Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study in Participants Who Hospitalized in Department of Internal Medicine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- efficacy of BFA
研究概览
简要总结
This is a randomized sham controlled study that will include patients hospitalized in the internal medicine department and the orthopedics department at Bnei Zion Hospital presenting with pain from various sources with an NRS level equal to or above 4.
详细描述
All patients will complete pain assessment according NSR and ESAS after treatment ( SHAM or BFA) one hour before and every 24 hours until discharge.
If there was no sufficient improvement in pain within 24 hours (decrease of 1.5 points or more in NRS) - additional acupuncture will be performed in the contralateral ear and repeated assessments as above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Pain of skeletal muscle origin (Musculoskeletal MSK)/rheumatological/orthopedic syndromes 2.Visual Analog Score (VAS) grade 4 or higher before receiving the treatment.
- •3.Eligible to participate in the study according to the assessment of the investigator
排除标准
- •Pain syndromes of non-muscular bony/rheumatological/orthopedic origin
- •Planned an MRI next week
- •An infectious process in the ear planned for acupuncture or a history of sensitivity to metal
- •have any participant condition that ' according to the Investigator ' could interfere with the conduct of the trial -
研究组 & 干预措施
sham controlled arm
干预措施: accupunture (Other)
battlefield acupunture
干预措施: accupunture (Other)
结局指标
主要结局
efficacy of BFA
时间窗: two years
Evaluating the analgesic efficacy of BFA in addition to the standard treatment for pain - Standard of care (SOC) to reduce pain in patients hospitalized in the internal and orthopedic department who experience pain of moderate intensity and above compared to SHAM BFA.
次要结局
未报告次要终点
研究者
shira.ginsberg
MD
Bnai Zion Medical Center