search
Back to results

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

Primary Purpose

Patients With Hemophilia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual Therapy
Educational group
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Hemophilia focused on measuring Elbow, Joint disease, Hemophilia, Physiotherapy modalities

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad de Murcia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Manual Therapy group

Educational group

Control group

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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).
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).
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)

Secondary Outcome Measures

Characteristics of the Patients
Age of patients included in teh study (years)
Frequency of Elbow Hemarthrosis
Number of elbow hemarthrosis in the month prior to study

Full Information

First Posted
July 21, 2014
Last Updated
January 31, 2018
Sponsor
Universidad Católica San Antonio de Murcia
search

1. Study Identification

Unique Protocol Identification Number
NCT02198040
Brief Title
Physiotherapy in the Haemophilic Arthropathy of the Elbow.
Acronym
ELBOW
Official Title
Physiotherapy in the Treatment of Elbow Hemophilic Arthropathy: Manual Therapy vs Educational Physiotherapy. A Pilot Sudy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Hemophilia
Keywords
Elbow, Joint disease, Hemophilia, Physiotherapy modalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Therapy group
Arm Type
Experimental
Arm Description
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
Arm Title
Educational group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Educational group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Range of Motion of Elbow
Description
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.
Time Frame
Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Title
Changes in the Circumference of Arm
Description
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.
Time Frame
Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Title
Changes in Biceps Strength
Description
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).
Time Frame
Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Title
Changes in the Pain Perception of Elbow
Description
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).
Time Frame
Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Title
Assessment of Radiological Joint Deterioration
Description
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)
Time Frame
Screening visit (pretreatment assessment)
Secondary Outcome Measure Information:
Title
Characteristics of the Patients
Description
Age of patients included in teh study (years)
Time Frame
Screening visit (pretreatment assessment)
Title
Frequency of Elbow Hemarthrosis
Description
Number of elbow hemarthrosis in the month prior to study
Time Frame
Screening visit (pretreatment assessment)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RUBEN CUESTA-BARRIUSO, PhD
Organizational Affiliation
Universidad Católica San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Murcia
City
Murcia
ZIP/Postal Code
30100
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
30176883
Citation
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.
Results Reference
derived

Learn more about this trial

Physiotherapy in the Haemophilic Arthropathy of the Elbow.

We'll reach out to this number within 24 hrs