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

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

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.

Study Overview

• Status: Completed
• Conditions: Patients With Hemophilia
• Intervention / Treatment: Other: Manual Therapy; Other: Educational group

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30100
    • Universidad de Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Publications and helpful links

General Publications

• Cuesta-Barriuso R, Gomez-Conesa A, Lopez-Pina JA. Manual and educational therapy in the treatment of hemophilic arthropathy of the elbow: a randomized pilot study. Orphanet J Rare Dis. 2018 Sep 3;13(1):151. doi: 10.1186/s13023-018-0884-5.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: July 21, 2014
• First Submitted That Met QC Criteria: July 22, 2014
• First Posted (Estimate): July 23, 2014

Study Record Updates

• Last Update Posted (Actual): March 1, 2018
• Last Update Submitted That Met QC Criteria: January 31, 2018
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Hemophilia; Elbow; Joint disease; Physiotherapy modalities
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Musculoskeletal Diseases; Blood Coagulation Disorders; Hemophilia A; Joint Diseases
• Other Study ID Numbers: ELBOW