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临床试验/NCT06713005
NCT06713005尚未招募不适用

The Clinical Efficacy of Different Durations of Suprascapular Nerve Pulsed Radiofrequency Treatment in Chronic Soulder Pain

Ankara University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1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
尚未招募
入组人数
30
试验地点
1
主要终点
Postprocedure 3th month pain severity

研究概览

简要总结

Chronic shoulder pain due to impingement syndrome and supraspinatus tendinosis is a debilitating condition. Suprascapular nerve innervates most part of shoulder joint. Supraspinatus nerve block can be used as a part of pain therapy. However, its efficacy is short-lasting. To prolong analgesia, short bursts of electrical stimulation to suprascapular nerve may be applied. To the date there is no consensus about duration of these type of stimulation. Investigators' aim is to investigate efficacy of two different duration of stimulation (pulsed radiofrequency) on chronic shoulder pain.

详细描述

Pulsed radiofrequency (pRF) treatment of suprascapular nerve can be used successfully to alleviate pain due to shoulder impingement syndrome and supraspinatus tendinosis. Radiofrequency waves produced by radiofrequency (RF) generator through pRF modality are applied to suprascapular nerve and create magnetic field. This field leads to pain modulation by changing neuronal activity and resulting in long term depression of pain transmitting nerve fibers. Temperature around nerve never exceeds 42 degree and by this way the nerve can be protected from coagulation necrosis and demiyelinisation. pRF can be used in the treatment of mixed type nerves such as suprascapular nerve. There are preclinical and clinical studies which report that with longer pRF duration, more favorable analgesia. Suprascapular pRF is performed with 22G, 10 cm, 5 mm active lead RF needle via USG guided posterior approach as institution procotol. Howeveri clinicians can choose any duration of pRF. Instution's pain medicine practitioners HAU and GEO choose 4 and 9 minutes of pRF duration, respectively. Investigators' aim is to investigate the efficacy of two different pRF duration, 4 and 9 minutes, on Shoulder Pain and Disability Index (SPADI) and Numeric Rating Scale-11(NRS-11) at 3 month follow-up.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged 18-80 years
  • •Shoulder pain caused by impingement syndrome
  • •Shoulder pain due to supraspinatus tendinosis
  • •Diagnosis of impingement syndrome and supraspinatus tendinosis confirmed through physical examination and radiological imaging (MRI)
  • •Pain persisting for 3 months or longer
  • •Numeric Pain Rating Scale (NRS) score of 4 or higher despite conservative treatment

排除标准

  • •Patients unwilling to participate in the study
  • •Presence of chronic pain due to other conditions
  • •Presence of cervical radiculopathy
  • •History of opioid use
  • •Uncontrolled diabetes (HbA1c > 8)
  • •History of shoulder surgery on the affected side
  • •Uncontrolled psychiatric disorders despite medical treatment
  • •History of cancer
  • •History of stroke

研究组 & 干预措施

4 min suprascapular pulsed RF

Other

Suprascapular nerve pulsed RF is applied for 4 minutes.

干预措施: suprascapular nerve block and 4 mins Pulsed radiofreuency application to suprascapular nerve (Procedure)

9 min suprascapular pulsed RF

Other

Suprascapular nerve pulsed RF is applied for 8 minutes.

干预措施: suprascapular nerve block and 9 mins Pulsed radiofreuency application to suprascapular nerve (Procedure)

结局指标

主要结局

Postprocedure 3th month pain severity

时间窗: From procedure to 3 months after prodecure

Severity of pain will be assessed with Numeric Rating Scale (NRS-11) at baseline, 1 weeks, 1 months and 3 months after interventions. NRS-11 is a 11 point likert type scale. Higher scores represent more severe pain.

次要结局

  • Postprocedure pain severity at first week(From procedure to 1 week after procedure)
  • Postprocedure first month pain severity(From procedure to 1 month after procedure)
  • Postprocedure SPADI scores at first week(From procedure to 1 week after procedure)
  • Postprocedure first month SPADI scores(From procedure to 1 month after procedure)
  • Postprocedure 3th month SPADI scores(From procedure to 3 month after procedure)

研究者

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

Hanzade Aybuke Unal

Principal Investigator

Ankara University

研究点 (1)

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