- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01618578
The Rubber Hand Illusion (RHI) in Patients With CRPS
June 24, 2012 updated by: Christoph Maier, Prof. Dr., Ruhr University of Bochum
Comparable Induction of the Rubber Hand Illusion (RHI) in Complex Regional Pain Syndrome Type 1 (CRPS 1) and Healthy Subjects
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.
Study Overview
Status
Completed
Intervention / Treatment
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
Enrollment (Actual)
69
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bochum, Germany, 44789
- Pain clinic of the Bergmannsheil University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study sample consists of three groups:
- Patients with CRPS of the upper limb type 1 ( n=24)
- Patients with unilateral pain of the upper limb origin other than CRPS (n=21)
- 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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with CRPS
24 patients with CRPS of the upper limb type 1 were included into the study.
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There were three consecutive trials of the RHI:
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Patients with unilateral upper limb pain
21 patients with unilateral upper limb pain served as controls.
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There were three consecutive trials of the RHI:
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healthy subjects
24 healthy subjects were age- and sex matched to patients with CRPS.
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There were three consecutive trials of the RHI:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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1 hour
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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).
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1 hour
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Measurement of influences of the illusion strength
Time Frame: half an hour
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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).
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half an hour
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (ACTUAL)
November 1, 2011
Study Completion (ACTUAL)
November 1, 2011
Study Registration Dates
First Submitted
June 11, 2012
First Submitted That Met QC Criteria
June 12, 2012
First Posted (ESTIMATE)
June 13, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
June 26, 2012
Last Update Submitted That Met QC Criteria
June 24, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHI2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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