Clinical trial NCT05881551: Pain Assessment Via Force Measurement Using eEgg After Blockade of the Lumbar Facet Joints
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Measurement
Keywords: pain measurement
blockade of the lumbar facet joints
peri-interventional
grip strenth
chronic pain
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Comparison of the expressions of pain ratings in eEgg-Arm and in NRS-Arm
timeFrame: immediately after blockade for 24 hours
Secondary outcomes:
measure: Comparison of the expressions of the pain ratings within eEgg-Arm
timeFrame: immediately after blockade for 24 hours
measure: Comparison of pain rating by NRS from eEgg-Arm with pain rating by NRS from NRS-Arm
timeFrame: immediately after blockade for 24 hours
measure: Number of measurements with the eEgg during the night
timeFrame: immediately after blockade for 24 hours
measure: Comparison of the standardization values in the eEgg group at the beginning of the study
timeFrame: before the blockade
measure: Comparison of the standardization values in the eEgg group at the end of the study
timeFrame: 24 hours after the blockade
measure: Difference in pain sensation (NRS) due to the different local anesthetics
timeFrame: immediately after blockade for 24 hours
measure: Questionnaire evaluation on the handling of the eEgg
timeFrame: 24 hours after the blockade
Other outcomes:
Locations:
city: Wuppertal
country: Germany
facility: Helios Universitätsklinikum Wuppertal
Study officials:
affiliation: Helios University Hospital Wuppertal
name: Thomas Cegla, Dr.
role: PRINCIPAL_INVESTIGATOR
References: