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

NCT05881551 | Completed

• 1 other identifier: SMeEgg
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Measurement

Keywords

pain measurement; blockade of the lumbar facet joints; peri-interventional; grip strenth; chronic pain

Outcome Measures

Primary Outcomes (1)

• Comparison of the expressions of pain ratings in eEgg-Arm and in NRS-Arm

  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.

  immediately after blockade for 24 hours

Secondary Outcomes (7)

• Comparison of the expressions of the pain ratings within eEgg-Arm

  immediately after blockade for 24 hours

• Comparison of pain rating by NRS from eEgg-Arm with pain rating by NRS from NRS-Arm

  immediately after blockade for 24 hours

• Number of measurements with the eEgg during the night

  immediately after blockade for 24 hours

• Comparison of the standardization values in the eEgg group at the beginning of the study

  before the blockade

• Comparison of the standardization values in the eEgg group at the end of the study

  24 hours after the blockade

Study Arms (2)

eEgg-Arm

EXPERIMENTAL

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.

Device: eEgg

NRS-Arm

OTHER

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.

Other: NRS

Interventions

eEgg DEVICE

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.

eEgg-Arm

NRS OTHER

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).

NRS-Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Witten/Herdecke: lead

Study Sites (1)

Helios Universitätsklinikum Wuppertal

Wuppertal, 42283, Germany

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Cegla, Dr.

  Helios University Hospital Wuppertal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 31, 2023
• Study Start: May 22, 2023
• Primary Completion: January 8, 2024
• Study Completion: January 8, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

DE (1)