Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Patient Controlled Analgesia (PCA) Hydromorphone Usage
研究概览
简要总结
The purpose of this research study is to investigate the effects of Transcranial Magnetic Stimulation on pain perception. TMS is a non - invasive technique that uses electromagnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures)
详细描述
To test whether rTMS over the left prefrontal cortex significantly reduces post-operative pain and PCA use following gastric-bypass surgery relative to sham and an active control, in a mood- independent manner. Note that the active control is still mentioned in the aims and hypotheses, but was apparently removed from the study design.
To determine the effects of timing (one immediately following surgery and one 4 hours later) and dose of TMS (0, 1, or 2 sessions of active rTMS) on post-operative pain and PCA use; To determine the effects of TMS on post-surgical recovery time (time to discharge) and clinical outcomes at 1-month, 3- months and 6-months follow-up. Again an active control is mentioned, though this was removed from the design. It appears that this aspect of the proposal was not edited to reflect the new study design.
In the new design, 108 participants received two 20 minute sessions of 10 Hz rTMS (110% of motor threshold) over the left dorsolateral prefrontal cortex (one immediately following surgery and one 4 hours later). Participants were randomly assigned to receive two sessions of real rTMS, two sessions of sham, 1 real then 1 sham, or 1 sham then 1 real rTMS treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult gastric by-pass patients 18 to 60 years old
排除标准
- •Non gastric by -pass patients.
研究组 & 干预措施
Both Real TMS
Participants in the Both Real TMS group receive 20 minutes of Real TMS 45 minutes after gastric-bypass surgery and then another 20 minutes of Real TMS 4 hours after surgery.
干预措施: Real TMS 45 min (Device)
Both Real TMS
Participants in the Both Real TMS group receive 20 minutes of Real TMS 45 minutes after gastric-bypass surgery and then another 20 minutes of Real TMS 4 hours after surgery.
干预措施: Real TMS 4 Hours (Device)
Sham then Real TMS
Participants in the Sham then Real TMS group, receive Sham TMS 45 minutes after gastric-bypass surgery and 20 minutes of Real TMS 4 hours after surgery.
干预措施: Real TMS 4 Hours (Device)
Sham then Real TMS
Participants in the Sham then Real TMS group, receive Sham TMS 45 minutes after gastric-bypass surgery and 20 minutes of Real TMS 4 hours after surgery.
干预措施: Sham TMS 45 min (Device)
Real then Sham TMS
Participants in the Real then Sham TMS group receive 20 minutes of Real TMS 45 minutes after gastric-bypass surgery and then 20 minutes of Sham TMS 4 hours after surgery.
干预措施: Real TMS 45 min (Device)
Real then Sham TMS
Participants in the Real then Sham TMS group receive 20 minutes of Real TMS 45 minutes after gastric-bypass surgery and then 20 minutes of Sham TMS 4 hours after surgery.
干预措施: Sham TMS 4 Hours (Device)
Both Sham TMS
Participants in the Both Sham TMS group, receive Sham TMS 45 minutes after gastric-bypass surgery and then another 20 minutes of Sham TMS 4 hours after surgery
干预措施: Sham TMS 45 min (Device)
Both Sham TMS
Participants in the Both Sham TMS group, receive Sham TMS 45 minutes after gastric-bypass surgery and then another 20 minutes of Sham TMS 4 hours after surgery
干预措施: Sham TMS 4 Hours (Device)
结局指标
主要结局
Patient Controlled Analgesia (PCA) Hydromorphone Usage
时间窗: Post-Op Hour 0 through 48
PCA pump usage values were reported by concentration in mg/mL. Post operative PCA pump usage was tracked 0-48 hours after surgery. The PCA pump usage was downloaded from the PCA pump after discharge from the hospital and values were reported in mg/mL (concentration in mg/mL). The PCA pump data were averaged over Post-operative hours 0-48 (total PCA pump usage post-operatively) and the mean PCA pump usage was calculated and reported in mg/mL for all groups (4).
Sensory Dimension of McGill Pain Questionnaire
时间窗: Check Up 1, Check Up 2, Check Up 3, and Check Up 4
Participants completed the McGill Pain Questionnaire-short form (MPQ) at Check Up 1, Check Up 2, Check Up 3, and Check Up 4. Check Up 1 \& 2 occurred on Post-Op Day 1. Check Up 1 occurred immediately after surgery. Check Up 2 occurred 4 hours after Check Up 1. Check Up 3 \& 4 occurred on Post-Op Day 2, 4 hours apart. The MPQ has two pain dimensions: 1.Sensory subscale with 11 words, and 2.Affective subscale with 4 words from the original MPQ. The range of scores for the affective dimension of pain is 0-12. The range of scores for the sensory dimension of pain is 0-33. The maximum total score for the sensory dimension is 33. Higher scores are indicative of worse pain on the sensory dimension of pain.
Affective Dimension of McGill Pain Questionnaire
时间窗: Check Up 1, Check Up 2, Check Up 3, and Check Up 4
Participants completed the McGill Pain Questionnaire-short form (MPQ) at Check Up 1, Check Up 2, Check Up 3, and Check Up 4. Check Up 1 \& 2 occurred on Post-Op Day 1. Check Up 1 occurred immediately after surgery. Check Up 2 occurred 4 hours after Check Up 1. Check Up 3 \& 4 occurred on Post-Op Day 2, 4 hours apart. The MPQ has two pain dimensions: 1.Sensory subscale with 11 words, and 2.Affective subscale with 4 words from the original MPQ. The range of scores for the affective dimension of pain is 0-12. The maximum total score for the Affective dimension is 12. Higher scores are indicative of worse pain on the affective dimension of pain.
次要结局
- Confidence Ratings of Guessing TMS Condition Assignment(After Second TMS Treatment (Check up 4))
- Correctly Guessed Assignment Condition at 4 Hours(After second TMS treatment (Check up 4))