Clinical Trial: Physiotherapy in the Haemophilic Arthropathy of the Elbow.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Physiotherapy in the Treatment of Elbow Hemophilic Arthropathy: Manual Therapy vs Educational Physiotherapy. A Randomized Clinical Trial

Brief Summary: The aim of this study is to assess the effectiveness of two treatments of Physiotherapy: one with joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation (PNF), and the other with education sessions and home exercises, for the improvement of the ROM, biceps strength, perimeter of arm and the perception of pain in PwH and arthropathy of the elbow.

Detailed Summary: The intervention was carried out during twelve weeks, performing evaluations before and after treatment, and six months of finalizing this. The treatment of MT group consisted of two sessions per week, one hour each, and the treatment of group E consisted in a session for 90 minutes every two weeks, with daily home exercises. The control group (group C) did not receive any intervention.
Sponsor: Universidad Católica San Antonio de Murcia

Current Primary Outcome:

  • Changes in Range of Motion of Elbow [ Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) ]
    Measurement the changes of flexion and extension of elbow (in degrees) using a universal goniometer. We were taken as anatomical references, those specified by Querol et al, using the zero-method-reference for the mobile arm goniometer as indicated Norkin et al.
  • Changes in the Circumference of Arm [ Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) ]
    Measurement of the arm circumference (in cm) at baseline as a result of hemophilic arthropathy and after treatment and follow-up. The measurement in the upper third of the arm, in the middle of the triceps muscle belly, with a tape measure. We use this outcome to measure circumference of the arm, it is the most clinical measurement used by physiotherapists.
  • Changes in Biceps Strength [ Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) ]
    Measured by the breaking test for patients with haemophilia with a score from 0 to 5 (where 0 indicates normal strength and 5 is the absence of muscle contraction).
  • Changes in the Pain Perception of Elbow [ Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) ]
    Using the visual analogue scale, VAS (subje

    Original Primary Outcome:

    • Changes in Range of Motion of Elbow [ Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) ]
      Measurement the changes of flexion and extension of elbow (in degrees) using a universal goniometer. We were taken as anatomical references, those specified by Querol et al, using the zero-method-reference for the mobile arm goniometer as indicated Norkin et al.
    • Changes in the Circumference of Arm [ Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) ]
      Measurement of the arm circumference (in cm) at baseline as a result of hemophilic arthropathy and after treatment and follow-up. The measurement in the upper third of the arm, in the middle of the triceps muscle belly, with a tape measure. We use this outcome to measure circumference of the arm, it is the most clinical measurement used by physiotherapists.
    • Changes in Biceps Strength [ Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) ]
      Measured by the breaking test for patients with haemophilia with a score from 0 to 5 (where 0 indicates normal strength and 5 is the absence of muscle contraction).
    • Changes in the Pain Perception of Elbow [ Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) ]
      Using the visual analogue scale, VAS (subje

      Current Secondary Outcome:

      • Characteristics of the Patients [ Time Frame: Screening visit (pretreatment assessment) ]
        Age of patients included in teh study (years)
      • Frequency of Elbow Hemarthrosis [ Time Frame: Screening visit (pretreatment assessment) ]
        Number of elbow hemarthrosis in the month prior to study


      Original Secondary Outcome:

      • Characteristics of the Patients [ Time Frame: Screening visit (pretreatment assessment) ]
        Age of patient (years); Weight of patient (Kg); Elbows haemarthrosis (in the previous year); Type of haemophilia (Hemophilia A or B); Severity of the haemophilia (Severe/Moderate); Type of treatment (Prophylaxis/On demand)
      • Changes in the frequency of elbow hemarthrosis [ Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) ]
        Number of elbow hemarthrosis in the month prior to study, during it and after the follow-up period.


      Information By: Universidad Católica San Antonio de Murcia

      Dates:
      Date Received: July 21, 2014
      Date Started: January 2012
      Date Completion:
      Last Updated: December 30, 2016
      Last Verified: December 2016