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临床试验/NCT06106490
NCT06106490招募中不适用

Addition of Pulsed Radiofrequency to Suprascapular Nerve Block With Glenohumeral Steroid Injection in Patients With Chronic Shoulder Pain

Ain Shams University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年11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
60
试验地点
2
主要终点
change of Shoulder Pain and Disability Index (SPADI) questionnaire in both groups after the intervention

研究概览

简要总结

The purpose of this study is to evaluate the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients focusing on both changes in pain and function scores

详细描述

Shoulder pain is the second most prevalent musculoskeletal condition in adults which is frequently treated poorly and results in chronic pain .

The use of steroid injection has been demonstrated to be superior to conventional therapies, particularly non-steroidal anti-inflammatory drugs. Its impact is transient (4-6 weeks) and occasionally may not be clinically sufficient .

An alternate analgesic injection for the pain management of numerous shoulder diseases is the suprascapular nerve block (SSN) .

Although pulse radiofrequency analgesia typically lasts for a much longer period than nerve blocking, it has become increasingly popular to apply pulse radiofrequency to peripheral nerves.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged from 21-60 years.
  • Patients with American Society of Anesthesiologists (ASA) physical status I and II.
  • Chronic shoulder pain (>3 months) and will undergo interventional treatment due to inadequate response to conservative treatments.

排除标准

  • Refusal of procedure or participation in the study by patients.
  • History of shoulder surgery, another intervention history between 3 months before and 1 year after the intervention applied.
  • Patients with chronic pain syndrome due to other shoulder pathology (fibromyalgia, cervical discopathy, brachial plexus injury).
  • Uncontrolled diabetes mellitus patients with glycated hemoglobin (HbA1C) levels of more than 7%.
  • Patients with known history of allergy to the study drugs.
  • Infection at site of injection.
  • Cognitive or psychiatric illness that will lead to inability to cooperate, speak, or provide informed consent.

研究组 & 干预措施

Suprasacapular nerve block

Active Comparator

Patients will receive ultrasound guided intra articular Gleno-humeral steroid injection of Diprofos® (betamethasone 14 mg/ 2ml) and ultrasound guided suprascapular nerve block US SSN with 10mL of 0.25% preservative-free bupivacaine

干预措施: the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients (Other)

Pulsed Radiofrequency group

Active Comparator

Patients will receive ultrasound guided intra articular Gleno-humeral steroid injection of Diprofos® (betamethasone 14 mg/ 2ml) and ultrasound guided suprascapular nerve block US SSN with 10mL of 0.25% preservative-free bupivacaine with application of pulse PRF at 42 Celsius of suprascapular nerve for 480 seconds.

干预措施: the effect of adding pulsed radiofrequency (PRF) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients (Other)

结局指标

主要结局

change of Shoulder Pain and Disability Index (SPADI) questionnaire in both groups after the intervention

时间窗: 15th day, 1st month, 3rd month and 6th month

The Shoulder Pain and Disability Index (SPADI) a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities, overall total scores range from 0 to 130 with a percentage score of 0 indicating less shoulder disability and 100 indicating more shoulder dysfunction

次要结局

  • Active range of motion (AROM).physiological parameter(15th day, 1st month, 3rd month and 6th month)
  • Duration of pain relief physiological parameter(15th day, 1st month, 3rd month and 6th month)
  • Numerical pain rating scale (NRS).physiological parameter(15th day, 1st month, 3rd month and 6th month)

研究者

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

Nahla yahia

assistant lecturer of anesthesia

Ain Shams University

研究点 (2)

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