The Complex Regional Pain Syndrome (CRPS) is a Chronic Pain Condition. This is a Preliminary Study to Explore and Test Clinical Hypothesis. They Suppose That CRPS Patients Have Impairment in Their Mental or Motor Imagery Abilities. (ImagNimes)

November 29, 2022 updated by: Centre Hospitalier Universitaire de Nīmes

Pilot Study on the Assessment of Motor Imaging Skills in Patients With Complex Regional Pain Syndrome (CRPS)

Medical functional imagery seems to demonstrate that patients suffering from complex regional pain syndrome (CRPS) have cortical modifications that alter their motor (or mental) imagery capacities. Nowadays, the use of motor imagery exercises are used in conventional rehabilitation treatments. But, in clinical practice, no study has verified if patients with CRPS desmonstrate problems in their motor imagery capacities. The MIQ-RS (Motor Imagery Questionnaire - Revised Second) is a valid, reliable and translated into French questionnaire to measure patients' capacities to do mental imagery. In this study, we compare 3 groups of 50 patients : healthy patients, patients with CRPS and patients with musculoskeletal disorder without CRPS. Every patient will take the MIQ-RS for the right and left body side. We hypothesis that patients with CRPS have more deficit than the 2 others to realise motor imagery.

Study Overview

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Not Applicable

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

    • Gard
      • Nimes, Gard, France, 30029 NIMES Cedex 9
        • CHU de Nimes

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with French healthcare affiliation
  • Adult patient (> 18 years old)
  • Patient with bachelor degree minimum
  • Patient practicing less than 150 minutes of moderate to intense physical activity per week

Specific Inclusion Criteria for CRPS group :

  • Patient followed in the Evaluation and Treatment pain center (University Hospital of Nimes)
  • Patient with secondary CRPS due to a traumatism or a surgery

Specific Inclusion Criteria for Musculoskeletal group :

  • Patient with musculoskelettal disorder on a limb (upper or lower)
  • Patient followed in the University Hospital of Nimes

Non inclusion Criteria :

  • Patient who participates in another category 1 research
  • Patient in a exclusion period in another study
  • Patient under legal protection, under guardianship or under curatorship
  • Patient for whom it is impossible to give clear information.
  • Pregnant, parturient or breastfeeding patient.
  • Patient with amputation on one of his limb
  • Patient with visual cecity
  • Patient who has already practiced mental imagery
  • Patient with neurological impairment
  • Patient with chronic low back pain and fibromyalgia

Specific non inclusion criteria for Musculoskeletal group and healthy group :

-Patient with CRPS

Specific non inclusion Criteria for CRPS group :

  • Secondary CRPS to CVA (cerebrovascular accident)
  • Patient receiving lymph node block treatment between the inclusion visit and the follow-up visit

Specific non inclusion Criteria for Musculoskeletal Disorder group :

  • Patient with secondary musculoskeletal disorder to a CVA

Exclusion criteria :

  • Questionnaire MIQ-RS not completed or non respect with the research protocol
  • pathology discovered incompatible with the study criteria

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

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Healthy patients
Healthy patients take the MIQ-RS during about 40 minutes : about 20 minutes for the assessment of the right side and about 20 minutes for the left side

Patients fulfill a questionnaire measuring individuals capacities to realize mental imagery. For more facilities and less risk of bias, the MIQ-RS was written on an online version with questions recorded in audio format. No official cut-off exists but studies seem to prove that people with :

  • a score less than 48/98 are unable to do motor imagery
  • a score between 49 and 73/98 have disturbed motor imagery capacities
  • a score more than 74/98 have normal motor imagery capacities.
Other: Complex regional pain syndrome patients
Complex regional pain syndrome patients take the MIQ-RS during about 40 minutes : about 20 minutes for the assessment of the right side and about 20 minutes for the left side

Patients fulfill a questionnaire measuring individuals capacities to realize mental imagery. For more facilities and less risk of bias, the MIQ-RS was written on an online version with questions recorded in audio format. No official cut-off exists but studies seem to prove that people with :

  • a score less than 48/98 are unable to do motor imagery
  • a score between 49 and 73/98 have disturbed motor imagery capacities
  • a score more than 74/98 have normal motor imagery capacities.
Other: Musculoskelettal disorders patients
Musculoskelettal disorders patients take the MIQ-RS during about 40 minutes : about 20 minutes for the assessment of the right side and about 20 minutes for the left side

Patients fulfill a questionnaire measuring individuals capacities to realize mental imagery. For more facilities and less risk of bias, the MIQ-RS was written on an online version with questions recorded in audio format. No official cut-off exists but studies seem to prove that people with :

  • a score less than 48/98 are unable to do motor imagery
  • a score between 49 and 73/98 have disturbed motor imagery capacities
  • a score more than 74/98 have normal motor imagery capacities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor imagery capacities on the affected side for CRPS group and musculoskelettal disorder group.
Time Frame: Day 1

Taking the MIQ-RS for 1 side, during about 20 minutes The questionnaire includes 14 questions : 7 for kinesthesic motor imagery and 7 for visual motor imagery For less bias, the questionnaire was recorded in audio for each of the 14 questions on an online assessment.

No official cut-off exists but studies seem to prove that people with :

  • a score less than 48/98 are unable to do motor imagery
  • a score between 49 and 73/98 have disturbed motor imagery capacities
  • a score more than 74/98 have normal motor imagery capacities.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor imagery capacities between affected side and unaffected side
Time Frame: Day 1

Taking the MIQ-RS for 1 side, during about 20 minutes The questionnaire includes 14 questions : 7 for kinesthesic motor imagery and 7 for visual motor imagery For less bias, the questionnaire was recorded in audio for each of the 14 questions on an online assessment.

No official cut-off exists but studies seem to prove that people with :

  • a score less than 48/98 are unable to do motor imagery
  • a score between 49 and 73/98 have disturbed motor imagery capacities
  • a score more than 74/98 have normal motor imagery capacities.
Day 1

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 12, 2021

Primary Completion (Actual)

October 16, 2022

Study Completion (Actual)

October 16, 2022

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

January 7, 2021

First Posted (Actual)

January 11, 2021

Study Record Updates

Last Update Posted (Actual)

November 30, 2022

Last Update Submitted That Met QC Criteria

November 29, 2022

Last Verified

November 1, 2022

More Information

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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