Clinical Pain Assessment Via Force Measurement Using the eEgg in the Setting of Routine Elective Lumbar Facet Joint Blocks (SMeEgg): a Prospective, Randomized, Two-arm Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Comparison of the expressions of pain ratings in eEgg-Arm and in NRS-Arm
研究概览
简要总结
The emotion Egg, or "eEgg" for short, is a sample series of a device for testing a new pain measurement method that is not yet on the market. The aim is to investigate whether the trial device and the eEgg method (eEgg plus software) are suitable for supporting, improving or even replacing the communication between doctor and patient, which still takes place via the numerical rating scale (NRS) and the pain diary. Issues of acceptability in comparison to the pain diary and the NRS are to be considered. Measurements should be recorded in real time; no orientation to the previous value is possible for the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Elective interventional blockade of lumbar facet joints due to lumbar facet osteoarthritis
- •Chronic pain (>3 months, most severe pain on motion in the last three months ≥3 (NRS))
- •Age ≥18 years
- •Legal capacity
- •Proficiency in the German language
- •Presence of a written informed consent from the patient
- •Inpatient pain patient
排除标准
- •Participation in other interventional trials
- •Individuals who have a dependent/employee relationship with the sponsor or investigator
- •Cognitive impairment that could affect the use of the eEgg
- •Impaired fist closure and/or reduction of gross strength in the hand area
- •mono- or poly-neuropathy in the hand area
- •Allergy to plastics
研究组 & 干预措施
NRS-Arm
Patients are asked to document their current pain at hourly intervals for 24 hours (starting from the end of the intervention) according to the usual clinical routine. The first measurement is taken before the intervention.
干预措施: NRS (Other)
eEgg-Arm
Within the 24h interval, pain assessment is performed hourly using the NRS (during the day) and the eEgg (preferably at hourly intervals throughout the day). If necessary, additional measurements can be taken with the eEgg.
干预措施: eEgg (Device)
结局指标
主要结局
Comparison of the expressions of pain ratings in eEgg-Arm and in NRS-Arm
时间窗: immediately after blockade for 24 hours
For the analysis of pain ratings using eEgg versus NRS (numerical rating scale, values 0-10 \[0=no pain - 10=the most severe pain imaginable\]), functional data analysis methods are used to account for the longitudinal structure of the data. In a first step, the pain rating measurements are transformed into continuous smooth curves based on B-spline basis functions. Then, a functional principal component analysis based on the fitted curves is performed to analyze the temporal variation. Suitable statistical measures (median/mean, quartiles/standard deviation, etc.) are used to describe the primary target variable. If necessary, a suitable statistical test follows, such as the Mann-Whitney U test for the group comparison.
次要结局
- Number of measurements with the eEgg during the night(immediately after blockade for 24 hours)
- Comparison of the expressions of the pain ratings within eEgg-Arm(immediately after blockade for 24 hours)
- Comparison of pain rating by NRS from eEgg-Arm with pain rating by NRS from NRS-Arm(immediately after blockade for 24 hours)
- Comparison of the standardization values in the eEgg group at the beginning of the study(before the blockade)
- Comparison of the standardization values in the eEgg group at the end of the study(24 hours after the blockade)
- Questionnaire evaluation on the handling of the eEgg(24 hours after the blockade)
- Difference in pain sensation (NRS) due to the different local anesthetics(immediately after blockade for 24 hours)