23 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia ArthropathyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589662
- Sponsor's protocol ID
- He-BloodCC
- Status last verified
- Nov 2022
- First submitted
- 18 Oct 2022
- Last updated
- 4 Nov 2022
- 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 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Clinical, Functional and Musculoskeletal Variables Between Adult Patients With Hemophilic Arthropathy of the Knee and Ankle and Their Healthy Peers. A Case-control Study
- ClinicalTrials.gov ID
- NCT05589662
- Acronym / sponsor ID
- He-BloodCC
- Conditions
- Hemophilia Arthropathy
- Keywords
- Hemophilic arthropathy, Ankle, Knee, Strength, Muscle activation, Pressure pain threshold
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 21 Nov 2022 (estimated)
- Primary completion
- 28 Nov 2022 (estimated)
- Study completion
- 23 Dec 2022 (estimated)
- First posted
- 21 Oct 2022 (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.
Background. Hemophilia is characterized by the development of a progressive, degenerative, intra-articular lesion (hemophilic arthropathy). This arthropathy presents with chronic pain, limited range of motion, axial changes, and periarticular muscle atrophy.
Goal. To analyze the clonic, functional and musculoskeletal differences between adult patients with hemophilic arthropathy of the knee and ankle and their healthy peers.
Study design. Cases and controls study patients. 21 patients with hemophilia A and B and 21 subjects without joint damage.
Variables and measuring instruments: pressure pain threshold (pressure algometer); joint status (Hemophilia Joint Health Score scale); and strength (dynamometry) and muscle activation (surface electromyography).
Expected results. Observe the differences between patients with knee and ankle arthropathy and their healthy peers in muscle strength and activation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemophilia group | – | Other: Clinical and functional assessmentPatients with hemophilia, older than 18 years, with a diagnosis of hemophilic arthropathy of the knee and ankle. The different study variables will be evaluated following the indicated protocol. |
| Healthy peers.group | – | Other: Clinical and functional assessmentHealthy subjects, older than 18 years, without joint damage at the time of the study, and physically active. The different study variables will be evaluated following the indicated protocol. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- Patients with hemophilic arthropathy and their healthy pairs
Key inclusion criteria (6 listed)
- Patients diagnosed with hemophilia A and B.
- Over 18 years
- With medical diagnosis of knee arthropathy
- With clinical evaluation by Hemophilia Joint Health Score
- In prophylactic treatment or on demand with FVIII / FIX concentrates for coagulation.
Key exclusion criteria (2 listed)
- Patients with neurological or cognitive disorders that prevent the understanding of physical tests
- Not having signed the informed consent document
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 |
|---|---|---|
| Clinical and functional assessmentThe dependent variables (muscle strength, muscle activation, pressure pain threshold and joint status) and the outcome measures used to measure these variables will be: pressure dynamometer, surface electromyography, pressure algometer and Hemophilia Joint Health Score | Other | Healthy peers.group, Hemophilia group |
Primary outcome
Assess the muscle strength
Time frame: Screening visit
The force will be measured with a pressure dynamometer (Lafayette Manual muscle Tester model 01165). This device measures in Newton the force exerted by the patient in the requested muscular action. The higher the value, the greater muscle strength. We will perform the measurements bilaterally. Strength in the quadriceps and triceps surae muscles will be measured. The patient will be asked for 2 maximum isometric contractions of 5 seconds, with a rest of 30 seconds between them. In all the measurements, the evaluator will encourage the patient in a standardized way to carry out the contractions. In the measurement of the strength of all the muscles evaluated, the mean value of the measurements obtained will be used as a measure.
3 secondary outcomes
Assess the muscle activation
Time frame: Screening visit
Assess the pressure pain threshold
Time frame: Screening visit
Assess the joint status
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 4 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Hemophilia Arthropathy
Enrolling by invitation
3D Ultrasound in Hemophilic Ankles
Hemophilia
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Identification of New Biomarkers in Haemophilic Arthropathy Through Transcriptome Analysis
Hemophilia A and B
Not yet recruiting
Multicomponent Pain Self-Management in Adults With Haemophilic Arthropathy
Hemophilic Arthropathy, Chronic Pain
Active, not recruitingObservational study
A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A in Taiwan
Hemophilia A
Not yet recruiting
Ultrasound Assessment of Joint Health in Patients With Mild Hemophilia (Factor Levels 5-40%)
Mild Hemophilia
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
University of Oviedo
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia Arthropathy, run by Investigación en Hemofilia y Fisioterapia.
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 2 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 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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 (0034985103386, 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 muscle strength (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 4 Nov 2022.