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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Ruhr University of Bochum
Sponsor:
Information provided by (Responsible Party):
Christoph Maier, Prof. Dr., Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01915329
First received: May 13, 2013
Last updated: July 31, 2013
Last verified: June 2013
  Purpose

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
Endpoint Classification: Efficacy Study
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 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01915329

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

No publications provided

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

Keywords provided by Ruhr University of Bochum:
CRPS
repetitive sensory stimulation
cortical reorganization
2-point-discrimination

Additional relevant MeSH terms:
Reflex Sympathetic Dystrophy
Somatoform Disorders
Complex Regional Pain Syndromes
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014