Comparative Study Between Pulsed Radiofrequency in Suprascapular Nerve or Bupivacaine Block for Chronic Shoulder Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Comparison of pain intensity after application of pulsed RF in the suprascapular nerve versus injection of a local anesthetic.
研究概览
简要总结
Comparative study between pulsed radiofrequency in suprascapular nerve or bupivacaine block for chronic shoulder pain
详细描述
Prospective, randomized, comparative study of 40 participants with chronic shoulder pain allocated into two groups. Patients in group 1 underwent pulsed RF (180sec, with a fixed temperature at 42C, twice) on the suprascapular nerve, and the other group, 2, underwent nerve block with bupivacaine (5ml). After the procedure, patients were evaluated for 3 months regarding pain intensity, shoulder range of motion and dose of rescue opioids.
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)
盲法说明
Participants were allocated to groups using a random sequence of numbers generated by computer using the Randomizer® program (www.random.org). The number of patients and the groups to which they would belong were randomly drawn. These numbers were placed in envelopes numbered from 1 to 40, which were drawn on the day of the consultation.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age over 18 years old
- •Chronic shoulder pain (more than 3 months)
- •Clinical and imaging diagnosis: rotator cuff injury, adhesive capsulitis, supraspinatus, tendinopathy, bicipital tendinitis, impingement syndrome, subscapularis tendinopathy, , subacromial and subdeltoid arthrosis, acromioclavicular arthrosis, subdeltoid subacromial bursitis
- •Pain intensity ≥4 on movement, on a numerical scale from zero to 10 (where zero means no pain and 10 the most intense pain imaginable).
排除标准
- •Arrhythmia
- •Cognitive change (inability to answer questions)
- •Psychiatric illness
- •Infection at the site of the procedure
- •Coagulopathy,
- •Use of anticoagulants
- •Hypersensitivity to medications
- •Use of pacemaker
研究组 & 干预措施
Pulsed Radiofrequency
The investigators performed pulsed radiofrequency in the suprascapular nerve
干预措施: Pulsed radiofrequency (Procedure)
Bupivacaine
The investigators performed a blocade with bupivacaine in the suprascapular nerve.
干预措施: Suprascapular nerve block with bipuvacaine (Drug)
结局指标
主要结局
Comparison of pain intensity after application of pulsed RF in the suprascapular nerve versus injection of a local anesthetic.
时间窗: 12 months
Comparison of pain intensity after application of pulsed RF to the suprascapular nerve and after injection of a local anesthetic. The numerical pain scale (Visual Analogue Scale - VAS) at rest and during movement was used. This scale (VAS) ranges from 1 to 10, with 1 representing mild pain and 10 representing severe pain.
次要结局
- Need for additional analgesic.(12 months)
- To assess the range of motion of the shoulder joint(12 months)
- Duration of the analgesic effect.(12 months)
研究者
Leonardo Henrique Cunha Ferraro
Professor
Federal University of São Paulo