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

Not Applicable

• Conditions: Complex Regional Pain Syndrome Type I of the Upper Limb
• Interventions: Device: RSS (repetitive sensory stimulation); Device: SHAM-RSS

• Registration Number: NCT01915329
• Lead Sponsor: Ruhr University of Bochum

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-05-13
• Status Verified: 2013-06
• Study First Submitted QC: 2013-07-31
• Last Update Submitted: 2013-07-31
• Study First Posted: 2013-08-02
• Last Update Posted: 2013-08-02
• Primary Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum-RSS	RSS (repetitive sensory stimulation)	RSS Stimulation with high frequency electric pulses
Sham-RSS	SHAM-RSS	Sham RSS Stimulation (no pulses are transmitted)

Primary Outcome Measures

Name	Time	Method
static tactile 2-point-discrimination threshold	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

Name	Time	Method
pain intensity	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.

Trial Locations

Locations (1)

Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH; 🇩🇪 Bochum, NRW, Germany