NCT05881551

Pain Assessment Via Force Measurement Using eEgg After Blockade of the Lumbar Facet Joints

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: University of Witten/Herdecke · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pain Measurement

Interventions

Type	Name	Description
DEVICE	eEgg	In the eEgg-Arm, patients are given the eEgg immediately before the intervention to familiarize themselves with this method. Here, the patient is asked to press the device with maximum force for five seconds, which would correspond to an NRS value of 10, and to press the eEgg only with half force, which corresponds to an NRS value of 5. Following the instruction, the current pain score present is recorded and documented using the NRS and the eEgg. The same procedure takes place at the end of the 24h observation interval when the eEgg is returned. 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.
OTHER	NRS	Patients record their pain on the numeric rating scale (NRS) within the 24-hour interval. An interval from 0 to 10 is given (0 = no pain, 10 = most pain imaginable).

Timeline

• Start date: 2023-05-22
• Primary completion: 2024-01-08
• Completion: 2024-01-08
• First posted: 2023-05-31
• Last updated: 2024-03-25

Locations

1 site across 1 country: Germany