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Body Perception and Complex Regional Pain Syndrome (SDRC)

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ClinicalTrials.gov Identifier: NCT02901002
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Tracking Information
First Submitted Date September 5, 2016
First Posted Date September 15, 2016
Last Update Posted Date January 17, 2018
Actual Study Start Date January 6, 2017
Actual Primary Completion Date October 27, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 9, 2016)
Sensory testing [ Time Frame: day 1 ]
areas of the hand where spontaneous sensations were felt
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02901002 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 9, 2016)
Neurological evaluation by questionary [ Time Frame: day 1 ]
Score to HAD (anxiety-depression) scale
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Body Perception and Complex Regional Pain Syndrome
Official Title Body Perception and Complex Regional Pain Syndrome : a Case-control Study
Brief Summary

In CRPS, perturbation of body image and pseudo-neglect syndrome of the body part affected are frequently found. Pain and sensory perturbation seems to modify the way patients perceived their body part affected.

Does a local body image perturbation can affect the balanced of the global self-awareness?

Detailed Description With the investigation of spontaneous sensations (SPS) according to the protocol of Michael and al (2011) the investigators study how patients can listen to their internal sensations located in other body part than the painful member in order to construct a representation of the body and maintain it in active consciousness. A group of controls will be included to understand if there is a global modification in the perception of SPS witch may be linked to the pathology.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients suffering from CRPS of the lower limb and Healthy controls
Condition Complex Regional Pain Syndromes
Intervention
  • Other: Sensory testing in the two hand
    spontaneous sensations while watching a hand
  • Other: Neuropsychological evaluation
    Score to anxiety-depression scale
Study Groups/Cohorts
  • Patient
    Patients suffering from CRPS of the lower limb Patients with sensory testing in the two hand and neuropsychological evaluation
    Interventions:
    • Other: Sensory testing in the two hand
    • Other: Neuropsychological evaluation
  • Control
    Healthy controls match by age, gender, Body Mass Index Healthy volunteers with sensory testing in the two hand and neuropsychological evaluation
    Interventions:
    • Other: Sensory testing in the two hand
    • Other: Neuropsychological evaluation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 16, 2018)
20
Original Estimated Enrollment
 (submitted: September 9, 2016)
24
Actual Study Completion Date October 27, 2017
Actual Primary Completion Date October 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • For patients:

    • a diagnosis of CRPS of the lower limb according to the Budapest Criteria (men or women) For patients and control group

  • Age ≥ 18 years

Exclusion Criteria:

For patients and control group

  • neurological disease with cerebral repercussion or not stabilized serious physical illness;
  • psychotropic medication
  • disorders related to the use of a psychoactive substance (abuse, dependence or withdrawal);

    • For patients:
  • Presence of an other pain disorder
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02901002
Other Study ID Numbers 1608097
2016-A01248-43 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor Centre Hospitalier Universitaire de Saint Etienne
Collaborators Not Provided
Investigators
Principal Investigator: Christelle CREAC'H, MD CHU SAINT-ETIENNE
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date November 2017