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
  Purpose

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.


Condition Intervention
CRPS
Unilateral Limb Pain of Origin Other Than CRPS
Procedure: rubber hand illusion

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparable Induction of the Rubber Hand Illusion (RHI) in Complex Regional Pain Syndrome Type 1 (CRPS 1) and Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 69
Study Start Date: May 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with CRPS
24 patients with CRPS of the upper limb type 1 were included into the study.
Procedure: rubber hand illusion

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.
Procedure: rubber hand illusion

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.
Procedure: rubber hand illusion

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.)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618578

Locations
Germany
Pain clinic of the Bergmannsheil University Hospital
Bochum, Germany, 44789
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Study Director: Christoph Maier, Prof. Dr. Head of the pain clinic of the Bergmannsheil University Hospital
  More Information

No publications provided

Responsible Party: Christoph Maier, Prof. Dr., Prof. Dr. med. (Head of the pain clinic of the Bergmannsheil University Hospital), Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01618578     History of Changes
Other Study ID Numbers: RHI2010
Study First Received: June 11, 2012
Last Updated: June 24, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Ruhr University of Bochum:
rubber hand illusion
CRPS
body image
body ownership

Additional relevant MeSH terms:
Illusions
Complex Regional Pain Syndromes
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Autonomic Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on July 22, 2014