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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Overview
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Programme: SMeEgg

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

Public web page: Not specified

NFDI4Health PALs: No PALs for this Project

Project created: 3rd Jun 2025

Extended Metadata (Nfdi4Health MDS 3.3)

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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(*) : Witten/Herdecke University
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 : Not specified
Organisation(s) associated with the contributor
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
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
Terminology/classification(*) : Not specified
Code of the health condition or disease : Not specified
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : []
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? : Not specified
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 : []
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 : National
Country(ies) : Germany
Region(s) and/or city(ies) : Wuppertal
Interventions of the Project
Name of the intervention(*) : Not specified
Type of the intervention : Not specified
Additional information about the intervention : Not specified
Name(s) of the arm(s) associated with the given intervention : Not specified
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?(*) : Not specified
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? : Not specified
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 : Not specified
Masking of intervention(s) assignment
Masking implemented? : Not specified
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Not specified
Off-label use of a drug product : Not specified

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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