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Physiotherapy in the Haemophilic Arthropathy of the Elbow. (ELBOW)

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ClinicalTrials.gov Identifier: NCT02198040
Recruitment Status : Completed
First Posted : July 23, 2014
Results First Posted : February 23, 2017
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Rubén Cuesta-Barriuso, PhD, Universidad Católica San Antonio de Murcia

Tracking Information
First Submitted Date  ICMJE July 21, 2014
First Posted Date  ICMJE July 23, 2014
Results First Submitted Date  ICMJE October 7, 2015
Results First Posted Date  ICMJE February 23, 2017
Last Update Posted Date March 1, 2018
Study Start Date  ICMJE January 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2016)
  • 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 (subjective rating scale with a score from 0 to 10, where 0 indicates no pain and 10 the maximum pain imaginable by the patient).
  • Assessment of Radiological Joint Deterioration [ Time Frame: Screening visit (pretreatment assessment) ]
    Pettersson scale is an additive scale that assesses the radiological joint damage in patients with hemophilic arthropathy. It is scored as a range of 0-13 points (0: no joint damage; 13: maximum joint damage). This scale assesses: osteoporosis, widened epiphyseal, irregularity of the chondral surface, joint space narrowing, subchondral cyst formation, joint margins erosion, joint incongruence and joint deformity (angulation and displacement)
Original Primary Outcome Measures  ICMJE
 (submitted: July 22, 2014)
  • 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 (subjective rating scale with a score from 0 to 10, where 0 indicates no pain and 10 the maximum pain imaginable by the patient).
  • Assessment of Radiological Joint Deterioration [ Time Frame: Screening visit (pretreatment assessment) ]
    To evaluate the joint deterioration of the elbows, using a validated and objective measure, we used Pettersson scale. This scale has 13 items, where 0 indicates a normal joint and 13 a maximum joint damage.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2016)
  • 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 Measures  ICMJE
 (submitted: July 22, 2014)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physiotherapy in the Haemophilic Arthropathy of the Elbow.
Official Title  ICMJE Physiotherapy in the Treatment of Elbow Hemophilic Arthropathy: Manual Therapy vs Educational Physiotherapy. A Pilot Sudy
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 Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Patients With Hemophilia
Intervention  ICMJE
  • Other: Manual Therapy
    • 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.
    • 15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.
    • 15 minutes. Passive muscle stretching (within the limits of mobility).
    • 15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder.
    • 10 minutes. Local cryotherapy with ice bag and protection between it and the skin
  • Other: Educational group
    • Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
    • Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique.
Study Arms  ICMJE
  • Experimental: Manual Therapy group
    The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation
    Intervention: Other: Manual Therapy
  • Experimental: Educational group
    The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.
    Intervention: Other: Educational group
  • No Intervention: Control group
    The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
Publications * Cuesta-Barriuso R, Gómez-Conesa A, López-Pina JA. Manual and educational therapy in the treatment of hemophilic arthropathy of the elbow: a randomized pilot study. Orphanet J Rare Dis. 2018 Sep 3;13(1):151. doi: 10.1186/s13023-018-0884-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2014)
27
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients over 18 years
  • Patients diagnosed with hemophilia A or B
  • Patients with hemophilic arthropathy in one or both elbows

Exclusion Criteria:

  • Patients with another medical diagnosis (eg, Von Willebrand's disease)
  • Patients with presence of antibodies to FVIII or FIX (inhibitors)
  • Patients who had a haemarthrosis of elbow during the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02198040
Other Study ID Numbers  ICMJE ELBOW
ELBOW
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rubén Cuesta-Barriuso, PhD, Universidad Católica San Antonio de Murcia
Study Sponsor  ICMJE Universidad Católica San Antonio de Murcia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: RUBEN CUESTA-BARRIUSO, PhD Universidad Católica San Antonio
PRS Account Universidad Católica San Antonio de Murcia
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP