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Effects of Repetitive Electric Sensory Stimulation (RSS) as Intervention in Complex-regional-pain-syndrome Type I (CRPS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by Christoph Maier, Prof. Dr., Ruhr University of Bochum.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Christoph Maier, Prof. Dr., Ruhr University of Bochum Identifier:
First received: May 13, 2013
Last updated: July 31, 2013
Last verified: June 2013
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.

Condition Intervention
Complex Regional Pain Syndrome Type I of the Upper Limb
Device: RSS (repetitive sensory stimulation)
Device: SHAM-RSS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Repetitive Electric Sensory Stimulation on Sensorimotor Performance and Pain Intensity in Complex Regional Pain Syndrome Type I

Resource links provided by NLM:

Further study details as provided by Christoph Maier, Prof. Dr., Ruhr University of Bochum:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • pain intensity [ 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 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.

Other Outcome Measures:
  • somatosensory evoked potentials [ 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) ]
    Somatosensory evoked potentials after electrical paired pulse median nerve stimulation are recorded. The median nerve is stimulated by innocuous paired electrical pulses conveyed to the nerve by a block electrode placed on the wrist. For correct positioning the subject has to report a prickling sensation in thumb, index and middle finger. Stimulation intensity is choosen to induce a small muscular twich at the thenar muscles. SEP recordings are done with a 3-electrode array. Two electrodes are fixed on the scalp over the left and right somatosensory cortex. The third (reference) electrode is fixed over the midfront. SEP signals get amplified and filtered and digitized in a PC.

Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Verum-RSS
RSS Stimulation with high frequency electric pulses
Device: RSS (repetitive sensory stimulation)

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.

Sham Comparator: Sham-RSS
Sham RSS Stimulation (no pulses are transmitted)
Device: SHAM-RSS
The same device as in the RSS intervention is used, but no electrical stimuli are transmitted.

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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01915329

Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH Recruiting
Bochum, NRW, Germany, 44789
Contact: Christoph Maier, M.D., PhD    0049234302 ext 6366   
Contact: Marianne David, Dr.    0049-234-303 ext 3324   
Sponsors and Collaborators
Ruhr University of Bochum
  More Information

Responsible Party: Christoph Maier, Prof. Dr., Prof. Dr. med Christoph Maier, Head Dep. of Pain Medicine, Ruhr University of Bochum Identifier: NCT01915329     History of Changes
Other Study ID Numbers: RSS_2012
Study First Received: May 13, 2013
Last Updated: July 31, 2013

Keywords provided by Christoph Maier, Prof. Dr., Ruhr University of Bochum:
repetitive sensory stimulation
cortical reorganization

Additional relevant MeSH terms:
Somatoform Disorders
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Pathologic Processes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases processed this record on May 25, 2017