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
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Condition or disease | Intervention/treatment | Phase |
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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 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 |

Arm | Intervention/treatment |
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Experimental: CRPS Type I
Patients diagnosed with complex regional pain syndrome type I of the upper limb
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Other: Tactile acuity measured by 2PD and the GOT
For a detailed description of the methods see "outcome measures"
Other Names:
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Active Comparator: Median Nerve Neuropathy
Patients diagnosed with a neuropathy of the median nerve of the upper limb.
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Other: Tactile acuity measured by 2PD and the GOT
For a detailed description of the methods see "outcome measures"
Other Names:
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Active Comparator: Healthy Controls
Healthy adult persons.
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Other: Tactile acuity measured by 2PD and the GOT
For a detailed description of the methods see "outcome measures"
Other Names:
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- 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
- 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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Contact: Christoph Maier, Prof. Dr. | +49 2343023402 | Christoph.Maier@rub.de | |
Contact: Marianne David, Dr. | +49 2343023324 | Marianne.David@rub.de |
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. |
Study Chair: | Christoph Maier, Prof. Dr. | Ruhr University Bochum |
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 |
CRPS Type I tactile acuity 2-point-discrimination Grating Orientation Task sensory signs |
Reflex Sympathetic Dystrophy Complex Regional Pain Syndromes Autonomic Nervous System Diseases |
Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases |