Effectiveness of the Myofascial Therapy in the Hemophilic Arthropathy of Ankle

Randomized Clinical Study on the Effectiveness of the Myofascial Therapy in the Treatment of the Hemophilic Arthropathy of Ankle

Randomized clinical trial to assess the efficacy of a treatment protocol applied fascial therapy in patients with hemophilic arthropathy ankle, oriented to know and describe the observed differences on the dependent variables: range of motion, pain and physical condition.

At the same time, the study will determine whether there are adverse effects or bleeding complications as a result of applied physiotherapy treatment.

Study Overview

• Status: Completed
• Conditions: Haemophilia
• Intervention / Treatment: Other: Physiotherapy sessions

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Patients diagnosed with hemophilia A and B
• Adults patients
• Patients with hemophilic arthropathy of ankle diagnosed
• Patients in prophylactic treatment regimen or on demand treatment with concentrates of FVIII/FIX.

Exclusion Criteria:

• Patients without ambulation
• Patients diagnosed with other congenital coagulopathy (eg, Von Willebrand disease)
• Patients who have developed antibodies to FVIII / FIX (inhibitors)
• Patients with neurological or cognitive impairments that prevent understanding of questionnaires and test physical
• Patients that have not signed the informed consent document.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group; Patients included in this group will receive treatment over a period of three weeks, receiving 3 physiotherapy sessions lasting approximately 30 minutes each. The treatment program includes 8 maneuvers that must be administered bilaterally: maneuver longitudinal sliding on the fascial surface plant, maneuver induction of the plantar fascia, maneuver longitudinal surface sliding on the anterolateral compartment of the leg, induction maneuver ankle anterior compartment, maneuver pressure and sliding on the posterior region of the leg, technical release of the popliteal fascia, maneuver induction sural triceps, and lower extremity telescopic technique.	Other: Physiotherapy sessions; Physiotherapy by techniques myofascial therapy, in patients with ankle hemophilic arthropathy
NO_INTERVENTION: Control group; Patients included in this group will not receive any physiotherapy treatment. However, will be evaluated under the same conditions that patients in the experimental group (pretreatment evaluation, post-treatment and follow-up).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline bleeding frequency after treatment and at 5 months	Evaluation of the frequency of muscle and joint bleeds through registration. The frequency of bleeding of the ankle joint is measured with a registry given to patients at the beginning of the study.	Screening visit, within the first seven days after treatment and after five months follow-up visit
Change from baseline joint pain of ankle after treatment and at 5 months	Change from joint pain of ankle during treatment and follow-up period at 5 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 five months follow-up visit
Change from baseline joint function after treatment and at 5 months	Change from joint health during treatment and follow-up period at 5 months. Measurement instrument: Haemophilia Joint Health Score (scale 0-20).	Screening visit, within the first seven days after treatment and after five months follow-up visit
Change from baseline range of motion after treatment and at 5 months	Change from range of movement of ankle and knee during treatment and follow-up period at 5 months. The range of motion of the ankle 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	Screening visit, within the first seven days after treatment and after five months follow-up visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Height of patients	Screening visit
Age	Age of patients	Screening visit
Weight	Weight of patients included in the study	Screening visit

Collaborators and Investigators

• Sponsor: Real Fundación Victoria Eugenia

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 12, 2016
• Primary Completion (ACTUAL): September 8, 2017
• Study Completion (ACTUAL): September 26, 2017

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: July 4, 2016
• First Posted (ESTIMATE): July 7, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2017
• Last Update Submitted That Met QC Criteria: September 26, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Pain; Haemophilia; Arthropathy; Range of motion; Myofascial techniques; Ankle
• 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: AnHe-Fascial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO