CRPSNCT01618578
The Rubber Hand Illusion (RHI) in Patients With CRPS
An observational study of CRPS and Unilateral Limb Pain of Origin Other Than CRPS, run by Ruhr University of Bochum at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- CRPS, Unilateral Limb Pain of Origin Other Than CRPS
- What is being tested?
- rubber hand illusion
- Type of treatment
- Surgery or procedure
- How many people
- 69 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- every participant:
- aged > 18 years
- written informed consent
- free to withdraw participation at any time
- adequate understanding of the german language
- Patients with CRPS:
Show all 15Show fewer
- 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
Who cannot join
- every participant:
- inadequate understanding of the german language
- missing informed consent
- diabetes mellitus
- Patients with CRPS:
- -CRPS Type 2
Trial locations and contacts
1 site in 1 country.
Germany1 site
Pain clinic of the Bergmannsheil University Hospital
Bochum, 44789
About this study
Official title: 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.
Read the 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.
- Being tested
- rubber hand illusion
- Keywords
- rubber hand illusion, CRPS, body image, body ownership
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rubber hand illusionProcedure or surgery
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.)
| Study group | Role | What they receive |
|---|---|---|
| Patients with CRPS | 24 patients with CRPS of the upper limb type 1 were included into the study. Receives: Procedure: rubber hand illusion | |
| Patients with unilateral upper limb pain | 21 patients with unilateral upper limb pain served as controls. Receives: Procedure: rubber hand illusion | |
| healthy subjects | 24 healthy subjects were age- and sex matched to patients with CRPS. Receives: Procedure: rubber hand illusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (2)
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).
Measured: 1 hour
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).
Measured: half an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startMay 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRPSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Maier, Prof. Dr., Ruhr University of Bochum
- Investigators
- Christoph Maier, Prof. Dr., Study director, Head of the pain clinic of the Bergmannsheil University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618578
- Sponsor's protocol ID
- RHI2010
- Status last verified
- Jun 2012
- First submitted
- 11 Jun 2012
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparable Induction of the Rubber Hand Illusion (RHI) in Complex Regional Pain Syndrome Type 1 (CRPS 1) and Healthy Subjects
- ClinicalTrials.gov ID
- NCT01618578
- Acronym / sponsor ID
- RHI2010
- Keywords
- rubber hand illusion, CRPS, body image, body ownership
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 13 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with CRPS | – | Procedure: rubber hand illusion24 patients with CRPS of the upper limb type 1 were included into the study. |
| Patients with unilateral upper limb pain | – | Procedure: rubber hand illusion21 patients with unilateral upper limb pain served as controls. |
| healthy subjects | – | Procedure: rubber hand illusion24 healthy subjects were age- and sex matched to patients with CRPS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- aged > 18 years
- written informed consent
- free to withdraw participation at any time
- adequate understanding of the german language
- patients with CRPS type 1 of the upper limb
Key exclusion criteria (6 listed)
- inadequate understanding of the german language
- missing informed consent
- diabetes mellitus
- -CRPS Type 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rubber hand illusionThere 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.) | Procedure or surgery | Patients with CRPS, Patients with unilateral upper limb pain, healthy subjects |
Primary outcome
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.
2 secondary outcomes
objectified illusion strength by measure of skin conductance response (SCR)
Time frame: 1 hour
Measurement of influences of the illusion strength
Time frame: half an hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Maier, Prof. Dr. study director
Head of the pain clinic of the Bergmannsheil University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CRPS and Unilateral Limb Pain of Origin Other Than CRPS, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subjective illusion strength by a validated questionnaire (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2012.