Physiotherapy in the Haemophilic Arthropathy of the Elbow. (ELBOW)
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|ClinicalTrials.gov Identifier: NCT02198040|
Recruitment Status : Completed
First Posted : July 23, 2014
Results First Posted : February 23, 2017
Last Update Posted : March 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Patients With Hemophilia||Other: Manual Therapy Other: Educational group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Physiotherapy in the Treatment of Elbow Hemophilic Arthropathy: Manual Therapy vs Educational Physiotherapy. A Pilot Sudy|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||June 2014|
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
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
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.
- Changes in Range of Motion of Elbow [ Time Frame: 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 [ Time Frame: 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 Biceps Strength [ Time Frame: 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).
- Changes in the Pain Perception of Elbow [ Time Frame: 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 [ Time Frame: 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)
- Characteristics of the Patients [ Time Frame: Screening visit (pretreatment assessment) ]Age of patients included in teh study (years)
- Frequency of Elbow Hemarthrosis [ Time Frame: Screening visit (pretreatment assessment) ]Number of elbow hemarthrosis in the month prior to study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198040
|Universidad de Murcia|
|Murcia, Spain, 30100|
|Principal Investigator:||RUBEN CUESTA-BARRIUSO, PhD||Universidad Católica San Antonio|