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
Verified date | June 2012 |
Source | Ruhr University of Bochum |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Observational |
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.
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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Pain clinic of the Bergmannsheil University Hospital | Bochum |
Lead Sponsor | Collaborator |
---|---|
Ruhr University of Bochum |
Germany,
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 |
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