跳至主要内容
临床试验/NCT05563571
NCT05563571招募中不适用

The Effectiveness of Pulsed Radiofrequency of the Suprascapular Nerve and Shoulder Joint Compared to Intra-articular Corticosteroid Injection for Hemiplegic Shoulder Pain Management and Functional Improvement.

Satasairaala1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年4月1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
招募中
发起方
入组人数
20
试验地点
1
主要终点
Pain at performing ADL

研究概览

简要总结

Introduction: hemiplegic shoulder pain (HSP) in a common post-stroke condition, that can lead to poor motor and functional recovery and lower quality of life. Interventions like intra-articular corticosteroid injection (ICI) and suprascapularis nerve (SSN) pulsed radiofrecuenfy treatment (PRF) has been used to treat the pain.

Methods: in this single-center, prospective, randomized controlled study, we included 20 consecutive patients with hemiplegic shoulder pain in subacute stroke phase (2-12 months after diagnosis). Subjects were randomly assigned to the PRF (SSN and shoulder joint) and ICI treatment groups (n = 10 in each). Primary outcome is hemiplegic shoulder pain severity, measured by numeric rating scale, active shoulder range of motion and Fugl-Meyer upper limb assessment. Secondary outcome is shoulder joint and cervicocephalic kinesthetic sensibility. Outcome measurements were assessed at baseline and one, two and six months after each procedure.

详细描述

Introduction Post-stroke shoulder pain is a common condition, with various etiology and outcome. The incidence is 10-22% according to a recent meta-analysis and 12 month prevalence is estimated to be 39% (1). Shoulder pain is most commonly developing within the 2-3 months after diagnosis (2), and often resolves spontaneously in 6 months period. The background of shoulder pain condition is complicated phenomenon encompassing both nociceptive and neuropathic pain etiologies (3-5). Specific musculoskeletal etiologies are associated with HSP, including rotator cuff tendinitis, adhesive capsulitis, and bicipital tendinitis, subacromial bursitis (6) while other causes are more complex like glenohumeral subluxation, spasticity, central pain (6, 7) and the causes are often overlapping (3,4).

HSP has been demonstrated to be a predictor of poor motor and functional recovery, lower quality of life and can lead to emotional problems such as depression and anxiety (8,9,10).

Generally, clinicians employ range of motion (ROM) exercises, oral medications and other modalities of therapy to control HSP (11).

Some research have showed significant benefits in terms of pain reduction for many interventions including orthoses, botulinum toxin injection, electrical stimulation, aromatherapy and acupuncture (3).

In different national guidelines and systematic reviews intra-articular corticosteroid injection (ICI) into the shoulder joint is suggested as a choice of treatment, but its effect has only a relatively short duration (12). CSI has been reported to lead adverse events such as tendon degeneration, cutaneous atrophy or infection (13-15). In addition, CSI can cause systemic side effects including changes in the hypothalamic-pituitary-adrenal (HPA) axis function and elevated blood glucose levels (16).

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)

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

入选标准

  • subacute stroke, duration 2-12 months
  • presence of hemiparesis caused by stroke and at least some active movement from the shoulder joint
  • significant shoulder pain with a minimum score of four on the numeric rating scale (NRS, where "0" indicates no pain and "10" indicates the most severe pain) persistent for at least one month with adequate other pain treatment modalities (pain killers, physical exercise).

排除标准

  • patients not willing to participate
  • significant other undelying shoulder pathology at the hemiparetic side
  • severe aphasia or cognitive dysfunction that significantly affects the understaning of procedures and co-operation

研究组 & 干预措施

Intra-articular cortisone injection

Active Comparator

Ultra-sound guided single injection of Methylprednisolon 40 mg (1 ml) + 1 ml 10 % Lidocaine to shoulder joint

干预措施: Pulsed radiofrequency, Lidocaine (Other)

pulsed radiofrequency of shoulder joint and suprascapular nerve

Active Comparator

Ultra-sound guided single treatment of shoulder joint and suprascapular nerve with pulsed radiofrequency (PRF) STP (Sluijter Teixeira pulse) 45 V 4 minutes each with 1 ml 10% Lidocaine to both shoulder joint and suprascapular nerve.

干预措施: Methylprednisolon, Lidocaine (Drug)

结局指标

主要结局

Pain at performing ADL

时间窗: Change in pain in one, two and six months after the procedure

"yes" or "no"

Pain in special movement

时间窗: Change in pain in one, two and six months after the procedure

"yes" or "no"

Pain intensity

时间窗: Change in pain intensity in one, two and six months after the procedure

Numerical Rating Scale

Pain at night

时间窗: Change in pain in one, two and six months after the procedure

"yes" or "no"

Pain at rest

时间窗: Change in pain in one, two and six months after the procedure

"yes" or "no"

Range of motion

时间窗: Change in active movement in one, two and six months after the procedure

Active flexion, active abduction and active lateral rotation measured by robotic device

Fugl-Meyer Upper limb Assessment

时间窗: Change in function in one, two and six months after the procedure

upper limb function assessed from 0 to 66, with 66 being normal neurological finding of upper limb

次要结局

  • Shoulder Joint And Neck Kinesthetic Sensibility(Change in one, two and six months after the procedure)

研究者

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

Aet Ristmägi

Medical Doctor

Satasairaala

研究点 (1)

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