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

Overview
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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.

Programme: ZKS-UWH

SEEK ID: https://ldh.zks-uwh.imise.uni-leipzig.de/projects/4

Public web page: Not specified

NFDI4Health PALs: Katharina Graf

Project created: 3rd Jun 2025

Extended Metadata (Nfdi4Health MDS 3.3)

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Id of the project(*) : nfdi4health-30009

Resource classification(*)

Type of the resource : Study

Title(s)/name(s) of the Project

Title/name : 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
Language of the title/name : English

Acronym(s) of the Project

Acronym : SMeEgg
Language of the acronym : German

Description(s) of the Project

Description : 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.
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : pain measurement, blockade of the lumbar facet joints, peri-interventional, grip strenth, chronic pain

Language(s) of the project : German

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Organisational
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Sponsor (primary)
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : ZKS-UW/H
Details about the contributing person(s)
Contributor type(*) : Not specified
Given name(*) : Not specified
Family name(s)(*) : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : zks@uni-wh.de
Phone number : +49 202 896-5613
Organisation(s) associated with the contributor
Name(*) : Witten/Herdecke University
Address : Alfred-Herrhausen-Str., 50, 58448, Witten, Deutschland
Web page : Not specified
Digital identifier(s)
Identifier(*) : 00yq55g44
Scheme(*) : ROR

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Principal investigator
Given name(*) : Thomas
Family name(s)(*) : Cegla
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : Not specified
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Helios University Hospital Wuppertal
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : 02r8sh830
Scheme(*) : ROR
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Project manager
Given name(*) : Katharina
Family name(s)(*) : Graf
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : Not specified
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : ZKS-UW/H
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : NCT (ClinicalTrials.gov)
Identifier(*) : NCT05881551

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Parallel
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Chronic Pain in Lumbar Facet Joint Blocks
Terminology/classification(*) : ICD-10
Code of the health condition or disease : M47.8
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Diseases of the musculoskeletal system and connective tissue (XIII)
On which diseases or conditions were the data collected? : []
Collects mortality data? : Not specified
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Completed: Recruitment, data collection, and data quality management completed normally
Participants enrolled by invitation? : Yes
Start date : 22 May 2023
End date : 8 January 2024
Mono- or multicentric? : Monocentric
Number of centers : Not specified
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligible gender : Not applicable
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
Population of the Project(*)
Coverage : Regional
Country(ies) : Germany
Region(s) and/or city(ies) : Wuppertal
Interventions of the Project
Name of the intervention(*) : Pain measurement with emotion Egg
Type of the intervention : Device (including sham)
Additional information about the intervention : Not specified
Name(s) of the arm(s) associated with the given intervention : Group A
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : Comparison of the expressions of pain ratings in eEgg-Arm and in NRS-Arm
Description of the outcome measure : 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.
Type of the outcome measure : Primary
Time point(s) of assessment : immediately after blockade for 24 hours
Name of the outcome measure(*) : Comparison of the expressions of the pain ratings within eEgg-Arm
Description of the outcome measure : 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.
Type of the outcome measure : Secondary
Time point(s) of assessment : immediately after blockade for 24 hours
Name of the outcome measure(*) : Comparison of pain rating by NRS from eEgg-Arm with pain rating by NRS from NRS-Arm
Description of the outcome measure : 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).
Type of the outcome measure : Secondary
Time point(s) of assessment : immediately after blockade for 24 hours
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : Undecided, it is not yet known if data will be made available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : No
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Other
Masking of intervention(s) assignment
Masking implemented? : false
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Randomized
Off-label use of a drug product : No

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

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