Myofascial Therapy in Patients With Hemophilic Arthropathy

Not Applicable

• Conditions: Hemophilia
• Interventions: Other: Myofascial therapy

• Registration Number: NCT02433782
• Lead Sponsor: Universidad Católica San Antonio de Murcia

Brief 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.

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 Timeline

• Study First Submitted: 2015-04-27
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-05-05
• Status Verified: 2015-09
• Study Start: 2015-09
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-14
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Myofascial therapy	Treatment through myofascial therapy for the treatment of pain and restricted mobility in patients with hemophilic arthropathy of the knee and ankle

Primary Outcome Measures

Name	Time	Method
Bleeding frequency	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

Secondary Outcome Measures

Name	Time	Method
Joint function	Screening visit, within the first seven days after treatment and after one month follow-up visit	Change from joint health during treatment and follow-up period at 1 month. Haemophilia Joint Health. Measurement instrument: Score and Gilbert score
Pain	Screening visit, within the first seven days after treatment and after one month follow-up visit	Change from joint pain during treatment and follow-up period at 1 month
Range of motion	Screening visit, within the first seven days after treatment and after one month follow-up visit	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

Trial Locations

Locations (1)

Universidad Católica San Antonio, Murcia; 🇪🇸 Murcia, Spain