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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

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?


Condition or disease Intervention/treatment
Complex Regional Pain Syndromes Other: Sensory testing in the two hand Other: Neuropsychological evaluation

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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Body Perception and Complex Regional Pain Syndrome : a Case-control Study
Actual Study Start Date : January 6, 2017
Actual Primary Completion Date : October 27, 2017
Actual Study Completion Date : October 27, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patient
Patients suffering from CRPS of the lower limb Patients with sensory testing in the two hand and neuropsychological evaluation
Other: Sensory testing in the two hand
spontaneous sensations while watching a hand

Other: Neuropsychological evaluation
Score to anxiety-depression scale

Control
Healthy controls match by age, gender, Body Mass Index Healthy volunteers with sensory testing in the two hand and neuropsychological evaluation
Other: Sensory testing in the two hand
spontaneous sensations while watching a hand

Other: Neuropsychological evaluation
Score to anxiety-depression scale




Primary Outcome Measures :
  1. Sensory testing [ Time Frame: day 1 ]
    areas of the hand where spontaneous sensations were felt


Secondary Outcome Measures :
  1. Neurological evaluation by questionary [ Time Frame: day 1 ]
    Score to HAD (anxiety-depression) scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients suffering from CRPS of the lower limb and Healthy controls
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901002


Locations
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France
CHU Saint-Etienne
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Christelle CREAC'H, MD CHU SAINT-ETIENNE

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02901002     History of Changes
Other Study ID Numbers: 1608097
2016-A01248-43 ( Other Identifier: ANSM )
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Complex Regional Pain Syndromes
Pain
Spontaneous sensations
interoception

Additional relevant MeSH terms:
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Syndrome
Somatoform Disorders
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Disease
Pathologic Processes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases