Patients With Hemophilia
Conditions
Keywords
Elbow, Joint disease, Hemophilia, Physiotherapy modalities
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.
Interventions
OTHERManual 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). * 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
OTHEREducational 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.
Sponsors
Universidad Católica San Antonio de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Circumference of Arm | 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 the Pain Perception of Elbow | 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 | 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) |
| Changes in Range of Motion of Elbow | 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 Biceps Strength | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Elbow Hemarthrosis | Screening visit (pretreatment assessment) | Number of elbow hemarthrosis in the month prior to study |
| Characteristics of the Patients | Screening visit (pretreatment assessment) | Age of patients included in teh study (years) |
Countries
Spain
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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.
* 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 | 9 |
| 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. | 9 |
| 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. | 9 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
| Overall Study | Work reasons | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Manual Therapy Group | Educational Gruop | Control Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants | 9 Participants | 27 Participants |
| Radiological joint deterioration | 9.63 units on a scale STANDARD_DEVIATION 1.62 | 8.50 units on a scale STANDARD_DEVIATION 3.4 | 7.57 units on a scale STANDARD_DEVIATION 2.9 | 8.61 units on a scale STANDARD_DEVIATION 2.809 |
| Region of Enrollment Spain | 9 participants | 9 participants | 9 participants | 27 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 9 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 | 0 / 9 |
Outcome results
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)
Time frame: Screening visit (pretreatment assessment)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Gruop | Assessment of Radiological Joint Deterioration | 9.63 points | Standard Deviation 1.62 |
| Manual Therapy Group | Assessment of Radiological Joint Deterioration | 8.50 points | Standard Deviation 3.4 |
| Control Group | Assessment of Radiological Joint Deterioration | 7.57 points | Standard Deviation 2.9 |
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).
Time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Population: It has made an analysis by intention to treat with the 27 patients included in the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Educational Gruop | Changes in Biceps Strength | Postreatment assessment | 0.03 points | Standard Deviation 0.12 |
| Educational Gruop | Changes in Biceps Strength | Pretreatment assessment | 0.000 points | Standard Deviation 0 |
| Educational Gruop | Changes in Biceps Strength | Follow up assessment | 0.06 points | Standard Deviation 0.17 |
| Manual Therapy Group | Changes in Biceps Strength | Postreatment assessment | 0.00 points | Standard Deviation 0 |
| Manual Therapy Group | Changes in Biceps Strength | Pretreatment assessment | 0.094 points | Standard Deviation 0.272 |
| Manual Therapy Group | Changes in Biceps Strength | Follow up assessment | 0.00 points | Standard Deviation 0 |
| Control Group | Changes in Biceps Strength | Pretreatment assessment | 0.143 points | Standard Deviation 0.363 |
| Control Group | Changes in Biceps Strength | Follow up assessment | 0.07 points | Standard Deviation 0.18 |
| Control Group | Changes in Biceps Strength | Postreatment assessment | 0.07 points | Standard Deviation 0.18 |
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.
Time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Population: It has made an analysis by intention to treat with the 27 patients included in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Educational Gruop | Changes in Range of Motion of Elbow | Postreatment assessment | 135.56 degrees | Standard Deviation 16.66 |
| Educational Gruop | Changes in Range of Motion of Elbow | Pretreatment assessment | 138.31 degrees | Standard Deviation 16.103 |
| Educational Gruop | Changes in Range of Motion of Elbow | Follow up assessment | 139.19 degrees | Standard Deviation 16.64 |
| Manual Therapy Group | Changes in Range of Motion of Elbow | Postreatment assessment | 140.31 degrees | Standard Deviation 11.24 |
| Manual Therapy Group | Changes in Range of Motion of Elbow | Pretreatment assessment | 136.13 degrees | Standard Deviation 14.818 |
| Manual Therapy Group | Changes in Range of Motion of Elbow | Follow up assessment | 140.31 degrees | Standard Deviation 14.44 |
| Control Group | Changes in Range of Motion of Elbow | Pretreatment assessment | 138.00 degrees | Standard Deviation 19.958 |
| Control Group | Changes in Range of Motion of Elbow | Follow up assessment | 138.07 degrees | Standard Deviation 17.39 |
| Control Group | Changes in Range of Motion of Elbow | Postreatment assessment | 138.43 degrees | Standard Deviation 18.47 |
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.
Time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Population: It has made an analysis by intention to treat with the 27 patients included in the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Educational Gruop | Changes in the Circumference of Arm | Postreatment assessment | 31.23 cm | Standard Deviation 3.22 |
| Educational Gruop | Changes in the Circumference of Arm | Pretreatment assessment | 31.125 cm | Standard Deviation 3.144 |
| Educational Gruop | Changes in the Circumference of Arm | Follow up assessment | 31.02 cm | Standard Deviation 3.13 |
| Manual Therapy Group | Changes in the Circumference of Arm | Postreatment assessment | 31.72 cm | Standard Deviation 3.2 |
| Manual Therapy Group | Changes in the Circumference of Arm | Pretreatment assessment | 31.331 cm | Standard Deviation 3.474 |
| Manual Therapy Group | Changes in the Circumference of Arm | Follow up assessment | 30.96 cm | Standard Deviation 2.7 |
| Control Group | Changes in the Circumference of Arm | Pretreatment assessment | 32.007 cm | Standard Deviation 3.837 |
| Control Group | Changes in the Circumference of Arm | Follow up assessment | 31.68 cm | Standard Deviation 4.11 |
| Control Group | Changes in the Circumference of Arm | Postreatment assessment | 31.85 cm | Standard Deviation 3.56 |
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).
Time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Educational Gruop | Changes in the Pain Perception of Elbow | Postreatment assessment | 0.09 points | Standard Deviation 0.2 |
| Educational Gruop | Changes in the Pain Perception of Elbow | Pretreatment assessment | 0.156 points | Standard Deviation 0.301 |
| Educational Gruop | Changes in the Pain Perception of Elbow | Follow up assessment | 0.18 points | Standard Deviation 0.35 |
| Manual Therapy Group | Changes in the Pain Perception of Elbow | Postreatment assessment | 0.34 points | Standard Deviation 0.43 |
| Manual Therapy Group | Changes in the Pain Perception of Elbow | Pretreatment assessment | 0.719 points | Standard Deviation 0.752 |
| Manual Therapy Group | Changes in the Pain Perception of Elbow | Follow up assessment | 0.12 points | Standard Deviation 0.28 |
| Control Group | Changes in the Pain Perception of Elbow | Pretreatment assessment | 0.143 points | Standard Deviation 0.305 |
| Control Group | Changes in the Pain Perception of Elbow | Follow up assessment | 0.10 points | Standard Deviation 0.28 |
| Control Group | Changes in the Pain Perception of Elbow | Postreatment assessment | 0.07 points | Standard Deviation 0.67 |
Secondary
Characteristics of the Patients
Age of patients included in teh study (years)
Time frame: Screening visit (pretreatment assessment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Gruop | Characteristics of the Patients | 33.78 years | Standard Deviation 15.72 |
| Manual Therapy Group | Characteristics of the Patients | 32.33 years | Standard Deviation 11.67 |
| Control Group | Characteristics of the Patients | 37.33 years | Standard Deviation 12.26 |
Secondary
Frequency of Elbow Hemarthrosis
Number of elbow hemarthrosis in the month prior to study
Time frame: Screening visit (pretreatment assessment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Educational Gruop | Frequency of Elbow Hemarthrosis | Hemarthros the month before the beginning of the s | 1.06 bleeding events | Standard Deviation 1.23 |
| Educational Gruop | Frequency of Elbow Hemarthrosis | Hemarthros during the study | 0.00 bleeding events | Standard Deviation 0 |
| Manual Therapy Group | Frequency of Elbow Hemarthrosis | Hemarthros the month before the beginning of the s | 1.06 bleeding events | Standard Deviation 0.68 |
| Manual Therapy Group | Frequency of Elbow Hemarthrosis | Hemarthros during the study | 0.00 bleeding events | Standard Deviation 0 |
| Control Group | Frequency of Elbow Hemarthrosis | Hemarthros the month before the beginning of the s | 0.71 bleeding events | Standard Deviation 0.91 |
| Control Group | Frequency of Elbow Hemarthrosis | Hemarthros during the study | 0.62 bleeding events | Standard Deviation 0.87 |