NCT01618578

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
Last Updated

June 26, 2012

Status Verified

June 1, 2012

Enrollment Period

1.5 years

First QC Date

June 11, 2012

Last Update Submit

June 24, 2012

Conditions

Keywords

rubber hand illusionCRPSbody imagebody ownership

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • objectified illusion strength by measure of skin conductance response (SCR)

    1 hour

  • Measurement of influences of the illusion strength

    half an hour

Study Arms (3)

Patients with CRPS

24 patients with CRPS of the upper limb type 1 were included into the study.

Procedure: rubber hand illusion

Patients with unilateral upper limb pain

21 patients with unilateral upper limb pain served as controls.

Procedure: rubber hand illusion

healthy subjects

24 healthy subjects were age- and sex matched to patients with CRPS.

Procedure: rubber hand illusion

Interventions

There 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.)

Patients with CRPSPatients with unilateral upper limb painhealthy subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • every participant:
  • inadequate understanding of the german language
  • missing informed consent
  • diabetes mellitus
  • Patients with CRPS:
  • CRPS Type 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain clinic of the Bergmannsheil University Hospital

Bochum, 44789, Germany

Location

Study Officials

  • Christoph Maier, Prof. Dr.

    Head of the pain clinic of the Bergmannsheil University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. (Head of the pain clinic of the Bergmannsheil University Hospital)

Study Record Dates

First Submitted

June 11, 2012

First Posted

June 13, 2012

Study Start

May 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

June 26, 2012

Record last verified: 2012-06

Locations