HemophiliaNCT06281340
Changes in Intra-articular Parameters by Doppler Ultrasound in Patients With Hemophilic Ankle Arthropathy
A study testing Manual therapy in people with Hemophilia, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Introduction: Hemophilic ankle arthropathy is manifested by functional degenerative alterations, intra-articular alterations, and chronic pain. Manual therapy techniques are used in the treatment of hemophilic ankle arthropathy for the improvement of pain and mobility. Design. Double-blind randomized pilot trial. Read more about this study
- Who is it for?
- Ages 30 to 55 years, men only
- Conditions the study is for
- Hemophilia
- What is being tested?
- Manual therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 28 Feb 2024to 21 Apr 2024
- Phase
- Interventional
- 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 30 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with hemophilia A or B.
- Persons over 18 years of age.
- Patients with a medical diagnosis of ankle arthropathy (with clinical assessment of more than 4 points on the Hemophilia Joint Health Score.
- Patients on prophylactic or on-demand treatment with FVIII / FIX concentrates.
- Sign the informed consent document.
Who cannot join
- Patients with inhibitors (antibodies against FVIII or FIX) without treatment with monoclonal antibodies.
- Patients with neurological or cognitive alterations that impede the comprehension of questionnaires and physical tests.
- Patients who have developed an ankle hemarthrosis in the 3 months prior to the study.
- Patients who at the time of the study are receiving ankle physiotherapy treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Intra-articular Parameters by Doppler Ultrasound in Patients With Hemophilic Ankle Arthropathy After Manual Therapy Intervention: A Randomized Double-blind Clinical Study
Introduction: Hemophilic ankle arthropathy is manifested by functional degenerative alterations, intra-articular alterations, and chronic pain. Manual therapy techniques are used in the treatment of hemophilic ankle arthropathy for the improvement of pain and mobility.
Design. Double-blind randomized pilot trial. Aimed: To evaluate the ultrasound changes by means of Doppler imaging after manual therapy intervention.
Read more
Patients: A total of 20 adult patients with hemophilic ankle arthropathy will be recruited.
Intervention: Each manual therapy session will last approximately 50 minutes, with 1 session per week for a period of 3 weeks. The treatment program includes 10 techniques that will be administered bilaterally.
Measuring instruments: Patients will be evaluated qualitatively with ultrasound (HEAD-US scale) and assessment with Doppler ultrasound. The clinical variables will be joint damage (Hemophilia Joint Health Score) and pain intensity (Visual Analogue Scale).
Expected results: Check the safety of manual therapy in patients with hemophilia regarding subclinical bleeding. Assess changes related to joint inflammatory state with imaging techniques. Observe changes in pain intensity and joint damage.
- Conditions
- Hemophilia
- Being tested
- Manual therapy, Placebo manual therapy
- Keywords
- Hemophilia, Ankle, Manual therapy, Ultrasound, Joint pain, Joint damage
- Medical subject headings
- Hemophilia A, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
Each session will last approximately 50-60 minutes. Each session is composed of 10 techniques, 9 of which correspond to manual interventions commonly used in the field of manual therapy and adapted to patients with hemophilic arthropathy, according to the criteria previously established in studies that assess the safety of manual interventions in hemophilic arthropathy.
Placebo manual therapyOther
Each session will last approximately 50-60 minutes. Each session consists of the placebo application of 10 techniques, 9 of which correspond to manual interventions commonly used in the field of manual therapy and adapted to patients with hemophilic arthropathy, according to criteria previously established in studies that assess the safety of manual interventions in hemophilic arthropathy. In the techniques there will be no joint sliding, manipulations or myofascial inductions, being the only stimulus the contact of the physiotherapist with his hands and the pressure exerted with these, on the ankle.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The patients included in the experimental group will receive a session of manual physiotherapy using joint gliding techniques, myofascial and manipulative techniques of the tobioperoneoastotalar and subtalar joints. The intervention will be performed on both ankles. Receives: Other: Manual therapy |
| Control group | Placebo comparator | Patients included in the control group will receive a placebo manual physical therapy session, simulating joint sliding techniques, myofascial and manipulative techniques of the tobioperoneoastotalar and subtalar joints, without any stimulus other than the pressure exerted by the physical therapist with his hands when mobilizing the foot. The placebo intervention will be performed on both ankles. Receives: Other: Placebo manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline sonographic changes after 4 hours
Ultrasound changes will be measured with the Haemophilia Early Arthropathy Detection with UltraSound score. This scale evaluates two parameters: i) inflammatory activity (scores synovial hypertrophy from 0 to 2 points depending on whether involvement is identified); and ii) involvement of articular surfaces (assesses articular cartilage and bone involvement). In the assessment of articular cartilage, a score from 0 to 4 is established (0: normal; 4: complete destruction of cartilage or cannot be visualized). Bone is scored from 0 to 2 points (0: normal; 2: involvement with osteophytes).
Measured: Screening visit and after four hours follow-up
Secondary outcomes (3)
Change from baseline joint pain after 4 hours
The intensity of ankle joint pain will be measured with the visual analog scale. This scale has shown moderate reliability (ICC: 0.60-0.77) in patients with chronic musculoskeletal pain. Its scores range from 0 to 10 points (from no pain to the maximum pain perceived by the patient).
Measured: Screening visit and after four hours follow-up
Change from baseline joint damage after 4 hours
Joint damage will be measured with the Hemophilia Joint Health Score (HJHS). This measurement instrument will be used to assess the joint status of both ankles. It includes 8 items (swelling and duration of swelling, pain, muscle atrophy and strength, crepitus, and loss of flexion and extension) with a range of 0 to 20 points per joint (the higher the score, the greater the joint impairment).
Measured: Screening visit and after four hours follow-up
Change from baseline degree of joint inflammation after 4 hours
With a doppler assessment, a qualitative assessment of the degree of joint inflammation (semi-quantitative visual scale from 1 to 4: none, mild, moderate, severe) and a quantitative assessment by quantifying the resistance index (RI) will be performed
Measured: Screening visit and after four hours follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start28 Feb 2024
- Primary completion10 Apr 2024
- Study completion21 Apr 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad de Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281340
- Sponsor's protocol ID
- He-ankle US
- Status last verified
- May 2024
- First submitted
- 20 Feb 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Changes in Intra-articular Parameters by Doppler Ultrasound in Patients With Hemophilic Ankle Arthropathy After Manual Therapy Intervention: A Randomized Double-blind Clinical Study
- ClinicalTrials.gov ID
- NCT06281340
- Acronym / sponsor ID
- He-ankle US
- Conditions
- Hemophilia
- Keywords
- Hemophilia, Ankle, Manual therapy, Ultrasound, Joint pain, Joint damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 10 Apr 2024 (actual)
- Study completion
- 21 Apr 2024 (actual)
- First posted
- 28 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 ankle arthropathy is manifested by functional degenerative alterations, intra-articular alterations, and chronic pain. Manual therapy techniques are used in the treatment of hemophilic ankle arthropathy for the improvement of pain and mobility.
Design. Double-blind randomized pilot trial. Aimed: To evaluate the ultrasound changes by means of Doppler imaging after manual therapy intervention.
Patients: A total of 20 adult patients with hemophilic ankle arthropathy will be recruited.
Intervention: Each manual therapy session will last approximately 50 minutes, with 1 session per week for a period of 3 weeks. The treatment program includes 10 techniques that will be administered bilaterally.
Measuring instruments: Patients will be evaluated qualitatively with ultrasound (HEAD-US scale) and assessment with Doppler ultrasound. The clinical variables will be joint damage (Hemophilia Joint Health Score) and pain intensity (Visual Analogue Scale).
Expected results: Check the safety of manual therapy in patients with hemophilia regarding subclinical bleeding. Assess changes related to joint inflammatory state with imaging techniques. Observe changes in pain intensity and joint damage.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Manual therapyThe patients included in the experimental group will receive a session of manual physiotherapy using joint gliding techniques, myofascial and manipulative techniques of the tobioperoneoastotalar and subtalar joints. The intervention will be performed on both ankles. |
| Control group | Placebo comparator | Other: Placebo manual therapyPatients included in the control group will receive a placebo manual physical therapy session, simulating joint sliding techniques, myofascial and manipulative techniques of the tobioperoneoastotalar and subtalar joints, without any stimulus other than the pressure exerted by the physical therapist with his hands when mobilizing the foot. The placebo intervention will be performed on both ankles. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients diagnosed with hemophilia A or B.
- Persons over 18 years of age.
- Patients with a medical diagnosis of ankle arthropathy (with clinical assessment of more than 4 points on the Hemophilia Joint Health Score.
- Patients on prophylactic or on-demand treatment with FVIII / FIX concentrates.
- Sign the informed consent document.
Key exclusion criteria (4 listed)
- Patients with inhibitors (antibodies against FVIII or FIX) without treatment with monoclonal antibodies.
- Patients with neurological or cognitive alterations that impede the comprehension of questionnaires and physical tests.
- Patients who have developed an ankle hemarthrosis in the 3 months prior to the study.
- Patients who at the time of the study are receiving ankle physiotherapy treatment.
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 |
|---|---|---|
| Manual therapyEach session will last approximately 50-60 minutes. Each session is composed of 10 techniques, 9 of which correspond to manual interventions commonly used in the field of manual therapy and adapted to patients with hemophilic arthropathy, according to the criteria previously established in studies that assess the safety of manual interventions in hemophilic arthropathy. | Other | Experimental group |
| Placebo manual therapyEach session will last approximately 50-60 minutes. Each session consists of the placebo application of 10 techniques, 9 of which correspond to manual interventions commonly used in the field of manual therapy and adapted to patients with hemophilic arthropathy, according to criteria previously established in studies that assess the safety of manual interventions in hemophilic arthropathy. In the techniques there will be no joint sliding, manipulations or myofascial inductions, being the only stimulus the contact of the physiotherapist with his hands and the pressure exerted with these, on the ankle. | Other | Control group |
Primary outcome
Change from baseline sonographic changes after 4 hours
Time frame: Screening visit and after four hours follow-up
Ultrasound changes will be measured with the Haemophilia Early Arthropathy Detection with UltraSound score. This scale evaluates two parameters: i) inflammatory activity (scores synovial hypertrophy from 0 to 2 points depending on whether involvement is identified); and ii) involvement of articular surfaces (assesses articular cartilage and bone involvement). In the assessment of articular cartilage, a score from 0 to 4 is established (0: normal; 4: complete destruction of cartilage or cannot be visualized). Bone is scored from 0 to 2 points (0: normal; 2: involvement with osteophytes).
3 secondary outcomes
Change from baseline joint pain after 4 hours
Time frame: Screening visit and after four hours follow-up
Change from baseline joint damage after 4 hours
Time frame: Screening visit and after four hours follow-up
Change from baseline degree of joint inflammation after 4 hours
Time frame: Screening visit and after four hours follow-up
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 24 May 2024.
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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?
A study testing Manual therapy in people with 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 5 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 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. Some participants in this study may receive a placebo. 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?
Change from baseline sonographic changes after 4 hours (time frame: Screening visit and after four hours follow-up). 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.