Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02198040
Recruitment Status : Completed
First Posted : July 23, 2014
Results First Posted : February 23, 2017
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Rubén Cuesta-Barriuso, PhD, Universidad Católica San Antonio de Murcia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Patients With Hemophilia
Interventions Other: Manual Therapy
Other: Educational group
Enrollment 27
Recruitment Details 27 patients Hemophilia of the Association of Murcia were recruited between January to October 2013
Pre-assignment Details 28 patients who met the exclusion criteria. Only one declined to participate for personal reasons.
Arm/Group Title Manual Therapy Group Educational Gruop Control Group
Hide Arm/Group Description

The treatment of this group consisted of two sessions per week, one hour each. 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). Compression technique, passive muscle stretching and relaxation in biceps and triceps.
  • 15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder with extension of elbow and dorsal flexion of wrist, to adduction, internal rotation of shoulder with flexion of elbow and palmar flexion of wrist and fingers.
  • 10

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.

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.

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.
Period Title: Overall Study
Started 9 9 9
Completed 9 8 8
Not Completed 0 1 1
Reason Not Completed
Work reasons             0             1             0
Withdrawal by Subject             0             0             1
Arm/Group Title Manual Therapy Group Educational Gruop Control Group Total
Hide Arm/Group Description

The treatment of this group consisted of two sessions per week, one hour each.

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). Compression technique, passive muscle stretching and relaxation in biceps and triceps.
  • 15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder with extension of elbow and dorsal flexion of wrist, to adduction, internal rotation of shoulder with flexion of elbow and palmar flexion of wrist and fingers.
  • 10 minutes. Local cryotherapy with ice bag and protection between it and the skin

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.

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.

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. Total of all reporting groups
Overall Number of Baseline Participants 9 9 9 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 9 participants 27 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
 100.0%
9
 100.0%
9
 100.0%
27
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 9 participants 27 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
9
 100.0%
9
 100.0%
9
 100.0%
27
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 9 participants 9 participants 9 participants 27 participants
9 9 9 27
Radiological joint deterioration   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 9 participants 9 participants 9 participants 27 participants
9.63  (1.62) 8.50  (3.40) 7.57  (2.90) 8.61  (2.809)
[1]
Measure Description: Radiological joint deterioration of elbows with Pettersson score. Mean score (and standard deviation) for elbow joint evaluated in patients enrolled in the study. This scale has a range from 0 to 13 points (0 indicates no joint damage and 13 indicates maximum joint damage) to assess the hemophilic arthropathy.
1.Primary Outcome
Title Changes in Range of Motion of Elbow
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
It has made an analysis by intention to treat with the 27 patients included in the study.
Arm/Group Title Educational Gruop Manual Therapy Group Control Group
Hide Arm/Group 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.

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.

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

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). Compression technique, passive muscle stretching and relaxation in biceps and triceps.
  • 15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.
  • 10 minutes. Local cryotherapy with ice bag and protection between it and the skin
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.
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: degrees
Pretreatment assessment 138.31  (16.103) 136.13  (14.818) 138.00  (19.958)
Postreatment assessment 135.56  (16.66) 140.31  (11.24) 138.43  (18.47)
Follow up assessment 139.19  (16.64) 140.31  (14.44) 138.07  (17.39)
2.Primary Outcome
Title Changes in the Circumference of Arm
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
It has made an analysis by intention to treat with the 27 patients included in the study
Arm/Group Title Educational Gruop Manual Therapy Group Control Group
Hide Arm/Group 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.

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.

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

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). Compression technique, passive muscle stretching and relaxation in biceps and triceps.
  • 15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.
  • 10 minutes. Local cryotherapy with ice bag and protection between it and the skin
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.
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: cm
Pretreatment assessment 31.125  (3.144) 31.331  (3.474) 32.007  (3.837)
Postreatment assessment 31.23  (3.22) 31.72  (3.20) 31.85  (3.56)
Follow up assessment 31.02  (3.13) 30.96  (2.70) 31.68  (4.11)
3.Primary Outcome
Title Changes in Biceps Strength
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
It has made an analysis by intention to treat with the 27 patients included in the study
Arm/Group Title Educational Gruop Manual Therapy Group Control Group
Hide Arm/Group 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.

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.

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

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). Compression technique, passive muscle stretching and relaxation in biceps and triceps.
  • 15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.
  • 10 minutes. Local cryotherapy with ice bag and protection between it and the skin
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.
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: points
Pretreatment assessment 0.000  (0.000) 0.094  (0.272) 0.143  (0.363)
Postreatment assessment 0.03  (0.12) 0.00  (0.00) 0.07  (0.18)
Follow up assessment 0.06  (0.17) 0.00  (0.00) 0.07  (0.18)
4.Primary Outcome
Title Changes in the Pain Perception of Elbow
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Educational Gruop Manual Therapy Group Control Group
Hide Arm/Group 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.

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.

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

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). Compression technique, passive muscle stretching and relaxation in biceps and triceps.
  • 15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.
  • 10 minutes. Local cryotherapy with ice bag and protection between it and the skin
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.
Overall Number of Participants Analyzed 8 8 7
Mean (Standard Deviation)
Unit of Measure: points
Pretreatment assessment 0.156  (0.301) 0.719  (0.752) 0.143  (0.305)
Postreatment assessment 0.09  (0.20) 0.34  (0.43) 0.07  (0.67)
Follow up assessment 0.18  (0.35) 0.12  (0.28) 0.10  (0.28)
5.Primary Outcome
Title Assessment of Radiological Joint Deterioration
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
It has made an analysis by intention to treat with the 27 patients included in the study. It has been estimated the radiological joint damage means (and standard deviation) for elbow joint.
Arm/Group Title Manual Therapy Group Educational Gruop Control Group
Hide Arm/Group 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

Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.

  • 15 minutes. Joint traction of elbow. Joint traction in I-II degree of flexion and extension submaximal of elbow.
  • 15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.
  • 15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder with extension of elbow and dorsal flexion of wrist.
  • 10

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.

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.

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.
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: points
9.63  (1.62) 8.50  (3.40) 7.57  (2.90)
6.Secondary Outcome
Title Characteristics of the Patients
Hide Description Age of patients included in teh study (years)
Time Frame Screening visit (pretreatment assessment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Educational Gruop Manual Therapy Group Control Group
Hide Arm/Group 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.

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.

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

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). Compression technique, passive muscle stretching and relaxation in biceps and triceps.
  • 15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.
  • 10 minutes. Local cryotherapy with ice bag and protection between it and the skin
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.
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: years
33.78  (15.72) 32.33  (11.67) 37.33  (12.26)
7.Secondary Outcome
Title Frequency of Elbow Hemarthrosis
Hide Description Number of elbow hemarthrosis in the month prior to study
Time Frame Screening visit (pretreatment assessment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Educational Gruop Manual Therapy Group Control Group
Hide Arm/Group 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.

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.

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

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). Compression technique, passive muscle stretching and relaxation in biceps and triceps.
  • 15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.
  • 10 minutes. Local cryotherapy with ice bag and protection between it and the skin
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.
Overall Number of Participants Analyzed 9 9 9
Mean (Standard Deviation)
Unit of Measure: bleeding events
Hemarthros the month before the beginning of the s 1.06  (1.23) 1.06  (0.68) 0.71  (0.91)
Hemarthros during the study 0.00  (0.00) 0.00  (0.00) 0.62  (0.87)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Educational Gruop Manual Therapy Group Control Group
Hide Arm/Group 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.

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.

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

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). Compression technique, passive muscle stretching and relaxation in biceps and triceps.
  • 15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.
  • 10 minutes. Local cryotherapy with ice bag and protection between it and the skin
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.
All-Cause Mortality
Educational Gruop Manual Therapy Group Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Educational Gruop Manual Therapy Group Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%)   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Educational Gruop Manual Therapy Group Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%)   0/9 (0.00%) 
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
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rubén Cuesta-Barriuso, PhD
Organization: Universidad de Murcia
Phone: +34 913146508
EMail: ruben.cuestab@gmail.com
Layout table for additonal information
Responsible Party: Rubén Cuesta-Barriuso, PhD, Universidad Católica San Antonio de Murcia
ClinicalTrials.gov Identifier: NCT02198040    
Other Study ID Numbers: ELBOW
ELBOW
First Submitted: July 21, 2014
First Posted: July 23, 2014
Results First Submitted: October 7, 2015
Results First Posted: February 23, 2017
Last Update Posted: March 1, 2018