NCT02901002

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

January 6, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2017

Completed
Last Updated

January 17, 2018

Status Verified

November 1, 2017

Enrollment Period

10 months

First QC Date

September 5, 2016

Last Update Submit

January 16, 2018

Conditions

Keywords

Complex Regional Pain SyndromesPainSpontaneous sensationsinteroception

Outcome Measures

Primary Outcomes (1)

  • Sensory testing

    areas of the hand where spontaneous sensations were felt

    day 1

Secondary Outcomes (1)

  • Neurological evaluation by questionary

    day 1

Study Arms (2)

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 handOther: Neuropsychological evaluation

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 handOther: Neuropsychological evaluation

Interventions

spontaneous sensations while watching a hand

ControlPatient

Score to anxiety-depression scale

ControlPatient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients suffering from CRPS of the lower limb and Healthy controls

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Complex Regional Pain SyndromesPain

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christelle CREAC'H, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2016

First Posted

September 15, 2016

Study Start

January 6, 2017

Primary Completion

October 27, 2017

Study Completion

October 27, 2017

Last Updated

January 17, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations