CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 162 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03966677
NCT03966677N/ACompleted

Sensory Abnormalities in Post-surgical Peripheral Neuropathy: A Comparison of Subjects With and Without Severe Pain Using Normative Data

University of Copenhagen·observational·Posted May 29, 2019·Updated Feb 22, 2024

In Brief

An observational study for Chronic Pain. Completed, enrolled 162 participants across 1 site.

Detailed Summary

The concept of normality is a cornerstone in medical practice and research. As an example, in clinical chemistry, a laboratory value based on a plasma sample exceeding the +/- 1.96 x standard deviation (SD) range, referenced from normative material, is, per definition, outside the normal range (the reference interval). Obviously, a number of reasons for this deviation may exist. The sample value could reflect a "true" pathological condition but could also be caused by error, e.g., technical measurement error, drug-interaction error, random error, or reflect a value occurring in 5% of the healthy population. Conversely, a sample value in the normal range evidently does not exclude a pathological condition. The reference interval is calculated from a large number of healthy subjects sampled across age, anthropometrics, ethnicity, and gender. Normative reference intervals are certainly of help, particularly in the screening of subjects, but may be of limited value in the detailed assessment of pathophysiological processes. Also, increasing the number of analyses in a subject expands the risk of making a type I error (acquiring "false" positive results). The likelihood of one or more type I errors in the analysis of 10 different laboratory values in one subject is impressive 46% (\[1 - 0.95\^10\] =0.46). It is well-known that multiple measurements are commonly performed in medical practice and research, but corrected significance levels are not always used.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMay 29, 2019
Enrollment StartJul 1, 2019
Primary CompletionJun 28, 2022
Study CompletionSep 1, 2023
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.1 years ago