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

NCT ID: NCT05881551

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-22
• Study Completion Date: 2024-01-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

eEgg-Arm

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.

Group Type: EXPERIMENTAL

eEgg

Intervention Type: 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.

NRS-Arm

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.

Group Type: OTHER

NRS

Intervention Type: 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).

Interventions

eEgg

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.

Intervention Type: DEVICE

NRS

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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Witten/Herdecke

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Cegla, Dr.

Role: PRINCIPAL_INVESTIGATOR

Helios University Hospital Wuppertal

Locations

Helios Universitätsklinikum Wuppertal

Wuppertal, , Germany

Countries

Germany

Other Identifiers

SMeEgg

Identifier Type: -

Identifier Source: org_study_id