Two Measures of Tactile Acuity in CRPS Type I Patients

Comparison of Two Measures of Tactile Acuity in CRPS Type I Patients , Patients With a Neuropathy of the Median Nerve and Healthy Controls.

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Controls; CRPS Type I of the Upper Extremity; Neuropathy of the Median Nerve
• Intervention / Treatment: Other: Tactile acuity measured by 2PD and the GOT

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bochum, Germany, 44789
    • Recruiting
    • Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH
    • Contact: Christoph Maier, Prof. Dr.; Phone Number: +49 2343023402; Email: Christoph.Maier@rub.de
    • Contact: Marianne David, Dr.; Phone Number: +49 2343023324; Email: Marianne.David@rub.de
    • Principal Investigator: Christoph Maier, Prof.Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum
• Investigators: Study Chair: Christoph Maier, Prof. Dr., Ruhr University Bochum

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ANTICIPATED): September 1, 2013
• Study Completion (ANTICIPATED): September 1, 2013

Study Registration Dates

• First Submitted: June 25, 2013
• First Submitted That Met QC Criteria: June 27, 2013
• First Posted (ESTIMATE): June 28, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 2, 2013
• Last Update Submitted That Met QC Criteria: August 1, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: CRPS Type I; tactile acuity; 2-point-discrimination; Grating Orientation Task; sensory signs
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy
• Other Study ID Numbers: GOT_CRPS2013