Efficacy of Ultrasound-guided Percutaneous Neuromodulation Versus Ultrasound-guided Dry Needling of the Suprascapular Nerve in Shoulder Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Muscle Force
研究概览
简要总结
Background: nonspecific shoulder pain is very common and the symptoms can persist for 6 to 12 months in half of patients. Ultrasound-guided Percutaneous Neuromodulation (US-guided PNM) is an intervention based in an electrical stimulation of a peripheral nerve through a needle located close to the target nerve by the use of an ultrasound guidance.
Objectives: the primary aim is to determine changes in strength after US-guided PNM or Ultrasound-guided Dry Needling (US-guided DN) intervention in the Suprascapular Nerve (SN) as well as its effectiveness in changes of muscle function, pain and disability.
Methods: randomised clinical trial (ratio 1:1), single-blind (examiners), parallel, with assessment of third parties. 62 adult participants with unilateral mechanical chronic nonspecific shoulder pain with at least 3-month evolution and shoulder muscle weakness will randomised to one of two procedures: US-guided PNM or US-guided DN. It will be assessed muscle strength, muscle function, pain and disability before, just after, a week and a month after the intervention.
详细描述
Shoulder pain is the third reason for medical consultation in the world. Many treatment techniques have been proposed. Neuromodulation techniques through the application of an analgesic electric current using a needle as an electrode, are increasingly used in the treatment of pain.
In this study, the investigators will compare whether the application of a neuromodulation technique is more effective than applying the dry needling technique in isolation.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic mechanical unilateral shoulder pain of non-specific origin of at least 3 months of evolution
- •Weakness in the abduction force and / or external rotation of the shoulder.
排除标准
- •Previous shoulder surgery.
- •Previous history of shoulder dislocation
- •Whiplash.
- •Cervical radiculopathy.
- •Total rupture of the rotator cuff.
- •Adhesive capsulitis.
- •Fibromyalgia diagnosis.
- •Diabetes.
- •Needle phobia or some contraindication for dry needling (anticoagulants or psychiatric disorders).
- •Bilateral shoulder pain.
- •Pregnancy or having received a dry puncture in the shoulder region in the last 6 months
结局指标
主要结局
Muscle Force
时间窗: Change from Baseline force at 6 month
Force will be measured by a manual dynamometer (microFET®2, Hoggan Scientific LLC). Measurements will be taken in Newtons (N). It will be evaluated in the movements of external rotation and abduction of both shoulders. Manual dynamometry has proven to be a tool with excellent intra-examiner reliability to assess isometric force in external rotation of the shoulder, with an intraclass correlation coefficient (ICC) of 0.96 (0.93-0.98). The minimum value is 0 and de Maximum values is 55
次要结局
- Disability(Change from Baseline disability at 6 month.)
- Muscle function(Change from Baseline muscle function at 6 month.)
- Shoulder Pain(Change from Baseline pain at 6 month.)
研究者
Prof. Dr. Daniel Pecos Martín
Clinical professor
University of Alcala