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NCT Number: NCT01618578

The Rubber Hand Illusion (RHI) in Patients With CRPS

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.

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Key information

Conditions

CRPS Unilateral Limb Pain of Origin Other Than CRPS

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pain clinic of the Bergmannsheil University Hospital

Bochum, 44789, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rubber hand illusion

Procedure

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.)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 13, 2012
Registry last updated
Jun 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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