HemophiliaNCT05549843
Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle
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 degenerative functional alterations (deficit of muscle strength, mobility and proprioception), intra-articular alterations and chronic pain. Manual therapy techniques are used to treat soft tissue adhesions, relieve pain and reduce tissue sensitivity. Design. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hemophilia
- What is being tested?
- Manual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 14 Oct 2022to 26 Feb 2023
- 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 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients diagnosed with hemophilia A and B
- With severe (<1% FVIII/FIX) or moderate (1-5% FVIII/FIX) phenotype of hemophilia
- Over 18 years
- With medical diagnosis of ankle arthropathy and with clinical evaluation by Hemophilia Joint Health Score
- In prophylactic treatment with FVIII / FIX concentrates for coagulation
Who cannot join
- Patients with inhibitors (antibodies against FVIII or FIX)
- Patients with neurological or cognitive disorders that prevent the understanding of questionnaires and physical tests
- Failure to sign the informed consent document
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle. A Pilot Study
Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscle strength, mobility and proprioception), intra-articular alterations and chronic pain. Manual therapy techniques are used to treat soft tissue adhesions, relieve pain and reduce tissue sensitivity.
Design. randomized pilot trial. Aimed: To evaluate the safety and effectiveness of a protocol by manual therapy techniques in patients with hemophilic ankle arthropathy.
Read more
Patients: 24 patients with ankle arthropathy will be recruited for inclusion in the study. Patients will be recruited in seven centers, from different regions of Spain.
Intervention: Each session will last approximately 50-60 minutes, with 1 physiotherapy session per week for a period of 3 weeks. Patients will be evaluated at baseline, after the intervention, and after a follow-up period of 3 weeks. The treatment program includes 10 exercises that must be administered bilaterally.
Measuring instruments and study variables: Visual Analog Scale and pressure algometer (joint pain); Leg motion (ankle range of motion); and Haemophilia Joint Health Score (joint health). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment.
Expected results: To demonstrate the safety of this Physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, joint motion, joint health and pressure pain threshold.
- Conditions
- Hemophilia
- Being tested
- Manual therapy
- Medical subject headings
- Hemophilia A
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, with 1 physiotherapy session per week over a period of 3 weeks. Each session is made up of 10 steps, of which 9 correspond to manual interventions commonly used in the field of manual therapy.
| Study group | Role | What they receive |
|---|---|---|
| Hemophilia group | Experimental | Intervention protocol:
* Preparatory work: active mobilizations with the patient supine.
* Global passive mobilization of the forefoot and midfoot.
* Calcaneocuboid mobilization, functional and structural work of said joint.
* Astragaloscaphoid mobilization, functional and structural work of said joint.
* Talar manipulation dorsally.
* Manipulation-tibial displacement:
* Tibiotarsal decompression: 2 very gentle high-speed and short-course tibial-tarsal manipulations.
* Plantar fascia induction for foot captors of the plantar fascia.
* Tibiotarsal sustained traction technique (unwinding)
* Sural triceps induction technique: Receives: Other: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline frequency of ankle hemarthrosis after treatment and at 3 weeks
Weekly follow-up by telephone calls in the experimental phase. The evaluator will conduct a survey with closed questions and answers on the clinical manifestations of hemarthrosis to rule out joint or muscle bleeding. The frequency of hemarthrosis will be measured with the total number of bleedings in the study period in each evaluation.
Measured: Screening visit, within the first seven days after treatment and after two months follow-up
Secondary outcomes (4)
Change from baseline ankle joint pain after treatment and at 3 weeks
Visual analogic scale (VAS). This scale will be used to evaluate the perception of joint pain, where ankle joint pain ranges from 0 to 10 points (no pain to maximum perceived pain).
Measured: Screening visit, within the first seven days after treatment and after two months follow-up
Change from baseline pressure pain threshold of ankle after treatment and at 3 weeks
Pressure algometer. Measuring instrument used to evaluate pressure joint pain. The instrument shall consist of a measuring device attached to a hard rubber tip 1.1 cm in diameter. Its sphere shall be calibrated in kg/cm2 with divisions of 0.1 kg/cm2. The pressure algometry methodology applied was based mainly on the study by Hogeweg.
Before taking the measurements, patients will be instructed to say "yes" as soon as pressure exerted by the algometer becomes slightly unpleasant. The pressure algometer shall be kept perpendicular to the surface of the skin with the right hand, stabilizing the axis of the instrument using the thumb and index finger of the left hand. The pressure shall be increased at a uniform rate of approximately 1 kg/cm2 per second. As soon as the subject, according to the instructions, says "yes", the pressure will be stopped and the score will be noted.
Measured: Screening visit, within the first seven days after treatment and after two months follow-up
Change from baseline ankle joint damage after treatment and at 3 weeks
Hemophilia Joint Health Score (HJHS). This measuring instrument will be used to evaluate the joint condition of ankles. It includes 8 items (inflammation and its duration, pain, atrophy and muscle strength, crepitus, and reduced flexion and extension) ranging from 0 to 20 points per joint (the higher the score, the greater the joint deterioration).
Measured: Screening visit, within the first seven days after treatment and after two months follow-up
Change from baseline ankle range of motion after treatment and at 3 weeks
Leg motion device. The test will be conducted in accordance with the procedures for conducting the weight-bearing lunge test. The subjects will stand to assess, in the Leg Motion system, with the big toe on the starting line and the knee touching a metal stick. While patients hold the position, they will be instructed on how to perform a lunge in which the knee will be flexed with the aim of touching a metal rod with its anterior part. The metal rod will move away from the foot up to the maximum ankle dorsiflexion allowed, without taking the heel off the ground and with knee contact on the rod. Maximum dorsiflexion ROM will be defined as the maximum distance from the toe to the metal rod while maintaining contact with the knee for three seconds, without lifting the heel. Three measurements will be made for each ankle and the mean value will be used for data analysis. All measurements will be made with the patient barefoot, first with one leg and then with the contralateral leg.
Measured: Screening visit, within the first seven days after treatment and after two months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start14 Oct 2022
- Primary completion18 Nov 2022
- Study completion26 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549843
- Sponsor's protocol ID
- He-AnklePilot
- Status last verified
- Feb 2024
- First submitted
- 19 Sep 2022
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Truque-Diaz C, Merono-Gallut J, Cuesta-Barriuso R, Perez-Llanes R. Joint and Myofascial Manual Therapy Techniques in Haemophilic Ankle Arthropathy: A Randomized Pilot Study. Haemophilia. 2025 Mar;31(2):295-303. doi: 10.1111/hae.70002. Epub 2025 Feb 7.
PubMed 39917949
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle. A Pilot Study
- ClinicalTrials.gov ID
- NCT05549843
- Acronym / sponsor ID
- He-AnklePilot
- Conditions
- Hemophilia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 26 Feb 2023 (actual)
- First posted
- 22 Sep 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.
Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscle strength, mobility and proprioception), intra-articular alterations and chronic pain. Manual therapy techniques are used to treat soft tissue adhesions, relieve pain and reduce tissue sensitivity.
Design. randomized pilot trial. Aimed: To evaluate the safety and effectiveness of a protocol by manual therapy techniques in patients with hemophilic ankle arthropathy.
Patients: 24 patients with ankle arthropathy will be recruited for inclusion in the study. Patients will be recruited in seven centers, from different regions of Spain.
Intervention: Each session will last approximately 50-60 minutes, with 1 physiotherapy session per week for a period of 3 weeks. Patients will be evaluated at baseline, after the intervention, and after a follow-up period of 3 weeks. The treatment program includes 10 exercises that must be administered bilaterally.
Measuring instruments and study variables: Visual Analog Scale and pressure algometer (joint pain); Leg motion (ankle range of motion); and Haemophilia Joint Health Score (joint health). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment.
Expected results: To demonstrate the safety of this Physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, joint motion, joint health and pressure pain threshold.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemophilia group | Experimental | Other: Manual therapyIntervention protocol: * Preparatory work: active mobilizations with the patient supine. * Global passive mobilization of the forefoot and midfoot. * Calcaneocuboid mobilization, functional and structural work of said joint. * Astragaloscaphoid mobilization, functional and structural work of said joint. * Talar manipulation dorsally. * Manipulation-tibial displacement: * Tibiotarsal decompression: 2 very gentle high-speed and short-course tibial-tarsal manipulations. * Plantar fascia induction for foot captors of the plantar fascia. * Tibiotarsal sustained traction technique (unwinding) * Sural triceps induction technique: |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients diagnosed with hemophilia A and B
- With severe (<1% FVIII/FIX) or moderate (1-5% FVIII/FIX) phenotype of hemophilia
- Over 18 years
- With medical diagnosis of ankle arthropathy and with clinical evaluation by Hemophilia Joint Health Score
- In prophylactic treatment with FVIII / FIX concentrates for coagulation
Key exclusion criteria (3 listed)
- Patients with inhibitors (antibodies against FVIII or FIX)
- Patients with neurological or cognitive disorders that prevent the understanding of questionnaires and physical tests
- Failure to sign 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 |
|---|---|---|
| Manual therapyEach session will last approximately 50-60 minutes, with 1 physiotherapy session per week over a period of 3 weeks. Each session is made up of 10 steps, of which 9 correspond to manual interventions commonly used in the field of manual therapy. | Other | Hemophilia group |
Primary outcome
Change from baseline frequency of ankle hemarthrosis after treatment and at 3 weeks
Time frame: Screening visit, within the first seven days after treatment and after two months follow-up
Weekly follow-up by telephone calls in the experimental phase. The evaluator will conduct a survey with closed questions and answers on the clinical manifestations of hemarthrosis to rule out joint or muscle bleeding. The frequency of hemarthrosis will be measured with the total number of bleedings in the study period in each evaluation.
4 secondary outcomes
Change from baseline ankle joint pain after treatment and at 3 weeks
Time frame: Screening visit, within the first seven days after treatment and after two months follow-up
Change from baseline pressure pain threshold of ankle after treatment and at 3 weeks
Time frame: Screening visit, within the first seven days after treatment and after two months follow-up
Change from baseline ankle joint damage after treatment and at 3 weeks
Time frame: Screening visit, within the first seven days after treatment and after two months follow-up
Change from baseline ankle range of motion after treatment and at 3 weeks
Time frame: Screening visit, within the first seven days after treatment and after two months 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 9 Feb 2024.
- Derived from this study: PubMed 39917949Truque-Diaz C, Merono-Gallut J, Cuesta-Barriuso R, Perez-Llanes R. Joint and Myofascial Manual Therapy Techniques in Haemophilic Ankle Arthropathy: A Randomized Pilot Study. Haemophilia. 2025 Mar;31(2):295-303. doi: 10.1111/hae.70002. Epub 2025 Feb 7.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 3 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 9 Feb 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?
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 frequency of ankle hemarthrosis after treatment and at 3 weeks (time frame: Screening visit, within the first seven days after treatment and after two months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05549843, which also lists 1 linked publication.
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 9 Feb 2024.