In Shoulder Adhesive Capsulitis, Ultrasound-guided Anterior Hydrodilatation in Rotator Interval is More Effective Than Posterior Approach: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- visual analoge state
研究概览
简要总结
A prospective randomized controlled study among 60 consecutive adhesive capsulitis to compare between the ultrasound-guided anterior hydrodilatation in rotator interval and the posterior approach.
详细描述
patients was randomized into two equal groups. Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach; group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach.
Both groups received guided stretching exercises for 3 months after injection. Baseline and 3 months evaluation of pain by visual analogue scale (VAS), shoulder pain and disability index (SPADI), and range of motion (ROM) had been recorded for all patients.
A statistical power analysis was performed after sample size estimation, based on data from the current study (N = 60), comparing group I to group II.
Qualitative data was expressed as numbers and percentages, and Chi-squared test, Quantitative data were expressed as mean and standard deviation.
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
- Double (Participant, Outcomes Assessor)
盲法说明
the participants and outcome assessor didn't know the group classification
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 35 to 60 years,
- •patients who suffered pain and stiffness in only one shoulder, for 1 to 6 months
- •patients who had restriction of passive motion.
排除标准
- •patients with previous trauma,
- •patients with neurological
- •patients with endocrinal diseases
- •patients with shoulder tumor
- •patients with arthritis
- •people who had received intra-articular shoulder injection within the last 6 months.
- •Patients with tendon tear
研究组 & 干预措施
group 1
Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach
干预措施: ultrasound-guided posterior hydrodilatation (Procedure)
group 1
Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach
干预措施: corticosteroid, saline, and local anesthetic (Drug)
group 1
Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach
干预措施: guided stretching and strengthening exercise program (Other)
group 2
group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach
干预措施: ultrasound-guided posterior hydrodilatation (Procedure)
group 2
group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach
干预措施: guided stretching and strengthening exercise program (Other)
结局指标
主要结局
visual analoge state
时间窗: 3 months
minimum value: 0 maximum value: 10 higher scores mean a worse outcome.
shoulder pain and disability index
时间窗: 3 months
minimum value: 0 maximum value: 100 higher scores mean a worse outcome.
次要结局
未报告次要终点
研究者
Mohammed Hassan Abu-Zaid
associate professor
Tanta University