Back to resultsMyofascial Therapy in Patients With Hemophilic Arthropathy (He-Fascial)
Primary Purpose
Hemophilia
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Myofascial therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hemophilia focused on measuring Haemophilia, Arthropathy, Pain, Range of motion, Miofascial techniques
Eligibility Criteria
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.
Sites / Locations
- Universidad Católica San Antonio, MurciaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
Treatment through myofascial therapy for the treatment of pain and restricted mobility in patients with hemophilic arthropathy of the knee and ankle
No myofascial intervention. Patients continue their treatment with FVIII or FIX concentrates, normally
Outcomes
Primary Outcome Measures
Bleeding frequency
Change from number of bleeding during treatment and follow-up period at 1 month
Secondary Outcome Measures
Pain
Change from joint pain during treatment and follow-up period at 1 month
Joint function
Change from joint health during treatment and follow-up period at 1 month. Haemophilia Joint Health. Measurement instrument: Score and Gilbert score
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
Full Information
NCT ID
NCT02433782
First Posted
April 27, 2015
Last Updated
October 13, 2015
Sponsor
Universidad Católica San Antonio de Murcia
1. Study Identification
Unique Protocol Identification Number
NCT02433782
Brief Title
Myofascial Therapy in Patients With Hemophilic Arthropathy
Acronym
He-Fascial
Official Title
Physiotherapy Protocol by Myofascial Therapy and Randomized Clinical Study in Patients With Hemophilic Arthropathy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia
Keywords
Haemophilia, Arthropathy, Pain, Range of motion, Miofascial techniques
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Treatment through myofascial therapy for the treatment of pain and restricted mobility in patients with hemophilic arthropathy of the knee and ankle
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No myofascial intervention. Patients continue their treatment with FVIII or FIX concentrates, normally
Intervention Type
Other
Intervention Name(s)
Myofascial therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Bleeding frequency
Description
Change from number of bleeding during treatment and follow-up period at 1 month
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary Outcome Measure Information:
Title
Pain
Description
Change from joint pain during treatment and follow-up period at 1 month
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Title
Joint function
Description
Change from joint health during treatment and follow-up period at 1 month. Haemophilia Joint Health. Measurement instrument: Score and Gilbert score
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
Title
Range of motion
Description
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
Time Frame
Screening visit, within the first seven days after treatment and after one month follow-up visit
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RUBEN CUESTA-BARRIUSO, PhD
Phone
+34 968278545
Email
ruben.cuestab@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JAVIER MEROÑO-GALLUT, PhD
Organizational Affiliation
Universidad Católica San Antonio
Official's Role
Study Chair
Facility Information:
Facility Name
Universidad Católica San Antonio, Murcia
City
Murcia
ZIP/Postal Code
30107
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RUBEN CUESTA-BARRIUSO, PhD
Phone
+34 968278545
Email
rcuesta@ucam.edu
12. IPD Sharing Statement
Learn more about this trial
Myofascial Therapy in Patients With Hemophilic Arthropathy
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