Physiotherapy in the Haemophilic Arthropathy of the Elbow.

Patients With Hemophilia Clinical Trial

— ELBOW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198040
• Other study ID #: ELBOW
• Secondary ID: ELBOW
• Status: Completed
• Phase: N/A
• First received: July 21, 2014
• Last updated: January 31, 2018
• Start date: January 2012
• Est. completion date: June 2014

Study information

• Verified date: December 2016
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2014
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia A
• Joint Diseases
• Patients With Hemophilia

Intervention

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
• 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.

Locations

Country	Name	City	State
Spain	Universidad de Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Characteristics of the Patients	Age of patients included in teh study (years)	Screening visit (pretreatment assessment)
Secondary	Frequency of Elbow Hemarthrosis	Number of elbow hemarthrosis in the month prior to study	Screening visit (pretreatment assessment)