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

Not Applicable

Completed

• Conditions: Pain Measurement
• Interventions: Device: eEgg; Other: NRS

• Registration Number: NCT05881551
• Lead Sponsor: University of Witten/Herdecke

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-21
• Study Start: 2023-05-22
• Study First Submitted QC: 2023-05-25
• Study First Posted: 2023-05-31
• Primary Completion: 2024-01-08
• Study Completion: 2024-01-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eEgg-Arm	eEgg	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.
NRS-Arm	NRS	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.

Primary Outcome Measures

Name	Time	Method
Comparison of the expressions of pain ratings in eEgg-Arm and in NRS-Arm	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.

Secondary Outcome Measures

Name	Time	Method
Number of measurements with the eEgg during the night	immediately after blockade for 24 hours	The secondary outcome measures are evaluated using appropriate statistical measures of location (median/mean, quartiles/standard deviation, frequencies/percentages, etc.). If necessary, appropriate statistical significance tests are performed to compare measurements between the two randomization groups (e.g. for continuous data Mann-Whitney U test, e.g. for categorical data Fisher's exact test or Chi² test) or within the groups (e.g. for continuous data sign test, e.g. for categorical data McNemar test).
Comparison of the expressions of the pain ratings within eEgg-Arm	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.
Comparison of pain rating by NRS from eEgg-Arm with pain rating by NRS from NRS-Arm	immediately after blockade for 24 hours	NRS: numerical rating scale, values 0-10 \[0=no pain - 10=the most severe pain imaginable\]; The secondary outcome measures are evaluated using appropriate statistical measures of location (median/mean, quartiles/standard deviation, frequencies/percentages, etc.). If necessary, appropriate statistical significance tests are performed to compare measurements between the two randomization groups (e.g. for continuous data Mann-Whitney U test, e.g. for categorical data Fisher's exact test or Chi² test) or within the groups (e.g. for continuous data sign test, e.g. for categorical data McNemar test).
Comparison of the standardization values in the eEgg group at the beginning of the study	before the blockade	The secondary outcome measures are evaluated using appropriate statistical measures of location (median/mean, quartiles/standard deviation, frequencies/percentages, etc.). If necessary, appropriate statistical significance tests are performed to compare measurements between the two randomization groups (e.g. for continuous data Mann-Whitney U test, e.g. for categorical data Fisher's exact test or Chi² test) or within the groups (e.g. for continuous data sign test, e.g. for categorical data McNemar test).
Comparison of the standardization values in the eEgg group at the end of the study	24 hours after the blockade	The secondary outcome measures are evaluated using appropriate statistical measures of location (median/mean, quartiles/standard deviation, frequencies/percentages, etc.). If necessary, appropriate statistical significance tests are performed to compare measurements between the two randomization groups (e.g. for continuous data Mann-Whitney U test, e.g. for categorical data Fisher's exact test or Chi² test) or within the groups (e.g. for continuous data sign test, e.g. for categorical data McNemar test).
Questionnaire evaluation on the handling of the eEgg	24 hours after the blockade	The secondary outcome measures are evaluated using appropriate statistical measures of location (median/mean, quartiles/standard deviation, frequencies/percentages, etc.). If necessary, appropriate statistical significance tests are performed to compare measurements between the two randomization groups (e.g. for continuous data Mann-Whitney U test, e.g. for categorical data Fisher's exact test or Chi² test) or within the groups (e.g. for continuous data sign test, e.g. for categorical data McNemar test).
Difference in pain sensation (NRS) due to the different local anesthetics	immediately after blockade for 24 hours	NRS: numerical rating scale, values 0-10 \[0=no pain - 10=the most severe pain imaginable\]; The secondary outcome measures are evaluated using appropriate statistical measures of location (median/mean, quartiles/standard deviation, frequencies/percentages, etc.). If necessary, appropriate statistical significance tests are performed to compare measurements between the two randomization groups (e.g. for continuous data Mann-Whitney U test, e.g. for categorical data Fisher's exact test or Chi² test) or within the groups (e.g. for continuous data sign test, e.g. for categorical data McNemar test).

Trial Locations

Locations (1)

Helios Universitätsklinikum Wuppertal; 🇩🇪 Wuppertal, Germany