Physiotherapy in the Haemophilic Arthropathy of the Elbow.

Not Applicable

Completed

• Conditions: Patients With Hemophilia
• Interventions: Other: Educational group; Other: Manual Therapy

• Registration Number: NCT02198040
• Lead Sponsor: Universidad Católica San Antonio de Murcia

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 Timeline

• Study Start: 2012-01
• Primary Completion: 2012-10
• Study Completion: 2014-06
• Study First Submitted: 2014-07-21
• Study First Submitted QC: 2014-07-22
• Study First Posted: 2014-07-23
• Results First Submitted: 2015-10-07
• Status Verified: 2016-12
• Results First Submitted QC: 2016-12-30
• Results First Posted: 2017-02-23
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational group	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.
Manual Therapy group	Manual Therapy	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

Primary Outcome Measures

Name	Time	Method
Changes in Range of Motion of Elbow	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	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 the Pain Perception of Elbow	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	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)
Changes in Biceps Strength	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).

Secondary Outcome Measures

Name	Time	Method
Characteristics of the Patients	Screening visit (pretreatment assessment)	Age of patients included in teh study (years)
Frequency of Elbow Hemarthrosis	Screening visit (pretreatment assessment)	Number of elbow hemarthrosis in the month prior to study

Trial Locations

Locations (1)

Universidad de Murcia; 🇪🇸 Murcia, Spain