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The Rubber Hand Illusion (RHI) in Patients With CRPS

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ClinicalTrials.gov Identifier: NCT01618578
Recruitment Status : Completed
First Posted : June 13, 2012
Last Update Posted : June 26, 2012
Sponsor:
Information provided by (Responsible Party):
Christoph Maier, Prof. Dr., Ruhr University of Bochum

Tracking Information
First Submitted Date June 11, 2012
First Posted Date June 13, 2012
Last Update Posted Date June 26, 2012
Study Start Date May 2010
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 12, 2012)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01618578 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 12, 2012)
  • 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).
  • 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Rubber Hand Illusion (RHI) in Patients With CRPS
Official Title 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 Observational
Study Design 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:

  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.
Condition
  • CRPS
  • Unilateral Limb Pain of Origin Other Than CRPS
Intervention 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.)
Study Groups/Cohorts
  • 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 Completed
Actual Enrollment
 (submitted: June 12, 2012)
69
Original Actual Enrollment Same as current
Actual Study Completion Date November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01618578
Other Study ID Numbers RHI2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Christoph Maier, Prof. Dr., Ruhr University of Bochum
Study Sponsor Ruhr University of Bochum
Collaborators Not Provided
Investigators
Study Director: Christoph Maier, Prof. Dr. Head of the pain clinic of the Bergmannsheil University Hospital
PRS Account Ruhr University of Bochum
Verification Date June 2012