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Clinical Trials/NCT01915329
NCT01915329
Unknown
Not Applicable

Effects of Repetitive Electric Sensory Stimulation on Sensorimotor Performance and Pain Intensity in Complex Regional Pain Syndrome Type I

Ruhr University of Bochum1 site in 1 country50 target enrollmentFebruary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Complex Regional Pain Syndrome Type I of the Upper Limb
Sponsor
Ruhr University of Bochum
Enrollment
50
Locations
1
Primary Endpoint
static tactile 2-point-discrimination threshold
Last Updated
12 years ago

Overview

Brief Summary

The purpose of this study is to test a specific nerve stimulation protocol as therapeutic option in patients diagnosed with CRPS (complex regional pain syndrome) of the upper extremity.

Detailed Description

A specific high frequency electric stimulation is conveyed at 5 days to the affected hand. Each stimulation session lasts 45 minutes.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
February 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ruhr University of Bochum
Responsible Party
Principal Investigator
Principal Investigator

Christoph Maier, Prof. Dr.

Prof. Dr. med Christoph Maier, Head Dep. of Pain Medicine

Ruhr University of Bochum

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed with CRPS Type I

Exclusion Criteria

  • intolerable hyperalgesia
  • lesions at the fingertips
  • high grade digit contracture
  • central neurologic disorders
  • psychiatric disorders

Outcomes

Primary Outcomes

static tactile 2-point-discrimination threshold

Time Frame: before and after the 5 day stimulation phase with a minimum time of 1h between measurements and start/end of the stimulation (day1 pre and day 5 post)

Thresholds on the tip of the index finger of both 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. Threshold are taken from the fit at the distance at which 50% correct answers are given.

Secondary Outcomes

  • pain intensity(before and after the 5 day stimulation phase with a minimum time of 1h between measurements and start/end of the stimulation (day1 pre and day 5 post))

Study Sites (1)

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