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

University of Witten/Herdecke

Status: Completed

Conditions: Pain Measurement

Treatments: Device: eEgg; Other: NRS

Study type: Interventional

Funder types: Other

Identifiers

NCT05881551

SMeEgg

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

53 participants in 2 patient groups

eEgg-Arm

Experimental group

Description:

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.

Treatment:

Device: eEgg

NRS-Arm

Other group

Description:

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.

Treatment:

Other: NRS