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临床试验/NCT06158568
NCT06158568已完成不适用

Effects of Percutaneous Electrical Nerve Stimulation and Exercise for Patients With Subacromial Pain Syndrome

César Fernández-de-las-Peñas1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
59
试验地点
1
主要终点
Changes in disability between baseline and follow-up periods

研究概览

简要总结

Based on the available literature, application of percutaneous electrical nerve stimulation interventions targeting peripheral nerves (also called percutaneous neuromodulation) has shown positive effects for improving pain-related and functional outcomes in musculoskeletal chronic pain. Studies investigating the use of this intervention for the shoulder are lacking.

详细描述

Based on the available literature, application of percutaneous electrical nerve stimulation interventions targeting peripheral nerves (also called percutaneous neuromodulation) has shown positive effects for improving pain-related and functional outcomes in musculoskeletal chronic pain. Studies investigating the use of this intervention for the shoulder are lacking.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Unilateral non-traumatic shoulder pain (positive painful arc during shoulder abduction and a positive Hawkins test on clinical examination)
  • •Shoulder pain from at least 3 months
  • •Shoulder pain of more than 3/10 points on a NPRS

排除标准

  • •Bilateral shoulder symptoms
  • •Younger than 18 or older than 65 years
  • •History of shoulder traumatisms, fractures or dislocation
  • •Diagnosis of cervical radiculopathy or myelopathy
  • •Previous interventions with steroid injections in the shoulder area
  • •Comorbid medical conditions, e.g., fibromyalgia syndrome
  • •Previous history of shoulder or neck surgery
  • •Any type of intervention for the neck-shoulder area during the previous year
  • •Fear to needles

研究组 & 干预措施

Percutaneous Electrical Nerve Stimulation

Experimental

Participants assigned to this group will received four sessions (once per week) of ultrasound guided percutaneous electrical nerve stimulation targeting the axillar and suprascapular nerves for 30 minutes. We will apply a biphasic compensated electrical current at a frequency of 2 Hz, a pulse width of 250 μs and intensity allowed over a pain-free motor threshold (muscle contraction). In addition, they will receive a program of exercises for the shoulder musculature for 3 weeks.

干预措施: Percutaneous Electrical Nerve Stimulation (Other)

Percutaneous Electrical Nerve Stimulation

Experimental

Participants assigned to this group will received four sessions (once per week) of ultrasound guided percutaneous electrical nerve stimulation targeting the axillar and suprascapular nerves for 30 minutes. We will apply a biphasic compensated electrical current at a frequency of 2 Hz, a pulse width of 250 μs and intensity allowed over a pain-free motor threshold (muscle contraction). In addition, they will receive a program of exercises for the shoulder musculature for 3 weeks.

干预措施: Exercise (Other)

Placebo Percutaneous Nerve Stimulation

Placebo Comparator

Participants assigned to this group will received four sessions (once per week) of placebo ultrasound guided percutaneous electrical nerve stimulation targeting the axillar and suprascapular nerve. The electrical current will be off and no electrical current will be provided to the patient. In addition, they will receive the same program of exercises for the shoulder than the experimental group for three weeks.

干预措施: Placebo Percutaneous Electrical Nerve Stimulation (Other)

Placebo Percutaneous Nerve Stimulation

Placebo Comparator

Participants assigned to this group will received four sessions (once per week) of placebo ultrasound guided percutaneous electrical nerve stimulation targeting the axillar and suprascapular nerve. The electrical current will be off and no electrical current will be provided to the patient. In addition, they will receive the same program of exercises for the shoulder than the experimental group for three weeks.

干预措施: Exercise (Other)

Exercise

Active Comparator

Participants assigned to this group will receive the same program of exercises for the shoulder than the remaining groups for three weeks.

干预措施: Exercise (Other)

结局指标

主要结局

Changes in disability between baseline and follow-up periods

时间窗: Baseline, one week after the last intervention and 1 and 3 months after the intervention

The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain

次要结局

  • Changes in shoulder pain between baseline and follow-up periods(Baseline, one week after the last intervention and 1 and 3 months after the intervention)
  • Changes in sleep quality between baseline and follow-up periods(Baseline, one week after the last intervention and 1 and 3 months after the intervention)
  • Changes in anxiety/depressive symptoms between baseline and follow-up periods(Baseline, one week after the last intervention and 1 and 3 months after the intervention)

研究者

发起方
César Fernández-de-las-Peñas
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

César Fernández-de-las-Peñas

Clinical Professor

Universidad Rey Juan Carlos

研究点 (1)

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