Trial document





This trial has been registered retrospectively.
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  DRKS00015334

Trial Description

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Title

Evaluation of psychometric properties of the pin prick examination according to the “International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)” by use of clinically common examination tools

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The classification of spinal cord injury (SCI) is commonly based on a standardized neurological examination referred to as the “International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)”, published by the American Spinal Injury Association (ASIA) and the International Spinal Cord Society (ISCoS). Besides a distinct motor testing, this examination also includes a comprehensive evaluation of sensory function respecting different sensory qualities (light touch and pin prick) in all dermatomes. It is assumed that the examination ideally reflects the topographic representation of spinal cord lesions and their related clinical impairments. Thus, ISNCSCI is widely used as outcome measurement in clinical trials. According to the literature available, the pin prick (PP) examination (assumed testing of the spinothalamic tract) shows the lowest intra- and interrater reliability among the different parts of ISNCSCI. This might partially be explained by the fact that in SCI centers various examination tools are used. However, ASIA currently recommends to exclusively apply a disposable safety pin for the PP. The use of several different examination tools may potentially have a negative impact on the clinical evaluation of individuals with SCI, and as a consequence, also on the appraisal of respective study results. Thus, the aim of this study is to evaluate and compare the psychometric properties, including the intra- and inter reliability, of the different examination tools, which are commonly used for PP. Therefore, both healthy and spinal cord injured subjects will be assessed by means of PP, using the most common instruments. Estimated time needed for the whole examination is 90 to 120 minutes per subject, spilt into 20 to 30 minutes for the standard ISNCSCI examination in individuals with SCI and 3 x 30 minutes for the PP examination in selected dermatomes of all study participants.

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Brief Summary in Scientific Language

ISNCSCI is a broadly recognized and accepted standard. It is used in both the clinical routine and in research. However, there are still ongoing discussions, especially concerning the technique of implementation of the PP appreciation (sharp/dull discrimination). According to ISNCSCI, it is assumed that the PP examination activates the lateral spinothalamic tract of the spinal cord. This tract represents a part of the anterolateral tract, which transmits pain (“sharp”), blunt and crude pressure (“dull”), but also sensation of temperature. According to ASIA’s latest revision of ISNCSCI in 2011, a disposable safety pin that is “stretched apart to allow testing on both ends” should be used for the PP examination.
Referring to this, a controversy affects the validity and reliability of PP. Differences in application of pressure and/or various sensory detection thresholds in different body regions are being discussed to have an impact on psychometric properties. Beyond that, a survey among SCI centers, which are part of the EMSCI network (European Multicenter Study about Spinal Cord Injury), revealed that numerous different examination tools are de facto used for assessing PP. Considering the partially huge differences between these instruments, this might also have a relevant influence on the quality of the examination. However, reliable differentiation of tract qualities is of high clinical and scientific relevance.
Accordingly, the aim of this study is to evaluate the extent of different examination tools on the results of PP, in both healthy and spinal cord injured subjects. The proportional share of correct answers regarding sharp/dull discrimination and the reliability of PP according to ISNCSCI are determined as primary outcome parameters depending on examiners and examination tools. In individuals with SCI, these parameters will be evaluated in consideration of the neurological level of injury and the sensory level on the given side.
In the first phase of the study, three trained ISNCSCI examiners will assess 20 healthy subjects using the most common examination tools for PP, based on the conducted survey. In the second phase, 20 individuals with SCI will additionally be examined pursuant to the same standards. As the first in study participation, all individuals with SCI receive a full ISNCSCI examination.
The designated examination sites for evaluation of PP are key sensory points of selected dermatomes that were chosen based on clinical considerations. The 7 included dermatomes (C5, T1, T4, T10, L4, L5, S1) are located in all relevant body regions (cervical, thoracic, abdominal, lumbar, sacral) and comprise both glabrous and hairy skin. Due to ethical considerations, the anorectal examination (S4/5) and the assessment of the perianal segment S3 are omitted. An in-house developed and custom-made software application randomly determines the side of the body and the order of dermatomes to be examined, the order of assessors, the examination tool and the stimulus (sharp or dull) to be applied.

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Organizational Data

  •   DRKS00015334
  •   2019/01/17
  •   [---]*
  •   yes
  •   Approved
  •   S-304/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   G82 -  Paraplegia and tetraplegia
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Interventions/Observational Groups

  •   20 healthy subjects, equally allocated to 4 age classes (20-29, 30-39, 40-49, 50-63).
    All of the three trained ISNCSCI examiners assess the PP appreciation in every study participant. The time interval between each examination is set from 24 hours at the minimum to 7 days at the maximum. The 7 pre-determined dermatomes are examined in random order on a randomly chosen body side by use of five different examination tools (safety pin 4 cm, safety pin 5 cm, cotton tip, Neurotip, and Transofix). Twelve stimuli (6 x sharp and 6 x dull) are randomly applied per dermatome and examination tool.
  •   • 20 individuals with subacute spinal cord injury (at least 3 months post-injury)
    • Neurological level of Injury C2 through S1
    • ASIA Impairment Scale A-D.
    Firstly, each participant is assessed according to INSCSCI. Subsequently, all of the three trained ISNCSCI examiners assess the PP appreciation in every study participant. The time interval between each examination is set from 24 hours at the minimum to 7 days at the maximum. The 7 pre-determined dermatomes are examined in random order on a randomly chosen body side by use of five different examination tools (safety pin 4 cm, safety pin 5 cm, cotton tip, Neurotip, and Transofix). Twelve stimuli (6 x sharp and 6 x dull) are randomly applied per dermatome and examination tool.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Evaluation of the effect of different examination tools on the results and the reliability of PP(pin prick), in both healthy and spinal cord injured subjects.

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Secondary Outcome

Evaluation of the effect of three different ISNCSCI examiners on the results and the reliability of PP, in both healthy and spinal cord injured subjects.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/10/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Healthy subjects and individuals with spinal cord injury at least 3 months post-injury.
Age: > 18 years.

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Exclusion Criteria

Dermatoses (infection/ inflammation, psoriasis, atopic eczema, skin burn).
Pre-existing diseases of the peripheral and/or central nervous system.
Higher cognitive impairments or psychiatric diseases.
Colonization or infection with multiresistant germs.
Pregnancy.
Lacking capacity for consent.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Heidelberg, Klinik für Paraplegiologie - Querschnittzentrum
    • Mr.  Prof. Dr.  Norbert  Weidner 
    • Schlierbacher Landstr. 200a
    • 69118  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg, Klinik für Paraplegiologie - Querschnittzentrum
    • Mr.  Dr. med.  Steffen  Franz 
    • Schlierbacher Landstr. 200a
    • 69118  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg, Klinik für Paraplegiologie - Querschnittzentrum
    • Mr.  Dr. med.  Steffen  Franz 
    • Schlierbacher Landstr. 200a
    • 69118  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Heidelberg, Klinik für Paraplegiologie - Querschnittzentrum
    • Mr.  Prof. Dr.  Norbert  Weidner 
    • Schlierbacher Landstr. 200a
    • 69118  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.