Pain MeasurementSMeEggNCT05881551
Pain Assessment Via Force Measurement Using eEgg After Blockade of the Lumbar Facet Joints
A study testing eEgg and NRS in people with Pain Measurement, run by University of Witten/Herdecke at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Measurement
- What is being tested?
- eEgg and NRS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteGermany
- Study dates
- 22 May 2023to 8 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
- Being tested
- eEgg, NRS
- Keywords
- pain measurement, blockade of the lumbar facet joints, peri-interventional, grip strenth, chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eEggDevice
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.
NRSOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: NRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after blockade for 24 hours
Secondary outcomes (7)
Comparison of the expressions of the pain ratings within eEgg-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.
Measured: immediately after blockade for 24 hours
Comparison of pain rating by NRS from eEgg-Arm with pain rating by NRS from NRS-Arm
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).
Measured: immediately after blockade for 24 hours
Number of measurements with the eEgg during the night
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).
Measured: immediately after blockade for 24 hours
Comparison of the standardization values in the eEgg group at the beginning of the study
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).
Measured: before the blockade
Comparison of the standardization values in the eEgg group at the end of the study
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).
Measured: 24 hours after the blockade
Difference in pain sensation (NRS) due to the different local anesthetics
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).
Measured: immediately after blockade for 24 hours
Questionnaire evaluation on the handling of the eEgg
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).
Measured: 24 hours after the blockade
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start22 May 2023
- Primary completion8 Jan 2024
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain MeasurementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Cegla, Dr., Principal investigator, Helios University Hospital Wuppertal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881551
- Sponsor's protocol ID
- SMeEgg
- Acronym
- SMeEgg
- Status last verified
- Mar 2024
- First submitted
- 21 Apr 2023
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05881551
- Acronym / sponsor ID
- SMeEgg / SMeEgg
- Conditions
- Pain Measurement
- Keywords
- pain measurement, blockade of the lumbar facet joints, peri-interventional, grip strenth, chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eEgg-Arm | Experimental | Device: eEggWithin 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 | Other | Other: NRSPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eEggIn 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. | Device | eEgg-Arm |
| NRSPatients 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). | Other | NRS-Arm |
Primary outcome
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.
7 secondary outcomes
Comparison of the expressions of the pain ratings within eEgg-Arm
Time frame: immediately after blockade for 24 hours
Comparison of pain rating by NRS from eEgg-Arm with pain rating by NRS from NRS-Arm
Time frame: immediately after blockade for 24 hours
Number of measurements with the eEgg during the night
Time frame: immediately after blockade for 24 hours
Comparison of the standardization values in the eEgg group at the beginning of the study
Time frame: before the blockade
Comparison of the standardization values in the eEgg group at the end of the study
Time frame: 24 hours after the blockade
Difference in pain sensation (NRS) due to the different local anesthetics
Time frame: immediately after blockade for 24 hours
Questionnaire evaluation on the handling of the eEgg
Time frame: 24 hours after the blockade
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Cegla, Dr. principal investigator
Helios University Hospital Wuppertal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eEgg and NRS in people with Pain Measurement, run by University of Witten/Herdecke at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the expressions of pain ratings in eEgg-Arm and in NRS-Arm (time frame: immediately after blockade for 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.