Evaluation of the Effect of Reiki on Pain After Spinal Fusion: A Comparative, Randomized, Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pain will be assessed at Day 15 using the VAS ( Visial Analog Scale)
研究概览
简要总结
This study involves patients undergoing lumbar spine surgery (lumbar arthrodesis). It compares the effects of Reiki, an energy-based therapy, with conventional approaches to relieve postoperative pain.
The goal is to determine whether this non-drug method can help reduce pain, limit the use of painkillers, and enhance patient comfort during recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Subject aged 18 years or older;
- •Referred for a lumbar fusion of up to 3 levels.
- •Absence of participation in another clinical study.
- •Subject affiliated with a social security scheme or beneficiary of such a scheme
排除标准
- •Neuropathic patient
- •Presence of neuropathic pain
- •Diagnosis of fibromyalgia
- •Received therapeutic touch, polarity therapy, or professional massage therapy in the past four weeks
- •Unable to undergo medical follow-up for the study
- •Adult subject protected by law, under guardianship or trusteeship
研究组 & 干预措施
standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Reiki)
treatment with reiki session
干预措施: reiki (Other)
standard treatment (analgesic + kinesitherapy sessions) + Treatment session (Sham)
treatment with sham session
干预措施: Sham (No Treatment) (Other)
结局指标
主要结局
pain will be assessed at Day 15 using the VAS ( Visial Analog Scale)
时间窗: DAY 15
The Visual Analog Scale is a subjective measurement tool commonly used to assess the intensity of pain. It consists of a horizontal 10-centimeter line on which the patient marks a point that reflects their experience. Minimum and maximum values: 0 = complete absence of the symptom 10 = the most severe imaginable intensity of the symptom Score interpretation: Higher scores indicate greater symptom intensity Lower scores indicate lesser intensity
次要结局
- Quality of life will be assessed using the SF12(DAY 30)
- Daily pain intensity will be reported(from Day 1 to Day 30)
- evaluation of patient's overall satisfaction and treatment response(at Day 30)
- Assessment of the condition of the scar at the lumbar level(at Day 15 and Day 30)
- antalgic consumption will be reported(from day 1 to day 30)
- Quality of life will be assessed using the SF12(DAY 30)
- Daily pain intensity will be reported(from Day 1 to Day 30)
- evaluation of patient's overall satisfaction and treatment response(at Day 30)
- Assessment of the condition of the scar at the lumbar level(at Day 15 and Day 30)
- antalgic consumption will be reported(from day 1 to day 30)