The Effect of Electrical Stimulation on Impairment of the Painful Post-Stroke Shoulder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Passive Range of Motion of Shoulder in Shoulder External Rotation
研究概览
简要总结
Examination of the effects of short-term use of TENS and t-NMES on passive pain-free ROM of the painful post-stroke shoulder. Treatments are compared with no stimulation.
详细描述
Single cohort, cross-over study. Subjects undergo passive pain-free ROM of the painful post-stroke shoulder under 3 stimulation conditions. The stimulation was delivered by a trained occupational therapist under three conditions: 10 seconds of TENS, 10 seconds of t-NMES, and 10 seconds of no stimulation. Each subject was exposed to each of the three stimulation conditions three times in a computer-generated random sequence for each outcome measure with a 5-minute wash-out period between each stimulation. This protocol is repeated for each of the two passive movements tested, shoulder abduction and shoulder external rotation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participant, Investigator, and Outcomes Assessor were masked to the particular stimulation during each range of motion assessment
入排标准
- 年龄范围
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 3 months post-stroke
- •worst shoulder pain in the last week at least 4 on the 0-10 numerical rating scale,
- •adequate cognitive ability to be able to rate their pain in the past week
排除标准
- •history of tachyarrhythmia with decreased blood pressure
- •uncontrolled seizures (defined as more than one per month)
- •an implanted electrical device
- •uncompensated hemi-neglect
研究组 & 干预措施
TENS/t-NMES/No stimulation
TENS stimulation parameters were of a symmetric waveform, a frequency of 100 Hz, and a pulse duration of 300 microseconds (EMPI 300PVTM program PPR #7) applied for 10 seconds. t-NMES parameters were a symmetric waveform with 2 second ramp-up and 2 second ramp-down, a frequency of 35Hz, and a pulse duration of 300 microseconds (EMPI 300PVTM program PPR #3). The t-NMES current intensity was set by adjusting the amplitude to yield the strongest contraction of the underlying muscles without initiating pain. Device and electrodes remained in place but no stimulation was delivered over the 10 second interval. Exposed to each stimulation 3 times for each shoulder ROM.
干预措施: t-NMES (Device)
TENS/t-NMES/No stimulation
TENS stimulation parameters were of a symmetric waveform, a frequency of 100 Hz, and a pulse duration of 300 microseconds (EMPI 300PVTM program PPR #7) applied for 10 seconds. t-NMES parameters were a symmetric waveform with 2 second ramp-up and 2 second ramp-down, a frequency of 35Hz, and a pulse duration of 300 microseconds (EMPI 300PVTM program PPR #3). The t-NMES current intensity was set by adjusting the amplitude to yield the strongest contraction of the underlying muscles without initiating pain. Device and electrodes remained in place but no stimulation was delivered over the 10 second interval. Exposed to each stimulation 3 times for each shoulder ROM.
干预措施: No stimulation (Other)
TENS/t-NMES/No stimulation
TENS stimulation parameters were of a symmetric waveform, a frequency of 100 Hz, and a pulse duration of 300 microseconds (EMPI 300PVTM program PPR #7) applied for 10 seconds. t-NMES parameters were a symmetric waveform with 2 second ramp-up and 2 second ramp-down, a frequency of 35Hz, and a pulse duration of 300 microseconds (EMPI 300PVTM program PPR #3). The t-NMES current intensity was set by adjusting the amplitude to yield the strongest contraction of the underlying muscles without initiating pain. Device and electrodes remained in place but no stimulation was delivered over the 10 second interval. Exposed to each stimulation 3 times for each shoulder ROM.
干预措施: TENS (Device)
结局指标
主要结局
Passive Range of Motion of Shoulder in Shoulder External Rotation
时间窗: 10 seconds
passive range of motion of shoulder in shoulder external rotation as measured with hand-held goniometer
Passive Range of Motion of Shoulder in Shoulder Abduction
时间窗: 10 seconds
passive range of motion of shoulder in shoulder abduction as measured with hand-held goniometer
次要结局
未报告次要终点
研究者
John Chae, MD
VP Research Instititute; Chair, Department of PM&R
MetroHealth Medical Center