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
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pain Measurement
- Sponsor
- University of Witten/Herdecke
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Comparison of the expressions of pain ratings in eEgg-Arm and in NRS-Arm
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Comparison of the expressions of pain ratings in eEgg-Arm and in NRS-Arm
Time Frame: immediately after blockade for 24 hours
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.
Secondary Outcomes
- Number of measurements with the eEgg during the night(immediately after blockade for 24 hours)
- 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)
- 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)
- Questionnaire evaluation on the handling of the eEgg(24 hours after the blockade)
- Difference in pain sensation (NRS) due to the different local anesthetics(immediately after blockade for 24 hours)