SDRC: Body Perception and Complex Regional Pain Syndrome

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Completed
CT.gov ID
NCT02901002
Collaborator
(none)
20
1
9.7
2.1

Study Details

Study Description

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 Phase
  • 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.

Study Design

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 :
Jan 6, 2017
Actual Primary Completion Date :
Oct 27, 2017
Actual Study Completion Date :
Oct 27, 2017

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Sensory testing [day 1]

    areas of the hand where spontaneous sensations were felt

Secondary Outcome Measures

  1. Neurological evaluation by questionary [day 1]

    Score to HAD (anxiety-depression) scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Saint-Etienne Saint-Etienne France 42055

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Christelle CREAC'H, MD, CHU SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT02901002
Other Study ID Numbers:
  • 1608097
  • 2016-A01248-43
First Posted:
Sep 15, 2016
Last Update Posted:
Jan 17, 2018
Last Verified:
Nov 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 17, 2018