The Rubber Hand Illusion (RHI) in Patients With CRPS

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Christoph Maier, Prof. Dr., Ruhr University of Bochum

ClinicalTrials.gov Identifier:

NCT01618578

First received: June 11, 2012

Last updated: June 24, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 11, 2012

Last Updated Date

June 24, 2012

Start Date ^ICMJE

May 2010

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

subjective illusion strength by a validated questionnaire [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

The illusion strength was measured subjectively by a validated questionnaire on a 7- point Likert scale,ranging from 0 (= disagree strongly) to 7 (= agree strongly). The questionnaire encompassed five slightly modified items of the German-translated questionnaire by Ocklenburg et al.(2011), following Botvinick & Cohen (1998).In the experimental conditions the questionnaire was additionally augmented by three further statements regarding the perception of the needle threat.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01618578 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

objectified illusion strength by measure of skin conductance response (SCR) [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
The SCR represents an objective measure of participant´s identification with the artificial limb, indicating the autonomic nervous system arousal in anticipation of pain, while watching the prosthesis being harmed (Armel & Ramachandran, 2003; Ehrsson, Wiech, Weiskopf, Dolan & Passingham, 2007). In every trial, the SCR was recorded with Ag-AgCl electrodes from the thenar and hypothenar eminence of the non-tested hand. Conductivity was measured in micro-Siemens (1/Ohm).
Measurement of influences of the illusion strength [ Time Frame: half an hour ] [ Designated as safety issue: No ]
Several questionnaires were used to assess current and average pain intensity (NRS 0-10), neglect-like severity symptoms (Frettloeh et al. 2006), Handedness (Oldfield,1971), body plasticity (TABP) (Desmond, Horgan et al., 2001), empathy (IRI) ( Davis, 1980) and DASH-score (German, Wind et al. 1999).

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Rubber Hand Illusion (RHI) in Patients With CRPS

Official Title ^ICMJE

Comparable Induction of the Rubber Hand Illusion (RHI) in Complex Regional Pain Syndrome Type 1 (CRPS 1) and Healthy Subjects

Brief Summary

The present study investigates by means of the rubber hand illusion body image stability and sense of body ownership in patients with CRPS of the upper limb compared to patients with unilateral pain of origin other than CRPS and age and sex-matched healthy subjects.

Detailed Description

In patients with CRPS of the upper limb distortions of body representation and impairments of sense of body ownership are well-known. To investigate the body schema and body image stability of these patients in comparison to patients with upper limb pain of origin other than CRPS and healthy subjects, we conducted a series of rubber hand illusions. This well - established paradigm is elicited by visuo-tactile stimulation of one´s own real hand and a visible hand and forearm prosthesis. The present study investigates 1) if and how far patients with CRPS are susceptible to experience the illusion 2) how far the illusion strength differs between CRPS and patients with unilateral pain of the upper limb of other origin and healthy subjects 3) how far parameters, e.g. neglect-like severity symptoms, body plasticity, empathy, duration of disease and pain intensity influence the illusion strength.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

The study sample consists of three groups:

Patients with CRPS of the upper limb type 1 ( n=24)
Patients with unilateral pain of the upper limb origin other than CRPS (n=21)
Healthy subjects, age and sex-matched to patients with CRPS Patients with unilateral pain of the upper limb of origin other than CRPS serve as controls. Recruitment for all CRPS and the majority of patients in the control group took place in the pain clinic of the Bergmannsheil University Hospital in Bochum. The remaining patients were recruited from the Neurological respectively Surgical department of the Bergmannsheil University Hospital.

Condition ^ICMJE

CRPS
Unilateral Limb Pain of Origin Other Than CRPS

Intervention ^ICMJE

Procedure: rubber hand illusion

There were three consecutive trials of the RHI:

one control trial: asynchronous condition (3 Min.)
two experimental trials (conducted on both hands):synchronous condition (3 Min.),additionally watching the prosthesis being threatened (20 sec.)

Study Group/Cohort (s)

Patients with CRPS
24 patients with CRPS of the upper limb type 1 were included into the study.

Intervention: Procedure: rubber hand illusion
Patients with unilateral upper limb pain
21 patients with unilateral upper limb pain served as controls.

Intervention: Procedure: rubber hand illusion
healthy subjects
24 healthy subjects were age- and sex matched to patients with CRPS.

Intervention: Procedure: rubber hand illusion

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2011

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

every participant:

aged > 18 years
written informed consent
free to withdraw participation at any time
adequate understanding of the german language

Patients with CRPS:

patients with CRPS type 1 of the upper limb
clinical symptoms were diagnosed on the basis of the recently modified diagnostic research criteria (Harden, Bruehl et al., 2007)
proved by typical enhancement in the late phase of the 99m-technetium-triple-phase bone skeleton scintigraphy (Wüppenhorst, Maier et al., 2010)

Patients with unilateral pain of the upper limb:

unilateral pain
pain of origin other than CRPS

Healthy subjects:

age and sex matched to patients with CRPS
checked by the DFNS IMI questionnaire

Exclusion Criteria:

every participant:

inadequate understanding of the german language
missing informed consent
diabetes mellitus

Patients with CRPS:

-CRPS Type 2

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01618578

Other Study ID Numbers ^ICMJE

RHI2010

Has Data Monitoring Committee

Responsible Party

Christoph Maier, Prof. Dr., Ruhr University of Bochum

Study Sponsor ^ICMJE

Ruhr University of Bochum

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Christoph Maier, Prof. Dr.

Head of the pain clinic of the Bergmannsheil University Hospital

Information Provided By

Ruhr University of Bochum

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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