Use of Modulating Frequency or Increasing Intensity to Overcome Analgesic Tolerance to Transcutaneous Electrical Nerve Stimulation (TENS) in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Pressure Pain Threshold
研究概览
简要总结
The purpose of this study is to determine if changing the frequency or intensity of transcutaneous electrical nerve stimulation (TENS) can reduce the development of tolerance to TENS treatment.
详细描述
Healthy adults will come daily for 5 consecutive days to the testing room. Pressure pain thresholds (PPT) will be the outcome measure and will be used to measure the subject's pain threshold to deep mechanical pressure. Subjects will push a button to stop the PPT test when they first begin to feel a sensation of pain. The PPT test will be done before TENS application. The TENS unit will be applied based on random assignment to 1 of 5 treatment types and subjects will not be told which group they are assigned to. Those groups are: 1) placebo TENS, 2) high frequency TENS, 3) alternating frequency TENS, 4) modulated frequency TENS, or 5) high frequency TENS with increased intensity daily. The TENS unit will be applied for 30 minutes. After 20 minutes the PPT test will be completed a second time. This procedure will occur on all 5 consecutive days of testing. Data will be measured and recorded by an assessor blind to subject group. Blinding will be assessed at the end of testing on day 5.
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
- 是
入选标准
- •18-65 Years of Age (YOA)
- •no current pain condition
排除标准
- •Pregnancy
- •Cardiac pacemaker
- •Currently experiencing pain
- •Abnormal sensation in dominant forearm
- •History of seizures
- •Prior TENS use
研究组 & 干预措施
Placebo TENS
30 minute TENS treatment where the stimulation ramps slowly to zero after 45 seconds. The lights/display on the unit are identical to the Active unit.
干预措施: Transcutaneous Electrical Nerve Stimulation (Device)
High Frequency TENS
30 minute TENS treatment at 100 Hertz (HZ). Intensity set at a strong but comfortable setting and subject asked to increase intensity as tolerated every 5 minutes. Final stimulation intensity at end of Day 1 treatment used for the remainder of the treatment sessions for all 5 days.
干预措施: Transcutaneous Electrical Nerve Stimulation (Device)
Alternating frequency TENS
30 minute TENS treatment with a pre programed mode alternating from 4 Hz and 100 HZ. Intensity set at a strong but comfortable setting and subject asked to increase intensity as tolerated every 5 minutes. Final stimulation intensity at end of Day 1 treatment used for the remainder of the treatment sessions for all 5 days.
干预措施: Transcutaneous Electrical Nerve Stimulation (Device)
Modulated frequency TENS
30 minute TENS treatment at a pre programmed mode that ramps between 4 and 125 HZ over 12 seconds. Intensity set at a strong but comfortable setting and subject asked to increase intensity as tolerated every 5 minutes. Final stimulation intensity at end of Day 1 treatment used for the remainder of the treatment sessions for all 5 days.
干预措施: Transcutaneous Electrical Nerve Stimulation (Device)
High frequency TENS - increasing intensity
30 minute TENS treatment at 100 HZ. Intensity set at initial strong but comfortable setting on day one as above, then subjects asked for possible increases in intensity every 5 minutes on all five days.
干预措施: Transcutaneous Electrical Nerve Stimulation (Device)
结局指标
主要结局
Pressure Pain Threshold
时间窗: Pre TENS and post TENS at initial (day 1) and final (day 5) study visit
Pressure pain thresholds (PPTs) change score measured in kilopascal (kPa) will be assessed on the forearm using a pressure algometer. The pressure algometer is mechanical pressure applied by the research assistant at a gradual rate by pushing the device against the skin. The device has a 1 cm2 pad that is in contact with the skin. The subject has a button that they push when the pressure first becomes painful (threshold)which stops the test and the pressure amount is recorded by the research assistant. This is the amount of pressured in kPa that is required to cause a subjective pain of 1/10 on a scale of 0 (no Pain) to 10 (Maximum Pain) rating by the subject. The change score from day 1 to Day 5 is the primary outcome measure.
次要结局
未报告次要终点
研究者
Kathleen Sluka
PT, PhD
University of Iowa