Myofascial Therapy in Patients With Hemophilic Arthropathy

Hemophilia Clinical Trial

— He-Fascial  

Official title:

Physiotherapy Protocol by Myofascial Therapy and Randomized Clinical Study in Patients With Hemophilic Arthropathy

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02433782
• Other study ID #: He-Fascial
• Status: Unknown status
• Phase: N/A
• First received: April 27, 2015
• Last updated: October 13, 2015
• Start date: September 2015
• Est. completion date: December 2015

Study information

• Verified date: September 2015
• Source: Universidad Católica San Antonio de Murcia
• Contact: RUBEN CUESTA-BARRIUSO, PhD
• Phone: +34 968278545
• Email: ruben.cuestab[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 25
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A
• Joint Diseases

Intervention

Other:
• Myofascial therapy
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

Locations

Country	Name	City	State
Spain	Universidad Católica San Antonio, Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Joint function	Change from joint health during treatment and follow-up period at 1 month. Haemophilia Joint Health. Measurement instrument: Score and Gilbert score	Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary	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