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临床试验/NCT07235982
NCT07235982招募中不适用

Comparative Study Between Shoulder Anterior Capsular Block Plus Steroid Injection Versus Steroid Injection Alone for Pain Management in Adhesive Capsulitis: A Randomized Trial

Zagazig University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
pain intensity

研究概览

简要总结

Improving pain in the patients with adhesive capsulitis by comparing the effect of combined shoulder anterior capsular block and intraarticular steroid injection versus intraarticular steroid injection.

详细描述

Comparing between combined shoulder anterior capsular block and intraarticular steroid injection versus intraarticular steroid injection for enhancing pain relief in adhesive capsulitis as regards:

  • To measure analgesic parameters including: assessment of pain score by using Visual Analogue Score during 8 weeks follow up in comparison to baseline and total amount of rescue analgesic (ibuprofen) consumption.
  • To assess the Shoulder pain and Disability Index
  • To record complications of the block (local anesthetic toxicity, infection, bleeding, nerve injury)
  • Over all patient's satisfaction: The patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia).

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)

盲法说明

The outcome assessors are blind to the study groups

入排标准

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

入选标准

  • •Patients acceptance
  • •Age: 41-65 years old
  • •Sex: both sex (males or females).
  • •Physical status: American Society of Anesthesiologist (ASA) І, II.
  • •Patients attend orthopedic or pain clinic with complaint of shoulder pain and stiffness. These patients received conservative management of pain with no relief of symptoms for at least 2 weeks.

排除标准

  • •Shoulder pain due to secondary causes, e.g. acute trauma, fractures, bony deformity, glenohumeral joint pathology, acromioclavicular joint pathology and rotator cuff disorder.
  • •Patient with any contraindications of regional blocks (as coagulopathy or local infection at injection site)
  • •Patients with known history of allergy to the study drugs (bupivacaine and methylprednisolone).
  • •Advanced hepatic, renal, cardiovascular, neurologic and respiratory diseases, uncontrolled diabetes mellitus and thyroid.
  • •History of neuropathy in the involved limb or previous revision surgery.

研究组 & 干预措施

Group Shoulder anterior capsular block (SHAC)

Active Comparator

patients will receive ultrasound guided (SHAC) block combined with intraarticular steroid injection of the affected shoulder joint

干预措施: Group Group Shoulder anterior capsular block (SHAC) (Procedure)

Group intraarticular steroid injection (IASI)

Active Comparator

patients will receive intraarticular steroid injection of the affected shoulder joint

干预措施: Group intraarticular steroid injection (IASI) (Procedure)

结局指标

主要结局

pain intensity

时间窗: BEFORE STARTING PROCEDURE (0 hour)(baseline)

measured by Visual Analogue Scale (VAS) 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant

pain intensity

时间窗: 15 minutes after the procedure

measured by Visual Analogue Scale(VAS) as 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant

pain intensity

时间窗: first 6 hours postoperative

measured by Visual Analogue Scale (VAS) 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant

pain intensity

时间窗: one week after procedure

measured by Visual Analogue Scale (VAS) 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant

pain intensity

时间窗: 3 weeks after procedure

measured by Visual Analogue Scale (VAS) 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant

pain intensity

时间窗: 6 weeks after procedure

measured by Visual Analogue Scale (VAS) 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant

pain intensity

时间窗: 8 weeks after procedure

measured by Visual Analogue Scale (VAS) 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant

次要结局

  • Assessment of Shoulder Pain and Disability Index (SPADI)(baseline (0 ) and subsequently at one week, 3 weeks , 6 weeks and 8 weeks after procedure)
  • Total amount of rescue analgesia(first 24 hours)
  • patient's satisfaction(1 week after procedure)
  • Complications of SHAC block(24 hours)
  • PASSIVE AND ACTIVE RANGE OF MOTION(at baseline, first week and third week follow up post intervention.)

研究者

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

Dina Abdelhameed Elsadek Salem

principle investigator

Zagazig University

研究点 (1)

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