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Manual Therapy in Haemophilic Arthropathy of the Knee (ARTHROPA)

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ClinicalTrials.gov Identifier: NCT02198014
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : July 23, 2014
Sponsor:
Information provided by (Responsible Party):
RUBÉN CUESTA-BARRIUSO, Universidad Católica San Antonio de Murcia

Brief Summary:
This study aims to assess the effectiveness of two Physiotherapy treatments: one with manual therapy using joint traction, passive muscle stretching, and isometric exercise, active resisted and proprioception exercises; and other treatment with educational sessions and home exercises to improve the ROM, muscle strength and proprioception in patients with haemophilia and arthropathy of the knee.

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

Detailed Description:

Randomized trial with two treatment groups: one using joint traction, passive muscle stretching and isometric exercises, active resisted and proprioception exercises (group MT); and another with educational sessions and home exercises (group E); and a control group (group C).

The intervention was carried out during twelve weeks, performing evaluation before and after treatment, and six months of finalizing this. The treatment in MT group consisted of two sessions per week for one hour each, and the treatment in group E consisted of a session of 90 minute every two weeks, with exercises daily home. The control group (group C) did not receive any treatment. After the allocation to the groups, the composition was follows: MT group = 7; E group = 7; and control group = 7.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Manual Therapy and Educational Physiotherapy in the Treatment of Hemophilic Arthropathy of the Knee. A Randomized Pilot Study
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

Arm Intervention/treatment
Experimental: Manual Therapy group
We employed joint traction, passive muscle stretching and isometric exercises, active resisted and proprioception exercises. The treatment in this group consisted of two sessions per week for one hour each.
Other: Manual Therapy

5 minutes. Thermotherapy shallow to 50 cm away from the knee. 15 minutes. Joint traction, grade I-II. Fixation of distal femur with cinch and manual fixation of proximal tibia. Patient in prone position and the traction is carried out in the submaximal ranges of flexion and extension.

10 minutes. Passive muscle stretching of quadriceps (within the limits of mobility), through compression muscle, passive muscle stretching and relaxation of muscle.

10 minutes. Isometric and resisted exercises of quadriceps, in submaximal ranges, of flexion and extension.

10 minutes. Proprioception exercises with unipodal support, with and without visual support, and posterior destabilization.

10 minutes. Local cryotherapy with ice pack.


Experimental: Educational gruop

This group received educational sessions and home exercises. The exercises are aimed at improving quadriceps strength, flexibility, range of motion and knee proprioception.

Each educational session of 90 minute every two weeks, with exercises daily home

Other: Educational Physiotherapy
  • Theory. Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of knee; Anatomy of ankle musculature; Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
  • Practice: exercises in favor of gravity; active exercises for mobility and pain management; knee proprioception exercises; isometric and isotonic exercises of quadriceps; swimming and cycling technique.

No Intervention: Control group
The control group (group C) did not receive any treatment. The patients of this group were assessed by the same reviewers and under the same conditions as the subjects of the two intervention groups.



Primary Outcome Measures :
  1. Changes in the range of movement (ROM) [ Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) ]
    Measurement of knee flexion and extension using a universal goniometer. Were taken as anatomical references, are indicated by Querol et al, using the reference method 0 to the mobile arm of the goniometer, as noted Norkin et al.

  2. Changes in quadriceps muscle circumference [ Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) ]
    Measurement in the thigh, in two thirds of the flow distance between the anterior superior iliac spine and the joint line of the knee, using a tape measure

  3. Changes in muscle strength of quadriceps [ Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) ]
    Measured by the rupture test for hemophilia patients (with a gradation of 0 to 5 points, with 0 indicating normal strength and 5 is the absence of muscle contraction).

  4. Changes in the perception of pain [ Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) ]
    Using the visual analog scale, VAS, consisting of a gradation of 0 to 10 points (from no pain to worst pain imaginable).

  5. Changes in the assessment of radiological joint deterioration [ Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) ]
    We use the Petterson scale which consists of 13 items (0 indicates a normal joint and joint deterioration 13 maximum).


Secondary Outcome Measures :
  1. Subjects' physical characteristics [ Time Frame: Screening visit (pretreatment assessment) ]
    Age of patient (years), Weight of patient (kg), Number of ankle haemarthrosis in previous year, Type of haemophilia (A or B), Severity of haemophilia (severe or moderate), Treatment (prophylaxis or on demand).

  2. Changes in the frequency of knee hemarthrosis [ Time Frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) ]
    Evaluation of knee bleeding before, during and after physiotherapy treatment. Hemarthrosis must be diagnosed clinically.



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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 must be over the age of 18 years
  • Diagnosis of haemophilia A or B
  • Patients with haemophilic arthropathy in one or both knees

Exclusion Criteria:

  • Patients who had a haemarthrosis of knee during intervention
  • Patients with different medical diagnosis (eg, Von Willebrand's disease)
  • Patients with antibodies to FVIII or FIX (inhibitors).

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): NCT02198014


Locations
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Spain
Universidad de Murcia
Murcia, Spain, 30100
Sponsors and Collaborators
Universidad Católica San Antonio de Murcia
Investigators
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Principal Investigator: RUBEN CUESTA-BARRIUSO, PhD Universidad Católica San Antonio

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: RUBÉN CUESTA-BARRIUSO, PhD, Universidad Católica San Antonio de Murcia
ClinicalTrials.gov Identifier: NCT02198014     History of Changes
Other Study ID Numbers: ARTHROPATHY
ARTHROPAT
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: June 2014
Keywords provided by RUBÉN CUESTA-BARRIUSO, Universidad Católica San Antonio de Murcia:
Knee
Joint disease
Haemophilia
Physiotherapy modalities
Additional relevant MeSH terms:
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Joint Diseases
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Musculoskeletal Diseases