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.
A specific high frequency electric stimulation is conveyed at 5 days to the affected hand. Each stimulation session lasts 45 minutes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
50
RSS is a high frequency electrical stimulation protocol delivered to the peripheral nerves (median and ulnar nerve) of the hand. The signals are generated by a TENS-stimulator and are conveyed to each finger of the hand via a custom-made hand-shaped device with conductive contacts at each fingertip and at the palmar base. In case of the sham-stimulation no pulses are transmitted.
The same device as in the RSS intervention is used, but no electrical stimuli are transmitted.
Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH
Bochum, North Rhine-Westphalia, Germany
RECRUITINGstatic tactile 2-point-discrimination threshold
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.
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)
pain intensity
Pain intensity is rated by the patient on a 11-point numerical rating scale (NRS). Pain intensity is rated before the start of the 5 day stimulation phase (baseline,pre) and at the end (post, in combination with the other outcome measures). Additionally pain intensity is rated directly before the start of each daily stimulation session and immediately after each session of 45 minute duration.
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)
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