Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: 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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Patients With Hemophilia Other: Manual Therapy Other: Educational group Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physiotherapy in the Treatment of Elbow Hemophilic Arthropathy: Manual Therapy vs Educational Physiotherapy. A Pilot Sudy
Study Start Date : January 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Joint Disorders

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
 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
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.
 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.
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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)


Secondary Outcome Measures :
  1. Characteristics of the Patients [ Time Frame: Screening visit (pretreatment assessment) ]
    Age of patients included in teh study (years)

  2. Frequency of Elbow Hemarthrosis [ Time Frame: Screening visit (pretreatment assessment) ]
    Number of elbow hemarthrosis in the month prior to study


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02198040


Locations
Layout table for location information
Spain
Universidad de Murcia
Murcia, Spain, 30100
Sponsors and Collaborators
Universidad Católica San Antonio de Murcia
Investigators
Layout table for investigator information
Principal Investigator: RUBEN CUESTA-BARRIUSO, PhD Universidad Católica San Antonio
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Rubén Cuesta-Barriuso, PhD, PhD, Universidad Católica San Antonio de Murcia
ClinicalTrials.gov Identifier: NCT02198040    
Other Study ID Numbers: ELBOW
ELBOW
First Posted: July 23, 2014    Key Record Dates
Results First Posted: February 23, 2017
Last Update Posted: March 1, 2018
Last Verified: December 2016
Keywords provided by Rubén Cuesta-Barriuso, PhD, Universidad Católica San Antonio de Murcia:
Elbow
Joint disease
Hemophilia
Physiotherapy modalities
Additional relevant MeSH terms:
Layout table for MeSH terms
Joint Diseases
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Musculoskeletal Diseases