The Rubber Hand Illusion (RHI) in Patients With CRPS

June 24, 2012 updated by: Christoph Maier, Prof. Dr., Ruhr University of Bochum

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

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.

Study Overview

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

Observational

Enrollment (Actual)

69

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

      • Bochum, Germany, 44789
        • Pain clinic of the Bergmannsheil University Hospital

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study sample consists of three groups:

  1. Patients with CRPS of the upper limb type 1 ( n=24)
  2. Patients with unilateral pain of the upper limb origin other than CRPS (n=21)
  3. 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.

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with CRPS
24 patients with CRPS of the upper limb type 1 were included into the study.

There were three consecutive trials of the RHI:

  1. one control trial: asynchronous condition (3 Min.)
  2. two experimental trials (conducted on both hands):synchronous condition (3 Min.),additionally watching the prosthesis being threatened (20 sec.)
Patients with unilateral upper limb pain
21 patients with unilateral upper limb pain served as controls.

There were three consecutive trials of the RHI:

  1. one control trial: asynchronous condition (3 Min.)
  2. two experimental trials (conducted on both hands):synchronous condition (3 Min.),additionally watching the prosthesis being threatened (20 sec.)
healthy subjects
24 healthy subjects were age- and sex matched to patients with CRPS.

There were three consecutive trials of the RHI:

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subjective illusion strength by a validated questionnaire
Time Frame: 1 hour
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.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objectified illusion strength by measure of skin conductance response (SCR)
Time Frame: 1 hour
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).
1 hour
Measurement of influences of the illusion strength
Time Frame: half an hour
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).
half an hour

Collaborators and Investigators

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

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

May 1, 2010

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

June 11, 2012

First Submitted That Met QC Criteria

June 12, 2012

First Posted (ESTIMATE)

June 13, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 26, 2012

Last Update Submitted That Met QC Criteria

June 24, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

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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