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临床试验/NCT06857409
NCT06857409进行中(未招募)不适用

The Effect of Suprascapular Nerve Pulsed Radiofrequency Treatment on Central Sensitization and Neuropathic Pain

Gülçin Babaoğlu1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
Central Sensitization Inventory (CSI)

研究概览

简要总结

Chronic shoulder pain affects quality of life and is often associated with central sensitization, leading to treatment resistance. Pulsed radiofrequency (PRF) of the suprascapular nerve, which innervates 70% of the shoulder joint, is a promising therapy for nociceptive and neuropathic pain. This study evaluates the effects of PRF on central sensitization and neuropathic pain in chronic shoulder pain. Clinical assessments will be conducted at baseline, 1 month, and 3 months post-treatment to determine PRF's potential in reducing central sensitization and improving shoulder function.

详细描述

Chronic shoulder pain is a prevalent musculoskeletal condition affecting quality of life, with an incidence of 18-26% in the general population. Its prevalence has doubled over the past 40 years. Pain sensitization, independent of etiology, is frequently observed in patients with musculoskeletal shoulder pain and can lead to poorer clinical outcomes even after primary disease treatment. Chronic pain development involves both peripheral and central sensitization mechanisms, with central sensitization characterized by amplified pain signaling and reduced inhibitory pathway activity. This can result in pain persistence independent of tissue damage and resistance to treatment.

Conventional treatments for chronic shoulder pain include physiotherapy, nonsteroidal anti-inflammatory drugs (NSAIDs), and intra-articular steroid injections. However, these may not provide sufficient long-term analgesia, and some patients develop treatment-resistant chronic pain. Recently, pulsed radiofrequency (PRF) treatment applied to the suprascapular nerve, responsible for 70% of the sensory innervation of the shoulder joint, has gained attention for its efficacy in reducing both nociceptive and neuropathic pain. PRF modulates neural activity without causing thermal damage and may have the potential to reduce central sensitization. However, its effects on central sensitization and neuropathic pain mechanisms remain insufficiently studied.

This study aims to evaluate the impact of suprascapular nerve PRF on central sensitization and neuropathic pain in chronic shoulder pain. Clinical assessments will be conducted at baseline, 1 month, and 3 months post-treatment to examine changes in central sensitization, neuropathic pain, and shoulder function. This study seeks to determine whether PRF can serve as an effective alternative in chronic shoulder pain management by reducing central sensitization and improving quality of life.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • •Chronic shoulder pain persisting for at least 3 months
  • •Radiologically confirmed shoulder lesions, including:
  • •Rotator cuff tendinopathy Adhesive capsulitis Bursitis Osteoarthritis
  • •At least two positive provocation tests (Neer, Hawkins, Jobe tests)
  • •Shoulder pain resistant to conservative treatments, including:
  • •Nonsteroidal anti-inflammatory drugs (NSAIDs) Physical therapy Corticosteroid injections

排除标准

  • •Traumatic shoulder pain (e.g., fractures, dislocations)
  • •History of shoulder surgery
  • •Active inflammation or rheumatic diseases affecting the shoulder, including:
  • •Rheumatoid arthritis Polymyalgia rheumatica Ankylosing spondylitis
  • •Cervical radiculopathy
  • •Central nervous system diseases, such as:
  • •Multiple sclerosis Stroke Spinal cord injury

研究组 & 干预措施

suprascapular nerve pulsed radiofrequency

patients undergoing suprascapular nerve pulsed radiofrequency therapy

干预措施: pulsed radiofrequency (Procedure)

结局指标

主要结局

Central Sensitization Inventory (CSI)

时间窗: baseline, 1st and 3rd months

The CSI will be used to assess symptoms related to CS. The CSI will consist of two parts, Part A and Part B. Part A will include 25 items scored on a scale from 0 to 100, with higher scores indicating an increased CS-related symptom burden. In Part B, diagnoses of central sensitivity syndromes will be questioned, and this part will not be included in the scoring.

次要结局

  • Douleur Neuropathique 4 (DN4) Questionnaire(baseline, 1st and 3rd months)
  • Numerical Rating Scale (NRS)(baseline, 1st and 3rd months)
  • Shoulder Pain and Disability Index (SPADI)(baseline, 1st and 3rd months)

研究者

发起方
Gülçin Babaoğlu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gülçin Babaoğlu

Medical doctor

Ankara City Hospital Bilkent

研究点 (1)

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