Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Introduction: The common clinical manifestations of hemophilia are skeletal muscle bleeds, especially hematomas and hemarthrosis. Repeated episodes of joint bleeding in certain joints, causing a progressive joint deterioration. Secondary disorders to this joint degeneration include: biomechanical alterations, loss of range of movement and periarticular muscle atrophy.
Design. A prospective, multicenter and longitudinal pilot study to evaluate the efficacy of a treatment protocol with fascial therapy applied in patients with hemophilic arthropathy of the elbow.
Aimed: To evaluate the safety and efficacy of a physiotherapy treatment by fascial therapy in patients with hemophilic arthropathy of the elbow Patients: A total of 60 patients with hemophilia and prophylactic treatment will be recruited for inclusion in the study. Patients will be recruited in 6 centers, from different regions of Spain.
Intervention: Each session will last approximately 50 minutes, with three physiotherapy sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers that must be administered bilaterally:
Measuring instruments and study variables: goniometric evaluation (range of movement); visual analog scale (joint pain); Haemophilia Joint Health Score (joint status); DASH Questionnaire (functionality of upper limbs); SF-36 Questionnaire (perception of quality of life). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment.
Expected results: First, it is intended to demonstrate the safety of this physiotherapy technique in patients with hemophilia. Likewise, an improvement in the perception of elbow pain and joint mobility is expected. An improved functionality of the upper limb is also foreseen and with it, an enhanced perception of quality of life of these patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expermiental group | Experimental | All patients included in the experimental group should be on prophylactic treatment with FVIII / FIX concentrates. Likewise, the factor should be administered on the same day that they receive each of the fascial therapy treatment sessions. Each session will last approximately 50 minutes, with three physiotherapy sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers that must be administered bilaterally: |
|
| Control group | No Intervention | Subjects included in the control group will not receive physical therapy through fascial therapy and will continue with their usual routine of physical activity and exercise, and with the same pharmacological treatment regimen with FVIII / FIX. At the end of the study period the intervention will be applied under the same conditions as the experimental group, analyzing the overall sample at the end of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental group | Other | Longitudinal surface sliding maneuver over the superficial fascia in the anterior region of the arm and the forearm. Applied in 3 strokes.
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline elbow joint bleeding frequency after treatment and at 3 months | After the first session of physiotherapy patients will be given a self-register where they can record all the observations they feel (from hematomas or hemarthros, to any other discomfort or perception). Similarly, the principal investigator of the study will monitor all patients within 48 hours after each physical therapy session. | Screening visit, within the first seven days after treatment and after three months follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline range of motion of elbow after treatment and at 3 months | Change from range of movement of elbow during treatment and follow-up period at 3 months. The range of motion of the elbow joint will be measured using a universal goniometer, using the protocol for measuring joint motion described by Felipe Querol. Measurement instrument: universal goniometer with the protocol to measurement for patients with hemophilia |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Victoria Eugenia Foundation | Madrid | Madird | 28029 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35081366 | Derived | Cuesta-Barriuso R, Merono-Gallut J, Donoso-Ubeda E, Lopez-Pina JA, Perez-Llanes R. Effect of a Fascial Therapy Treatment on Quality of Life in Patients With Hemophilic Elbow Arthropathy: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 May;103(5):867-874. doi: 10.1016/j.apmr.2021.12.023. Epub 2022 Jan 23. | |
| 33684015 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D007592 | Joint Diseases |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Screening visit, within the first seven days after treatment and after three months follow-up visit |
| Change from baseline elbow joint status after treatment and at 3 months | Change from elbow joint status during treatment and follow-up period at 3 months. Measurement instrument: Haemophilia Joint Health Score (scale 0-20). | Screening visit, within the first seven days after treatment and after three months follow-up visit |
| Change from baseline joint pain of elbow after treatment and at 3 months | Change from joint pain of ankle during treatment and follow-up period at 3 months.The perception of ankle pain will be measured using visual analog scale (scale 0-10). | Screening visit, within the first seven days after treatment and after three months follow-up visit |
| Change from baseline upper limb functionality after treatment and at 3 months | Change from upper limb functionality during treatment and follow-up period at 3 months. The perception of ankle pain will be measured using DASH Questionnaire. The Spanish version of this scale used internationally will evaluate upper limb functionality. | Screening visit, within the first seven days after treatment and after three months follow-up visit |
| Change from baseline quality of life after treatment and at 3 months | Change from quality of life during treatment and follow-up period at 3 months. The quality of life perception will be measured using SF-36 Questionnaire. This scale will assess the perception of quality of life of patients included in the study. | Screening visit, within the first seven days after treatment and after three months follow-up visit |
| Cuesta-Barriuso R, Perez-Llanes R, Lopez-Pina JA, Donoso-Ubeda E, Merono-Gallut J. Manual therapy reduces the frequency of clinical hemarthrosis and improves range of motion and perceived disability in patients with hemophilic elbow arthropathy. A randomized, single-blind, clinical trial. Disabil Rehabil. 2022 Jul;44(15):3938-3945. doi: 10.1080/09638288.2021.1894607. Epub 2021 Mar 8. |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |