Effectiveness of Manual Therapy and Educational Physiotherapy in the Treatment of Hemophilic Arthropathy of the Knee. A Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Changes in the range of movement (ROM)
研究概览
简要总结
This study aims to assess the effectiveness of two Physiotherapy treatments: one with manual therapy using joint traction, passive muscle stretching, and isometric exercise, active resisted and proprioception exercises; and other treatment with educational sessions and home exercises to improve the ROM, muscle strength and proprioception in patients with haemophilia and arthropathy of the knee.
详细描述
Randomized trial with two treatment groups: one using joint traction, passive muscle stretching and isometric exercises, active resisted and proprioception exercises (group MT); and another with educational sessions and home exercises (group E); and a control group (group C).
The intervention was carried out during twelve weeks, performing evaluation before and after treatment, and six months of finalizing this. The treatment in MT group consisted of two sessions per week for one hour each, and the treatment in group E consisted of a session of 90 minute every two weeks, with exercises daily home. The control group (group C) did not receive any treatment. After the allocation to the groups, the composition was follows: MT group = 7; E group = 7; and control group = 7.
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 must be over the age of 18 years
- •Diagnosis of haemophilia A or B
- •Patients with haemophilic arthropathy in one or both knees
排除标准
- •Patients who had a haemarthrosis of knee during intervention
- •Patients with different medical diagnosis (eg, Von Willebrand's disease)
- •Patients with antibodies to FVIII or FIX (inhibitors).
研究组 & 干预措施
Educational gruop
This group received educational sessions and home exercises. The exercises are aimed at improving quadriceps strength, flexibility, range of motion and knee proprioception.
Each educational session of 90 minute every two weeks, with exercises daily home
干预措施: Educational Physiotherapy (Other)
Control group
The control group (group C) did not receive any treatment. The patients of this group were assessed by the same reviewers and under the same conditions as the subjects of the two intervention groups.
Manual Therapy group
We employed joint traction, passive muscle stretching and isometric exercises, active resisted and proprioception exercises. The treatment in this group consisted of two sessions per week for one hour each.
干预措施: Manual Therapy (Other)
结局指标
主要结局
Changes in the range of movement (ROM)
时间窗: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Measurement of knee flexion and extension using a universal goniometer. Were taken as anatomical references, are indicated by Querol et al, using the reference method 0 to the mobile arm of the goniometer, as noted Norkin et al.
Changes in muscle strength of quadriceps
时间窗: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Measured by the rupture test for hemophilia patients (with a gradation of 0 to 5 points, with 0 indicating normal strength and 5 is the absence of muscle contraction).
Changes in quadriceps muscle circumference
时间窗: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Measurement in the thigh, in two thirds of the flow distance between the anterior superior iliac spine and the joint line of the knee, using a tape measure
Changes in the perception of pain
时间窗: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Using the visual analog scale, VAS, consisting of a gradation of 0 to 10 points (from no pain to worst pain imaginable).
Changes in the assessment of radiological joint deterioration
时间窗: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
We use the Petterson scale which consists of 13 items (0 indicates a normal joint and joint deterioration 13 maximum).
次要结局
- Subjects' physical characteristics(Screening visit (pretreatment assessment))
- Changes in the frequency of knee hemarthrosis(Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment))
研究者
RUBÉN CUESTA-BARRIUSO
PhD
Universidad Católica San Antonio de Murcia