NCT02433782

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 14, 2015

Status Verified

September 1, 2015

Enrollment Period

3 months

First QC Date

April 27, 2015

Last Update Submit

October 13, 2015

Conditions

Hemophilia

Keywords

HaemophiliaArthropathyPainRange of motionMiofascial techniques

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Pain

    Screening visit, within the first seven days after treatment and after one month follow-up visit

  • Joint function

    Screening visit, within the first seven days after treatment and after one month follow-up visit

  • Range of motion

    Screening visit, within the first seven days after treatment and after one month follow-up visit

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

NO INTERVENTION

No myofascial intervention. Patients continue their treatment with FVIII or FIX concentrates, normally

Interventions

Myofascial therapyOTHER

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

Experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica San Antonio, Murcia

Murcia, Murcia, 30107, Spain

RECRUITING

MeSH Terms

Conditions

Hemophilia AJoint DiseasesPain

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • JAVIER MEROÑO-GALLUT, PhD

    Universidad Católica San Antonio

    STUDY CHAIR

Central Study Contacts

RUBEN CUESTA-BARRIUSO, PhD

CONTACT

+34 968278545ruben.cuestab@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 27, 2015

First Posted

May 5, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 14, 2015

Record last verified: 2015-09

Locations

ES(1)