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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Control group | No Intervention | No myofascial intervention. Patients continue their treatment with FVIII or FIX concentrates, normally |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myofascial therapy | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding frequency | Change from number of bleeding during treatment and follow-up period at 1 month | Screening visit, within the first seven days after treatment and after one month follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Change from joint pain during treatment and follow-up period at 1 month | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| RUBEN CUESTA-BARRIUSO, PhD | Contact | +34 968278545 | ruben.cuestab@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| JAVIER MEROÑO-GALLUT, PhD | Universidad Católica San Antonio | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Católica San Antonio, Murcia | Recruiting | Murcia | Murcia | 30107 | Spain |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 29, 2016 | |
| Unrelease | Yes | |
| Release | Jul 6, 2016 | |
| Reset | Aug 16, 2016 | |
| Release | Aug 26, 2016 | |
| Reset | Oct 19, 2016 | |
| Release | Dec 30, 2016 | |
| Reset | Feb 21, 2017 | |
| Release | Sep 26, 2017 | |
| Reset | Jul 12, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 29, 2016 | Yes | |||
| Jul 6, 2016 |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D007592 | Joint Diseases |
| D010146 | Pain |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000089803 | Myofascial Release Therapy |
| ID | Term |
|---|---|
| D008405 | Massage |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
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|
| 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 | Screening visit, within the first seven days after treatment and after one month follow-up visit |
| Aug 16, 2016 |
| Aug 26, 2016 | Oct 19, 2016 |
| Dec 30, 2016 | Feb 21, 2017 |
| Sep 26, 2017 | Jul 12, 2018 |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |