Myofascial Therapy in Patients With Hemophilic Arthropathy (He-Fascial)

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.

Study Overview

• Status: Unknown
• Conditions: Hemophilia
• Intervention / Treatment: Other: Myofascial therapy

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 Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Recruiting
    • Universidad Católica San Antonio, Murcia
    • Contact: RUBEN CUESTA-BARRIUSO, PhD; Phone Number: +34 968278545; Email: rcuesta@ucam.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Treatment through myofascial therapy for the treatment of pain and restricted mobility in patients with hemophilic arthropathy of the knee and ankle	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
No Intervention: Control group; No myofascial intervention. Patients continue their treatment with FVIII or FIX concentrates, normally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia
• Investigators: Study Chair: JAVIER MEROÑO-GALLUT, PhD, Universidad Católica San Antonio

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: April 27, 2015
• First Submitted That Met QC Criteria: April 29, 2015
• First Posted (Estimate): May 5, 2015

Study Record Updates

• Last Update Posted (Estimate): October 14, 2015
• Last Update Submitted That Met QC Criteria: October 13, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Pain; Haemophilia; Arthropathy; Range of motion; Miofascial techniques
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Musculoskeletal Diseases; Blood Coagulation Disorders; Hemophilia A; Joint Diseases
• Other Study ID Numbers: He-Fascial