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Fascial Therapy in Elbow Hemophilic Arthropathy (HeL-Fascial)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03009591
Recruitment Status : Completed
First Posted : January 4, 2017
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Rubén Cuesta-Barriuso, PhD, Real Fundación Victoria Eugenia

Brief Summary:

Introduction: The common clinical manifestations of hemophilia are skeletal muscle bleeds, especially hematomas and hemarthrosis. Repeated episodes of joint bleeding in certain joints, causing a progressive joint deterioration. Secondary disorders to this joint degeneration include: biomechanical alterations, loss of range of movement and periarticular muscle atrophy.

Design. A prospective, multicenter and longitudinal pilot study to evaluate the efficacy of a treatment protocol with fascial therapy applied in patients with hemophilic arthropathy of the elbow.

Aimed: To evaluate the safety and efficacy of a physiotherapy treatment by fascial therapy in patients with hemophilic arthropathy of the elbow Patients: A total of 60 patients with hemophilia and prophylactic treatment will be recruited for inclusion in the study. Patients will be recruited in 6 centers, from different regions of Spain.

Intervention: Each session will last approximately 50 minutes, with three physiotherapy sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers that must be administered bilaterally:

Measuring instruments and study variables: goniometric evaluation (range of movement); visual analog scale (joint pain); Haemophilia Joint Health Score (joint status); DASH Questionnaire (functionality of upper limbs); SF-36 Questionnaire (perception of quality of life). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment.

Expected results: First, it is intended to demonstrate the safety of this physiotherapy technique in patients with hemophilia. Likewise, an improvement in the perception of elbow pain and joint mobility is expected. An improved functionality of the upper limb is also foreseen and with it, an enhanced perception of quality of life of these patients.


Condition or disease Intervention/treatment Phase
Hemophilia Other: Experimental group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective and Multicenter Study to Assess the Safety and Effectiveness of a Physiotherapy Treatment Through Fascial Therapy in Hemophilic Elbow Arthropathy. A Pilot Study.
Actual Study Start Date : February 12, 2018
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : February 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Joint Disorders

Arm Intervention/treatment
Experimental: Expermiental group
All patients included in the experimental group should be on prophylactic treatment with FVIII / FIX concentrates. Likewise, the factor should be administered on the same day that they receive each of the fascial therapy treatment sessions. Each session will last approximately 50 minutes, with three physiotherapy sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers that must be administered bilaterally:
Other: Experimental group

Longitudinal surface sliding maneuver over the superficial fascia in the anterior region of the arm and the forearm. Applied in 3 strokes.

  • Transverse sliding of the flexor muscles of the wrist and fingers.
  • Transverse sliding for the biceps brachii muscle.
  • Longitudinal surface sliding over the superficial fascia in the posterior arm region.
  • Transverse sliding over the brachial triceps tendon.
  • Transverse sliding for the pectoralis major muscle.
  • Transverse sliding for the posterior axillary region pectoralis major muscle.
  • Induction of the posterior axillary fold.
  • Induction (crossed hands over the brachial region and forearm).
  • Maneuver of transverse planes for the cervicothoracic region.
  • Upper limb telescopic maneuver.
Other Name: Fascial therapy group

No Intervention: Control group
Subjects included in the control group will not receive physical therapy through fascial therapy and will continue with their usual routine of physical activity and exercise, and with the same pharmacological treatment regimen with FVIII / FIX. At the end of the study period the intervention will be applied under the same conditions as the experimental group, analyzing the overall sample at the end of the study.



Primary Outcome Measures :
  1. Change from baseline elbow joint bleeding frequency after treatment and at 3 months [ Time Frame: Screening visit, within the first seven days after treatment and after three months follow-up visit ]
    After the first session of physiotherapy patients will be given a self-register where they can record all the observations they feel (from hematomas or hemarthros, to any other discomfort or perception). Similarly, the principal investigator of the study will monitor all patients within 48 hours after each physical therapy session.


Secondary Outcome Measures :
  1. Change from baseline range of motion of elbow after treatment and at 3 months [ Time Frame: Screening visit, within the first seven days after treatment and after three months follow-up visit ]

    Change from range of movement of elbow during treatment and follow-up period at 3 months. The range of motion of the elbow 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


  2. Change from baseline elbow joint status after treatment and at 3 months [ Time Frame: Screening visit, within the first seven days after treatment and after three months follow-up visit ]
    Change from elbow joint status during treatment and follow-up period at 3 months. Measurement instrument: Haemophilia Joint Health Score (scale 0-20).

  3. Change from baseline joint pain of elbow after treatment and at 3 months [ Time Frame: Screening visit, within the first seven days after treatment and after three months follow-up visit ]
    Change from joint pain of ankle during treatment and follow-up period at 3 months.The perception of ankle pain will be measured using visual analog scale (scale 0-10).

  4. Change from baseline upper limb functionality after treatment and at 3 months [ Time Frame: Screening visit, within the first seven days after treatment and after three months follow-up visit ]
    Change from upper limb functionality during treatment and follow-up period at 3 months. The perception of ankle pain will be measured using DASH Questionnaire. The Spanish version of this scale used internationally will evaluate upper limb functionality.

  5. Change from baseline quality of life after treatment and at 3 months [ Time Frame: Screening visit, within the first seven days after treatment and after three months follow-up visit ]
    Change from quality of life during treatment and follow-up period at 3 months. The quality of life perception will be measured using SF-36 Questionnaire. This scale will assess the perception of quality of life of patients included in the study.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with hemophilia A and B
  • Patients adults (over 18 years)
  • Patients diagnosed with hemophilic arthropathy of the elbow (by clinical assessment with the Hemophilia Joint Health Score)
  • Patients pn prophylactic treatment with FVIII / FIX concentrates.

Exclusion Criteria:

  • Patients without ambulation ability
  • Patients with inhibitors
  • Patients with neurological or cognitive alterations that impede the comprehension of the questionnaires and physical tests
  • Patients who have not signed the informed consent document.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03009591


Locations
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Spain
Royal Victoria Eugenia Foundation
Madrid, Madird, Spain, 28029
Sponsors and Collaborators
Real Fundación Victoria Eugenia

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Responsible Party: Rubén Cuesta-Barriuso, PhD, Principal Investigator, Real Fundación Victoria Eugenia
ClinicalTrials.gov Identifier: NCT03009591     History of Changes
Other Study ID Numbers: HeL-Fascial
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rubén Cuesta-Barriuso, PhD, Real Fundación Victoria Eugenia:
Hemophilia
Elbow
Arthropathy
Joint pain
Range of motion
Myofascial techniques
Safety patients
Quality of life
Functionality

Additional relevant MeSH terms:
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Hemophilia A
Joint Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Musculoskeletal Diseases