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

NCT ID: NCT01915329

Last Updated: 2013-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Brief Summary

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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

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

Conditions

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Complex Regional Pain Syndrome Type I of the Upper Limb

Keywords

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CRPS repetitive sensory stimulation cortical reorganization 2-point-discrimination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Verum-RSS

RSS Stimulation with high frequency electric pulses

Group Type EXPERIMENTAL

RSS (repetitive sensory stimulation)

Intervention Type DEVICE

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-RSS

Sham RSS Stimulation (no pulses are transmitted)

Group Type SHAM_COMPARATOR

SHAM-RSS

Intervention Type DEVICE

The same device as in the RSS intervention is used, but no electrical stimuli are transmitted.

Interventions

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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.

Intervention Type DEVICE

SHAM-RSS

The same device as in the RSS intervention is used, but no electrical stimuli are transmitted.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Christoph Maier, Prof. Dr.

Prof. Dr. med Christoph Maier, Head Dep. of Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH

Bochum, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Christoph Maier, M.D., PhD

Role: primary

Marianne David, Dr.

Role: backup

Other Identifiers

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RSS_2012

Identifier Type: -

Identifier Source: org_study_id