Two Measures of Tactile Acuity in CRPS Type I Patients

Healthy Controls Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01888783
• Other study ID #: GOT_CRPS2013
• Status: Recruiting
• Phase: N/A
• First received: June 25, 2013
• Last updated: August 1, 2013
• Start date: September 2012
• Est. completion date: September 2013

Study information

• Verified date: June 2013
• Source: Ruhr University of Bochum
• Contact: Christoph Maier, Prof. Dr.
• Phone: +49 2343023402
• Email: Christoph.Maier[@]rub.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

Intervention

Other:
• Tactile acuity measured by 2PD and the GOT
For a detailed description of the methods see "outcome measures"

Locations

Country	Name	City	State
Germany	Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH	Bochum

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Touch threshold for light touch	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.	unique measurement, duration approx. 5 minutes	No
Primary	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	unique measurement of maximal one hour duration	No
Primary	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	unique measurement of maximal half an hour duration	No