HemophiliaHe-FascialNCT02433782
Myofascial Therapy in Patients With Hemophilic Arthropathy
A study testing Myofascial therapy in people with Hemophilia, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Designing a treatment protocol using myofascial therapy for the treatment of pain and restrictions on mobility in patients with hemophilic arthropathy of the knee and ankle. Pilot with a small number of patients for assessment the effectiveness and safety of the treatment protocol created. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Hemophilia
- What is being tested?
- Myofascial therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2015to Dec 2015
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of hemophilia A and B.
- Patients older than 18 years.
- Patients with a diagnosis of hemophilic arthropathy of the knee and ankle.
- Patients on prophylactic regimen with FVIII / FIX.
Who cannot join
- Patients without walking ability.
- Patients with a diagnosis of other congenital coagulopathy (eg von Willebrand disease).
- Patients who have developed antibodies to FVIII / FIX (inhibitors).
- Patients with neurological or cognitive impairments that impede understanding of questionnaires and physical test.
- Patients who have not signed the informed consent document.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad Católica San Antonio, Murcia
Murcia, Murcia, 30107
RUBEN CUESTA-BARRIUSO, PhD, +34 968278545, rcuesta@ucam.edu
About this study
Official title: Physiotherapy Protocol by Myofascial Therapy and Randomized Clinical Study in Patients With Hemophilic Arthropathy
Designing a treatment protocol using myofascial therapy for the treatment of pain and restrictions on mobility in patients with hemophilic arthropathy of the knee and ankle.
Pilot with a small number of patients for assessment the effectiveness and safety of the treatment protocol created.
Randomized clinical trial to assess the effectiveness of treatment with myofascial therapy in patients with hemophilia.
Describe the differences in terms of the dependent variables (range of motion, pain and flexibility) in patients with hemophilia who have carried out the treatment.
Report the relationship between the clinical characteristics of patients and the results obtained after the treatment period.
Read the detailed description
Phase I pilot study with 5 patients with hemophilia for assessment by myofascial therapy protocol designed for this purpose.
Phase II. Randomized, prospective longitudinal clinical study in patients with hemophilia, to assess the efficacy of an intervention with myofascial therapy.
- Conditions
- Hemophilia
- Being tested
- Myofascial therapy
- Keywords
- Haemophilia, Arthropathy, Pain, Range of motion, Miofascial techniques
- Medical subject headings
- Hemophilia A, Joint Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial therapyOther
Maneuver of pressure and sliding over the anterolateral compartment of the leg Maneuver of pressure and sliding on the back of the leg Liberation technique of the popliteal fascia Maneuver of pressure and sliding on the anterior thigh Maneuver of pressure and sliding on the iliotibial tract Maneuver of pressure and sliding on the hamstring muscle region. Induction maneuver of ankle anterior compartment Induction maneuver of knee anterior chamber
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Treatment through myofascial therapy for the treatment of pain and restricted mobility in patients with hemophilic arthropathy of the knee and ankle Receives: Other: Myofascial therapy |
| Control group | No intervention | No myofascial intervention. Patients continue their treatment with FVIII or FIX concentrates, normally |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding frequency
Change from number of bleeding during treatment and follow-up period at 1 month
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (3)
Pain
Change from joint pain during treatment and follow-up period at 1 month
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Joint function
Change from joint health during treatment and follow-up period at 1 month. Haemophilia Joint Health. Measurement instrument: Score and Gilbert score
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Range of motion
Change from range of movement of ankle and knee during treatment and follow-up period at 1 month. Measurement instrument: universal goniometer with the protocol to measurement for patients with hemophilia
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubén Cuesta-Barriuso, PhD, Universidad Católica San Antonio de Murcia
- Investigators
- JAVIER MEROÑO-GALLUT, PhD, Study chair, Universidad Católica San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433782
- Sponsor's protocol ID
- He-Fascial
- Acronym
- He-Fascial
- Status last verified
- Sep 2015
- First submitted
- 27 Apr 2015
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy Protocol by Myofascial Therapy and Randomized Clinical Study in Patients With Hemophilic Arthropathy
- ClinicalTrials.gov ID
- NCT02433782
- Acronym / sponsor ID
- He-Fascial / He-Fascial
- Conditions
- Hemophilia
- Keywords
- Haemophilia, Arthropathy, Pain, Range of motion, Miofascial techniques
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 5 May 2015 (estimated)
- 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.
Designing a treatment protocol using myofascial therapy for the treatment of pain and restrictions on mobility in patients with hemophilic arthropathy of the knee and ankle.
Pilot with a small number of patients for assessment the effectiveness and safety of the treatment protocol created.
Randomized clinical trial to assess the effectiveness of treatment with myofascial therapy in patients with hemophilia.
Describe the differences in terms of the dependent variables (range of motion, pain and flexibility) in patients with hemophilia who have carried out the treatment.
Report the relationship between the clinical characteristics of patients and the results obtained after the treatment period.
Detailed description
Phase I pilot study with 5 patients with hemophilia for assessment by myofascial therapy protocol designed for this purpose.
Phase II. Randomized, prospective longitudinal clinical study in patients with hemophilia, to assess the efficacy of an intervention with myofascial therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Myofascial therapyTreatment through myofascial therapy for the treatment of pain and restricted mobility in patients with hemophilic arthropathy of the knee and ankle |
| Control group | No intervention | –No myofascial intervention. Patients continue their treatment with FVIII or FIX concentrates, normally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a diagnosis of hemophilia A and B.
- Patients older than 18 years.
- Patients with a diagnosis of hemophilic arthropathy of the knee and ankle.
- Patients on prophylactic regimen with FVIII / FIX.
Key exclusion criteria (5 listed)
- Patients without walking ability.
- Patients with a diagnosis of other congenital coagulopathy (eg von Willebrand disease).
- Patients who have developed antibodies to FVIII / FIX (inhibitors).
- Patients with neurological or cognitive impairments that impede understanding of questionnaires and physical test.
- Patients who have not 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 |
|---|---|---|
| Myofascial therapyManeuver of pressure and sliding over the anterolateral compartment of the leg Maneuver of pressure and sliding on the back of the leg Liberation technique of the popliteal fascia Maneuver of pressure and sliding on the anterior thigh Maneuver of pressure and sliding on the iliotibial tract Maneuver of pressure and sliding on the hamstring muscle region. Induction maneuver of ankle anterior compartment Induction maneuver of knee anterior chamber | Other | Experimental group |
Primary outcome
Bleeding frequency
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from number of bleeding during treatment and follow-up period at 1 month
3 secondary outcomes
Pain
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Joint function
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Range of motion
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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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.
JAVIER MEROÑO-GALLUT, PhD study chair
Universidad Católica San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial therapy in people with Hemophilia, run by Universidad Católica San Antonio de Murcia 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 4 inclusion and 5 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 14 Oct 2015. 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 RUBEN CUESTA-BARRIUSO, PhD (+34 968278545, ruben.cuestab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding frequency (time frame: Screening visit, within the first seven days after treatment and after one month follow-up 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 14 Oct 2015.