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

July 31, 2013 updated by: Christoph Maier, Prof. Dr., Ruhr University of Bochum

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Bochum, NRW, Germany, 44789
        • Recruiting
        • Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruhr University of Bochum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

July 31, 2013

First Posted (Estimate)

August 2, 2013

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

July 31, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSS_2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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