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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02901002
Other study ID # 1608097
Secondary ID 2016-A01248-43
Status Completed
Phase N/A
First received September 5, 2016
Last updated January 16, 2018
Start date January 6, 2017
Est. completion date October 27, 2017

Study information

Verified date November 2017
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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?


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 27, 2017
Est. primary completion date October 27, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Sensory testing in the two hand
spontaneous sensations while watching a hand
Neuropsychological evaluation
Score to anxiety-depression scale

Locations

Country Name City State
France CHU Saint-Etienne Saint-Etienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensory testing areas of the hand where spontaneous sensations were felt day 1
Secondary Neurological evaluation by questionary Score to HAD (anxiety-depression) scale day 1
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