Comparison between ultrasound guided Suprascapular nerve block and the combination of Suprascapular nerve block with Intra-articular steroids via anterior Rotator cuff approach for Adhesive capsulitis, in Diabetes mellitus patients.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To evaluate shoulder pain measured by a visual Numeric Pain Rating Scale (NPRS).
研究概览
简要总结
INTRODUCTION:
Frozen shoulder is one of the most common musculoskeletal problems seen in diabetes mellitus patients.
Many treatment modalities are available. US guided suprascapular nerve block and Intra-articular steroid injection via Rotator cuff approach is a very common treatment modality.
The data on comparative efficacy is however limited.
The present study will be done to compare the efficacy of US guided suprascapular nerve block and Intra-articular steroids in the management of painful frozen shoulder.
PRIMARY OBJECTIVE: To evaluate shoulder pain measured by Numeric Pain Rating Scale(NPRS).
SECONDARY OBJECTIVE:
To measure the functional disability evaluated by the SPADI and DASH score.
To evaluate passive ROM measured by a goniometer.
Decreased requirement for additional therapies for Frozen shoulder
TYPE OF STUDY: Randomised, prospective,single blinded study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult patients (18-70 years), diagnosed with controlled type 2 Diabetes Mellitus and clinically diagnosed with Frozen shoulder, with a symptom duration of minimum 3 Months, with no radiographic findings on shoulder radiographs except for osteoporosis.
- •Informed written consent
- •Either sex
- •Diagnosed as Frozen shoulder; clinically: pain and restriction in ROM (≥ 25% loss of ROM in≥ 2 directions, i.e. abduction, flexion, extension, external rotation, and internal rotation).
排除标准
- •Patient refusal
- •Other causes of Frozen Shoulder, such as the Concomitant rotator cuff tear, calcific tendinitis, rheumatic diseases and infection
- •Osteoarthritis,
- •History of high-energy trauma,
- •Previous shoulder surgery,
- •Previous Corticosteroid injection on the affected side within 3 months before the visit of our clinic,
- •Incomplete data before the injection and at 3, 6, 9 and 12 Weeks after the injection,
- •Poor cognitive Function
- •Bleeding diathesis 10.Infection at the site of injection 11.Inability to consent.
结局指标
主要结局
To evaluate shoulder pain measured by a visual Numeric Pain Rating Scale (NPRS).
时间窗: Baseline(before treatment), | after treatment, 3rd week, 6th week, 9th week, 12th week.
次要结局
- 1. To measure the functional disability evaluated by SPADI and DASH score.(2. Decreased requirement for additional therapies for frozen shoulder)
研究者
Dr Jessica Khajuria
Government Medical College, Jammu