Effects of Repetitive Electric Sensory Stimulation (RSS) as Intervention in Complex-regional-pain-syndrome Type I (CRPS)
Primary Purpose
Complex Regional Pain Syndrome Type I of the Upper Limb
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
RSS (repetitive sensory stimulation)
SHAM-RSS
Sponsored by
About this trial
This is an interventional basic science trial for Complex Regional Pain Syndrome Type I of the Upper Limb focused on measuring CRPS, repetitive sensory stimulation, cortical reorganization, 2-point-discrimination
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
Sites / Locations
- Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Verum-RSS
Sham-RSS
Arm Description
RSS Stimulation with high frequency electric pulses
Sham RSS Stimulation (no pulses are transmitted)
Outcomes
Primary Outcome Measures
static 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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01915329
Brief Title
Effects of Repetitive Electric Sensory Stimulation (RSS) as Intervention in Complex-regional-pain-syndrome Type I (CRPS)
Official Title
Effects of Repetitive Electric Sensory Stimulation on Sensorimotor Performance and Pain Intensity in Complex Regional Pain Syndrome Type I
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndrome Type I of the Upper Limb
Keywords
CRPS, repetitive sensory stimulation, cortical reorganization, 2-point-discrimination
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Verum-RSS
Arm Type
Experimental
Arm Description
RSS Stimulation with high frequency electric pulses
Arm Title
Sham-RSS
Arm Type
Sham Comparator
Arm Description
Sham RSS Stimulation (no pulses are transmitted)
Intervention Type
Device
Intervention Name(s)
RSS (repetitive sensory stimulation)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
SHAM-RSS
Intervention Description
The same device as in the RSS intervention is used, but no electrical stimuli are transmitted.
Primary Outcome Measure Information:
Title
static tactile 2-point-discrimination threshold
Description
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)
Secondary Outcome Measure Information:
Title
pain intensity
Description
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)
Other Pre-specified Outcome Measures:
Title
somatosensory evoked potentials
Description
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.
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH
City
Bochum
State/Province
NRW
ZIP/Postal Code
44789
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Maier, M.D., PhD
Phone
0049234302
Ext
6366
Email
christoph.maier@rub.de
First Name & Middle Initial & Last Name & Degree
Marianne David, Dr.
Phone
0049-234-303
Ext
3324
Email
Marianne.David@rub.de
12. IPD Sharing Statement
Learn more about this trial
Effects of Repetitive Electric Sensory Stimulation (RSS) as Intervention in Complex-regional-pain-syndrome Type I (CRPS)
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