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临床试验/NCT03588143
NCT03588143已完成不适用

Immediate Effects of Transcutaneous Electrical Nerve Stimulation and High Voltage Pulsed Stimulation on Subacromial Pain and Shoulder Movements

Mehmet Gürhan KARAKAYA0 个研究点目标入组 106 人开始时间: 2015年11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
106
主要终点
Change of pain-free shoulder range of motion

研究概览

简要总结

This study was performed to investigate the immediate effects of transcutaneous electrical nerve stimulation (TENS) and high voltage pulsed stimulation (HVPS) on resting pain and pain-free range of shoulder motion (pfROM) in patients with subacromial pain syndrome (SAPS).

详细描述

Transcutaneous electrical stimulation (TENS) and high voltage pulsed current/stimulation (HVPS) are both electrotherapeutic agents which can be used for pain relief in musculoskeletal conditions. Standard TENS devices usually deliver biphasic pulsed currents with a pulse duration between 50 μs and 1000 μs and pulse frequencies between 1 and 250 pps. HVPS devices are TENS-like devices which deliver direct current with twin monophasic spiked pulses of 10-500 V (500-ohm load) with a short pulse duration (microseconds). In both conventional TENS technique and HVPS for pain relief, the aim is to activate spinal gating mechanism by selectively stimulating large diameter Aβ fibers. Theoretically, high-frequency (~10-250 pps), low-intensity (nonpainful) currents are most efficient in selectively activating Aβ fibers, which is practically recognized by the user reporting 'strong but comfortable' nonpainful electrical paresthesia beneath the electrodes. There is no available evidence for the efficacy of TENS in patients with subacromial pain. Also, there has been little experimental work on the effects of HVPS on pain relief in the literature, as well as no known study for its efficacy in SAPS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

入选标准

  • 18-65 years-old
  • Pain with active shoulder movements
  • Subacromial pain for 2 weeks-2 months
  • Positive Hawkins-Kennedy and painful arc tests, infraspinatus weakness; in addition to these, for patients with partial rotator cuff tear, a negative drop-arm test
  • Neer stage 1-2

排除标准

  • Radiologically confirmed malignity
  • Acromial/acromioclavicular arthritis
  • History of fracture or surgery in the affected shoulder-arm complex
  • Clinically confirmed polyarthritis, rheumatoid arthritis, fibromyalgia, adhesive capsulitis or osteoarthritis of glenohumeral joint or subacromial region
  • Cervical/thoracal spinal problem• Neurological problems which may affect upper extremity movements or pain perception (stroke, peripheral neuropathy, brachial plexus lesion, etc.)
  • Neer stage 3 and indication for surgery
  • Usage of analgesic medication
  • Obesity (Body mass ≥30 kg/m2)
  • Contraindications for TENS or HVPS
  • Previous experience with electrophysical agents or physiotherapy
  • Pregnancy

研究组 & 干预措施

Electrical stimulation with TENS

Active Comparator

TENS with 100 Hz frequency, 65 microseconds pulse duration, in continuous pattern

干预措施: Electrical stimulation (Device)

Electrical stimulation with HVPS

Experimental

HVPS with twin spiked monophasic current at 100 pps frequency, in continuous pattern

干预措施: Electrical stimulation (Device)

Placebo electrical stimulation

Placebo Comparator

same electrode placement with other interventions, using the same electrotherapy device, without activating the device except its time unit.

干预措施: Electrical stimulation (Device)

结局指标

主要结局

Change of pain-free shoulder range of motion

时间窗: Change of pain-free shoulder range of motions from baseline at the end of 30 minutes of each intervention

Pain-free ranges of active shoulder flexion, abduction, internal and external rotation were measured by a digital inclinometer (Baseline Digital Inclinometer, 2008 New York-USA), which was calibrated on a flat surface before each measurement. All evaluations were performed before and after each modality application. All of the measurements were performed by a physiotherapist blinded to the modalities applied (placebo/TENS/HVPS).

次要结局

  • Change of pain intensity(Change of pain intensity from baseline at the end of 30 minutes of each intervention)

研究者

发起方
Mehmet Gürhan KARAKAYA
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mehmet Gürhan KARAKAYA

Principal investigator, Head of Neurological Rehabilitation Department, PT. PhD. Prof.

Muğla Sıtkı Koçman University

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