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Two Measures of Tactile Acuity in CRPS Type I Patients

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ClinicalTrials.gov Identifier: NCT01888783
Recruitment Status : Unknown
Verified June 2013 by Christoph Maier, Prof. Dr., Ruhr University of Bochum.
Recruitment status was:  Recruiting
First Posted : June 28, 2013
Last Update Posted : August 2, 2013
Sponsor:
Information provided by (Responsible Party):
Christoph Maier, Prof. Dr., Ruhr University of Bochum

Tracking Information
First Submitted Date  ICMJE June 25, 2013
First Posted Date  ICMJE June 28, 2013
Last Update Posted Date August 2, 2013
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2013)
  • tactile acuity as measured by 2-point-discrimination [ Time Frame: unique measurement of maximal one hour duration ]
    Thresholds on the tip of the index finger of boths hands are assessed using the method of constant stimuli. One single needle and seven pairs of needles with different spacings are tested in randomized order. After each presentation, the subject has to report the sensation of one or two needles by answering immediately "one" or "two." Each distance is presented eight times resulting in 64 single decisions. The summed responses are plotted against distance as a psychometric function for absolute threshold and get fitted by a binary logistic regression. Thresholds are taken from the fit at the distance at which 50% correct answers are given
  • tactile acuity as measured by the Grating Orientation Task (GOT) [ Time Frame: unique measurement of maximal half an hour duration ]
    Stimuli are taken from a set of dome-shaped plastic gratings with equal groove and ridge widths. Gratings are applied to the immobilized distal fingerpad of the index finger of boths hand with the ridges oriented either along or across the long axis of the finger in randomized sequences of the two alternatives. Subjects have to report the orientation of the gratings as "along" or "across". The largest groove widths in the set is 6mm, the minimal width is 0.5mm. Thresholds were taken from the groove width at which the performance was 75% correct. Unless the performance is exactly 75% for a particular grating, interpolation between gratings spanning the 75% correct responses ared used
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
  • tactile acuity as measured by 2-point-discrimination [ Time Frame: unique measurement of maximal one hour duration ]
    Thresholds on the tip of the index finger of both hands are assessed using the method of constant stimuli. One single needle and seven pairs of needles with different spacings are tested in randomized order. After each presentation, the subject has to report the sensation of one or two needles by answering immediately "one" or "two." Each distance is presented eight times resulting in 64 single decisions. The summed responses are plotted against distance as a psychometric function for absolute threshold and get fitted by a binary logistic regression. Threshold are taken from the fit at the distance at which 50% correct answers are given
  • tactile acuity as measured by the Grating Orientation Task (GOT) [ Time Frame: unique measurement of maximal half an hour duration ]
    Stimuli are taken from a set of dome-shaped plastic gratings with equal groove and ridge widths. Gratings are applied to the immobilized distal fingerpad of the index finger of boths hand with the ridges oriented either along or across the long axis of the finger in randomized sequences of the two alternatives. Subjects have to report the orientation of the gratings as "along" or "across". The largest groove widths in the set is 6mm, the minimal width is 0.5mm. Threholds were taken from the groove width at which the performance was 75% correct. Unless the performance is exactly 75% for a particular grating, interpolation between gratings spanning the 75% correct responses ared used
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 1, 2013)
Touch threshold for light touch [ Time Frame: unique measurement, duration approx. 5 minutes ]
Touch thresholds are taken from a set of von Frey filaments (0.25 mN - 512 mN). Touch sensitivity is investigated by using a staircase procedure during which subjects are required to close their eyes and report when they perceive an indentation of the skin on the fingerpad of the index finger. The applied forces are decreased in a stepwise manner until the subject no longer perceives the stimulus (lower boundary) and then increased until the stimulus is perceived again (upper boundary). This procedure is repeated 5 times resulting in 10 values that are averaged to provide the touch threshold.
Original Other Pre-specified Outcome Measures
 (submitted: June 27, 2013)
Touch threshold for light touch [ Time Frame: unique measurement, duration approx. 5 minutes ]
Touch thresholds are taken from a set of von Frey filaments(0.25 mN - 512 mN). Touch sensitivity is investigated by using a staircase procedure during which subjects are required to close their eyes and report when they perceive an indentation of the skin on the fingerpad of the indexfinger. The applied forces are decreased in a stepwise manner until the subject no longer perceives the stimulus (lower boundary) and then increased until the stimulus is perceived again (upper boundary). This procedure is repeated 5 times resulting in 10 values that are averaged to provide the touch threshold.
 
Descriptive Information
Brief Title  ICMJE Two Measures of Tactile Acuity in CRPS Type I Patients
Official Title  ICMJE Comparison of Two Measures of Tactile Acuity in CRPS Type I Patients , Patients With a Neuropathy of the Median Nerve and Healthy Controls.
Brief Summary This study aims to investigate whether two different measures of tactile acuity lead to comparable results in patients diagnosed with CRPS Type I of the upper extremity. Additionally patients with a neuropathy of the median nerve and healthy controls are included.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • CRPS Type I of the Upper Extremity
  • Neuropathy of the Median Nerve
  • Healthy Controls
Intervention  ICMJE Other: Tactile acuity measured by 2PD and the GOT
For a detailed description of the methods see "outcome measures"
Other Names:
  • 2-point-discrimination (2PD)
  • Grating Orientation Task (GOT)
Study Arms  ICMJE
  • Experimental: CRPS Type I
    Patients diagnosed with complex regional pain syndrome type I of the upper limb
    Intervention: Other: Tactile acuity measured by 2PD and the GOT
  • Active Comparator: Median Nerve Neuropathy
    Patients diagnosed with a neuropathy of the median nerve of the upper limb.
    Intervention: Other: Tactile acuity measured by 2PD and the GOT
  • Active Comparator: Healthy Controls
    Healthy adult persons.
    Intervention: Other: Tactile acuity measured by 2PD and the GOT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 27, 2013)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2013
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients diagnosed with CRPS Type I according to the "Budapest Criteria"
  • Patients diagnosed with a neuropathy of the median nerve
  • Healthy Controls,matched in age and gender to both patient cohorts

Exclusion Criteria:

  • intolerable hyperalgesia
  • lesions at the fingertips
  • high grade digit contracture
  • central neurologic disorders
  • psychiatric disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888783
Other Study ID Numbers  ICMJE GOT_CRPS2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christoph Maier, Prof. Dr., Ruhr University of Bochum
Study Sponsor  ICMJE Ruhr University of Bochum
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Christoph Maier, Prof. Dr. Ruhr University Bochum
PRS Account Ruhr University of Bochum
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP