跳至主要内容
临床试验/NCT05909462
NCT05909462已完成不适用

Comparison of the Effects of Ultrasonography-guided Suprascapular Nerve Block and Intra-articular Shoulder Injection on Pain, Functional Status and Range of Motion in Patients With Adhesive Capsulitis; Randomized, Controlled Trial

Hitit University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2023年1月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Changes from baseline in pain on The Shoulder Pain and Disability Index (SPADI) at the tenth day after the injection

研究概览

简要总结

Objectives: In this study, we aimed to compare the efficacy of ultrasonography-guided suprascapular nerve block and intra-articular shoulder injection treatment in terms of joint range of motion, pain and functional status in patients with adhesive capsulitis (AC).

Patients and Methods: 60 patients AC were included in our study. The patients were randomized into two groups according to the sealed envelope method. In the evaluation of the patients before the injection, age, gender, body mass index (BMI), occupation, education, duration of complaint, symptomatic side and dominant hand information were recorded. In the first group, 2 ml of 40 mg triamcinolone acetonide and 4 ml of 1% lidocaine injection were mixed with the posterior approach method into the shoulder joint under the guidance of ultrasonography (USG). The second group underwent suprascapular nerve block (SSNB) injection with 2 ml of 40 mg triamcinolone acetonide and 4 ml of 1% lidocaine under USG guidance. Shoulder range of motion (ROM), visual analog scale (VAS) scores and Shoulder Pain and Disability Index (SPADI) scores were compared before the injection, on the tenth day after the injection and at the third month after the injection.

Conclusion: As a result of our study, although it was observed that both methods provided improvement in the treatment process, the significant improvement in the SSNB group indicates that it is a more reliable treatment method in AC treatment.

详细描述

Sixty patients AC who applied to our Orthopedics-Traumatology and Physical Medicine-Rehabilitation Outpatient Clinic were included in our study. The study was approved by the Hitit University Clinical Research Ethics Committee (Decision number:2023-56). A well-informed written consent was obtained from all participants according to the principles of the Declaration of Helsinki. Patients with an age range of 18-65 years, adapting to the treatment program to be applied, diagnosed with unilateral stage 2-3 AC, no shoulder trauma in the last 3 months, no shoulder injections, no bleeding disorder, no history of malignancy, inflammatory disease and stroke were included in the study. The patients were randomized into two groups according to the sealed envelope method. In the evaluation of the patients before the injection, age, gender, body mass index (BMI), occupation, education, duration of complaint, symptomatic side and dominant hand information were recorded. Injections were made to the patients by the physiatrist and anesthetist researcher under the guidance of Logiq V2 portable USG device. In the first group, 2 ml of 40 mg triamcinolone acetonide and 4 ml of 1% lidocaine injection were mixed with the posterior approach method into the shoulder joint under the guidance of USG. The second group underwent suprascapular nerve block injection with 2 ml of 40 mg triamcinolone acetonide and 4 ml of 1% lidocaine under USG guidance. In addition, pendulum and ladder-finger exercises were given to both groups as a home exercise program. Shoulder range of motion (ROM), visual analog scale (VAS) scores and Shoulder Pain and Disability Index (SPADI) scores were compared before the injection, on the tenth day after the injection and at the third month after the injection.

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
Single (Investigator)

盲法说明

assessor blinded

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • unilateral stage 2-3 AC
  • no shoulder trauma in the last 3 months
  • no shoulder injections
  • no bleeding disorder
  • no history of malignancy
  • no history of inflammatory disease
  • Exlusion Criteria:
  • malignancy
  • inflammatory disease

排除标准

  • 未提供

研究组 & 干预措施

suprascapular verve block

Experimental

2 ml of 40 mg triamcinolone acetonide and 4 ml of 1% lidocaine

干预措施: 2 ml of 40 mg triamcinolone acetonide and 4 ml of 1% lidocaine (Drug)

intraarticular shoulder injection

Experimental

2 ml of 40 mg triamcinolone acetonide and 4 ml of 1% lidocaine

干预措施: 2 ml of 40 mg triamcinolone acetonide and 4 ml of 1% lidocaine (Drug)

结局指标

主要结局

Changes from baseline in pain on The Shoulder Pain and Disability Index (SPADI) at the tenth day after the injection

时间窗: baseline and on the tenth day after the injection

SPADI is a valid and reliable questionnaire used in shoulder disorders. Possible scores range from 0 (no pain) to 100 (severe shoulder pain)= Changes tenth day after the injection-baseline

The effectiveness of suprascapular nerve block on pain is higher than intra-articular

时间窗: between before treatment and on the tenth day after the injection

Shoulder Pain and Disability Index

次要结局

未报告次要终点

研究者

发起方
Hitit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayse Gulsen Dogan

Specialist Doctor

Hitit University

研究点 (2)

Loading locations...

相似试验