Body Perception and Complex Regional Pain Syndrome (SDRC)

January 16, 2018 updated by: Centre Hospitalier Universitaire de Saint Etienne

Body Perception and Complex Regional Pain Syndrome : a Case-control Study

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Etienne, France, 42055
        • CHU Saint-etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients suffering from CRPS of the lower limb and Healthy controls

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory testing
Time Frame: day 1
areas of the hand where spontaneous sensations were felt
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological evaluation by questionary
Time Frame: day 1
Score to HAD (anxiety-depression) scale
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Christelle CREAC'H, MD, CHU Saint-etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2017

Primary Completion (Actual)

October 27, 2017

Study Completion (Actual)

October 27, 2017

Study Registration Dates

First Submitted

September 5, 2016

First Submitted That Met QC Criteria

September 9, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1608097
  • 2016-A01248-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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