Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Two Measures of Tactile Acuity in CRPS Type I Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
CRPS Type I of the Upper Extremity Neuropathy of the Median Nerve Healthy Controls Other: Tactile acuity measured by 2PD and the GOT Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Comparison of Two Measures of Tactile Acuity in CRPS Type I Patients , Patients With a Neuropathy of the Median Nerve and Healthy Controls.
Study Start Date : September 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: CRPS Type I
Patients diagnosed with complex regional pain syndrome type I of the upper limb
 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)
Active Comparator: Median Nerve Neuropathy
Patients diagnosed with a neuropathy of the median nerve of the upper limb.
 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)
Active Comparator: Healthy Controls
Healthy adult persons.
 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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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


Other Outcome Measures:
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888783


Contacts
Layout table for location contacts
Contact: Christoph Maier, Prof. Dr. +49 2343023402 Christoph.Maier@rub.de
Contact: Marianne David, Dr. +49 2343023324 Marianne.David@rub.de

Locations
Layout table for location information
Germany
Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH Recruiting
Bochum, Germany, 44789
Contact: Christoph Maier, Prof. Dr.    +49 2343023402    Christoph.Maier@rub.de   
Contact: Marianne David, Dr.    +49 2343023324    Marianne.David@rub.de   
Principal Investigator: Christoph Maier, Prof.Dr.         
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Layout table for investigator information
Study Chair: Christoph Maier, Prof. Dr. Ruhr University Bochum
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Christoph Maier, Prof. Dr., Prof. Dr. med Christoph Maier, Head Dep. of Pain Medicine, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01888783    
Other Study ID Numbers: GOT_CRPS2013
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: June 2013
Keywords provided by Christoph Maier, Prof. Dr., Ruhr University of Bochum:
CRPS Type I
tactile acuity
2-point-discrimination
Grating Orientation Task
sensory signs
Additional relevant MeSH terms:
Layout table for MeSH terms
Reflex Sympathetic Dystrophy
Complex Regional Pain Syndromes
Autonomic Nervous System Diseases
 Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases