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临床试验/NCT04654169
NCT04654169已完成不适用

Effectiveness of Suprascapular Nerve Block in Addition to Intra-articular Corticosteroid Injection in Adhesive Capsulitis: A Double-blind, Randomized Controlled Trial

Marmara University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
Shoulder Pain and Disability Index (SPADI)

研究概览

简要总结

Adhesive capsulitis is a disease that negatively affects a person's quality of life by causing severe pain and limitation in the movements of the shoulder joint in all directions. Conservative approaches including nonsteroidal anti-inflammatory drugs or oral corticosteroid usage and physiotherapy program are the first choice for the treatment. However, painful exercises usually prevent patients from fully participating in the physiotherapy program. For this reason, interventional procedures such as intra-articular corticosteroid injection (IAI) and suprascapular nerve block (SSNB) are preferred to be applied before the physiotherapy program.

The aim of this study is to reveal both short and long-term effects of SSNB and IAI combination on pain, shoulder range of motion (ROM), disability, and quality of life in patients with adhesive capsulitis. It is hypothesized that the addition of SSNB to IAI results in greater improvements in pain, passive and active shoulder ROMs, disability, and quality of life.

详细描述

Adhesive capsulitis (AK), also known as frozen shoulder, is a disease that negatively affects a person's quality of life by causing severe pain and limitation in the movements of the shoulder joint in all directions. Although the underlying etiology is not clear, it may develop as a result of primary (idiopathic) or secondary causes such as diabetes mellitus, malignancy, thyroid dysfunction, hypoadrenalism, Parkinson's disease, stroke, cardiac and pulmonary diseases, or local shoulder problems such as trauma, tendinitis, rupture. Prolonged immobilization after injuries is another important risk factor for adhesive capsulitis. It is more common in women between the ages of 40-60. Conservative approaches including nonsteroidal anti-inflammatory drugs or oral corticosteroid usage and physiotherapy program are the first choice for the treatment. The physiotherapy program consisting range of motion (ROM), stretching and strengthening exercises are often painful and prevent the patient's full participation. For this reason, interventional procedures such as intra-articular corticosteroid injection (IAI) and suprascapular nerve block (SSNB) are preferred to be applied before the physiotherapy program.

The aim of this study is to reveal both short and long-term effects of SSNB and IAI combination on pain, shoulder ROM, disability, and quality of life in patients with adhesive capsulitis. It is hypothesized that the addition of SSNB to IAI results in greater improvements in pain, passive and active shoulder ROMs, disability, and quality of life. The primary outcome measure of the study is determined to be the Shoulder Pain and Disability Index (SPADI), while the secondary outcome measures to be the Numeric Rating Scale (NRS), active and passive ROMs, and the Short Form 36 (SF-36).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Allocation information of patients was only given to the physiatrists who would apply the intervention. Another physiatrist who completed the pre and post-treatment assessments and the patients were blinded to the allocation.

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Shoulder Pain and Disability Index (SPADI)

时间窗: Twelve months after the intervention (T4)

The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire consisting of 13 items divided into two subscales varying between 0 to 100, with a higher value indicating worse condition.

次要结局

  • Numeric Rating Scale (NRS)(Twelve months after the intervention (T4))
  • Short Form-36(Twelve months after the intervention (T4))
  • Shoulder range of motion (ROM) evaluated with a handheld goniometer(Twelve months after the intervention (T4))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kardelen Gencer Atalay

Principal Investigator

Marmara University

研究点 (2)

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