NCT02198040|CompletedResults
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
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Sponsor study identifier
Secondary identifiers
interventional
27
1 country
1
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Actual (reported)Study Completion
June 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
October 2012
Actual (reported)June 2014
Actual (reported)July 21, 2014
Actual (reported)July 23, 2014
Actual (reported)February 23, 2017
Actual (reported)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).
Characteristics of the Patients
Screening visit (pretreatment assessment)
Frequency of Elbow Hemarthrosis
Screening visit (pretreatment assessment)
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.
* 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
Universidad de Murcia
Murcia, 30100, Spain
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.
A limitation of our study is the low sample size (n = 27), although 96% of paients who met the inclusion criteria participated Due to the randomization of subjects there was no division proportionate according to the severity of haemophilia
RUBEN CUESTA-BARRIUSO, PhD
Universidad Católica San Antonio
27 participants (actual enrollment reported by the registry).
First Submitted
July 21, 2014
First Posted
July 23, 2014
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Treatment of Tension-type Headache With Articulatory and Suboccipital Soft Tissue Therapy
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)
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.
* 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.
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Primary Completion
October 2012
Actual (reported)Study Completion
June 2014
Actual (reported)Last Updated
March 1, 2018
Results First Posted
February 23, 2017
Record last verified: 2016-12
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Source: ClinicalTrials.gov.
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