Physiotherapy in the Haemophilic Arthropathy of the Elbow.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Physiotherapy in the Treatment of Elbow Hemophilic Arthropathy: Manual Therapy vs Educational Physiotherapy. A Pilot Sudy

Conditions
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Patients With Hemophilia

Intervention / Treatment
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* Other: Manual Therapy
* Other: Educational group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual Therapy group<br>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<br>* 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<br>|
| Experimental: Educational group<br>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<br>* 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.<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Range of Motion of Elbow | 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. | Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) | 
| Changes in the Circumference of Arm | 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. | Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) | 
| Changes in Biceps Strength | 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). | Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) | 
| Changes in the Pain Perception of Elbow | 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). | Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) | 
| Assessment of Radiological Joint Deterioration | 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) | Screening visit (pretreatment assessment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of the Patients | Age of patients included in teh study (years) | Screening visit (pretreatment assessment) | 
| Frequency of Elbow Hemarthrosis | Number of elbow hemarthrosis in the month prior to study | Screening visit (pretreatment assessment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elbow, Joint disease, Hemophilia, Physiotherapy modalities