The Rubber Hand Illusion (RHI) in Patients With CRPS

CRPS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618578
• Other study ID #: RHI2010
• Status: Completed
• Phase: N/A
• First received: June 11, 2012
• Last updated: June 24, 2012
• Start date: May 2010
• Est. completion date: November 2011

Study information

• Verified date: June 2012
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• CRPS
• Reflex Sympathetic Dystrophy
• Unilateral Limb Pain of Origin Other Than CRPS

Intervention

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.)

Locations

Country	Name	City	State
Germany	Pain clinic of the Bergmannsheil University Hospital	Bochum

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subjective illusion strength by a validated questionnaire	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	No
Secondary	objectified illusion strength by measure of skin conductance response (SCR)	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	No
Secondary	Measurement of influences of the illusion strength	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	No