Physiotherapy in the Treatment of Elbow Hemophilic Arthropathy: Manual Therapy vs Educational Physiotherapy. A Pilot Sudy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Changes in Range of Motion of Elbow
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years
- •Patients diagnosed with hemophilia A or B
- •Patients with hemophilic arthropathy in one or both elbows
排除标准
- •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
研究组 & 干预措施
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
干预措施: Manual Therapy (Other)
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.
干预措施: Educational group (Other)
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.
结局指标
主要结局
Changes in Range of Motion of Elbow
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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 Biceps Strength
时间窗: 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).
次要结局
- Characteristics of the Patients(Screening visit (pretreatment assessment))
- Frequency of Elbow Hemarthrosis(Screening visit (pretreatment assessment))
研究者
Rubén Cuesta-Barriuso, PhD
PhD
Universidad Católica San Antonio de Murcia