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Two Measures of Tactile Acuity in CRPS Type I Patients

Primary Purpose

CRPS Type I of the Upper Extremity, Neuropathy of the Median Nerve, Healthy Controls

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Tactile acuity measured by 2PD and the GOT
Sponsored by
Ruhr University of Bochum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for CRPS Type I of the Upper Extremity focused on measuring CRPS Type I, tactile acuity, 2-point-discrimination, Grating Orientation Task, sensory signs

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

CRPS Type I

Median Nerve Neuropathy

Healthy Controls

Arm Description

Patients diagnosed with complex regional pain syndrome type I of the upper limb

Patients diagnosed with a neuropathy of the median nerve of the upper limb.

Healthy adult persons.

Outcomes

Primary Outcome Measures

tactile acuity as measured by 2-point-discrimination
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)
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

Secondary Outcome Measures

Full Information

First Posted
June 25, 2013
Last Updated
August 1, 2013
Sponsor
Ruhr University of Bochum
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1. Study Identification

Unique Protocol Identification Number
NCT01888783
Brief Title
Two Measures of Tactile Acuity in CRPS Type I Patients
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 Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CRPS Type I of the Upper Extremity, Neuropathy of the Median Nerve, Healthy Controls
Keywords
CRPS Type I, tactile acuity, 2-point-discrimination, Grating Orientation Task, sensory signs

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CRPS Type I
Arm Type
Experimental
Arm Description
Patients diagnosed with complex regional pain syndrome type I of the upper limb
Arm Title
Median Nerve Neuropathy
Arm Type
Active Comparator
Arm Description
Patients diagnosed with a neuropathy of the median nerve of the upper limb.
Arm Title
Healthy Controls
Arm Type
Active Comparator
Arm Description
Healthy adult persons.
Intervention Type
Other
Intervention Name(s)
Tactile acuity measured by 2PD and the GOT
Other Intervention Name(s)
2-point-discrimination (2PD), Grating Orientation Task (GOT)
Intervention Description
For a detailed description of the methods see "outcome measures"
Primary Outcome Measure Information:
Title
tactile acuity as measured by 2-point-discrimination
Description
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
Time Frame
unique measurement of maximal one hour duration
Title
tactile acuity as measured by the Grating Orientation Task (GOT)
Description
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
Time Frame
unique measurement of maximal half an hour duration
Other Pre-specified Outcome Measures:
Title
Touch threshold for light touch
Description
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.
Time Frame
unique measurement, duration approx. 5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph Maier, Prof. Dr.
Phone
+49 2343023402
Email
Christoph.Maier@rub.de
First Name & Middle Initial & Last Name or Official Title & Degree
Marianne David, Dr.
Phone
+49 2343023324
Email
Marianne.David@rub.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Maier, Prof. Dr.
Organizational Affiliation
Ruhr University Bochum
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Maier, Prof. Dr.
Phone
+49 2343023402
Email
Christoph.Maier@rub.de
First Name & Middle Initial & Last Name & Degree
Marianne David, Dr.
Phone
+49 2343023324
Email
Marianne.David@rub.de
First Name & Middle Initial & Last Name & Degree
Christoph Maier, Prof.Dr.

12. IPD Sharing Statement

Learn more about this trial

Two Measures of Tactile Acuity in CRPS Type I Patients

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