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.
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
- 否
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
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
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
Aet Ristmägi
Medical Doctor
Satasairaala
