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| ID | Type | Description | Link |
|---|---|---|---|
| ELBOW |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Therapy group | Experimental | 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 |
|
| Educational group | Experimental | 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. |
|
| Control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Therapy | Other |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| RUBEN CUESTA-BARRIUSO, PhD | Universidad Católica San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Murcia | Murcia | 30100 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30176883 | Derived | 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. |
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28 patients who met the exclusion criteria. Only one declined to participate for personal reasons.
27 patients Hemophilia of the Association of Murcia were recruited between January to October 2013
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| ID | Title | Description |
|---|---|---|
| FG000 | Manual Therapy Group | 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.
|
| FG001 | Educational Gruop | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Manual Therapy Group | 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.
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | It has made an analysis by intention to treat with the 27 patients included in the study. | Posted | Mean | Standard Deviation | degrees | Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Educational Gruop | 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. |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rubén Cuesta-Barriuso, PhD | Universidad de Murcia | +34 913146508 | ruben.cuestab@gmail.com |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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|
| Educational group | Other |
|
|
| Screening visit (pretreatment assessment) |
| Screening visit (pretreatment assessment) |
| BG001 | Educational Gruop | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Radiological joint deterioration | 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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 Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.
|
| OG002 | 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. |
|
|
| Primary | 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. | It has made an analysis by intention to treat with the 27 patients included in the study | Posted | Mean | Standard Deviation | cm | Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) |
|
|
|
| Primary | 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). | It has made an analysis by intention to treat with the 27 patients included in the study | Posted | Mean | Standard Deviation | points | Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | points | Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment) |
|
|
|
| Primary | 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) | 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. | Posted | Mean | Standard Deviation | points | Screening visit (pretreatment assessment) |
|
|
|
| Secondary | Characteristics of the Patients | Age of patients included in teh study (years) | Posted | Mean | Standard Deviation | years | Screening visit (pretreatment assessment) |
|
|
|
| Secondary | Frequency of Elbow Hemarthrosis | Number of elbow hemarthrosis in the month prior to study | Posted | Mean | Standard Deviation | bleeding events | Screening visit (pretreatment assessment) |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | 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 Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.
| 0 | 9 | 0 | 9 |
| EG002 | 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. | 0 | 9 | 0 | 9 |
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| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
|
| Follow up assessment |
|
|
| Follow up assessment |
|
|
| Follow up assessment |
|
|