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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)

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ClinicalTrials.gov Identifier: NCT04703348
Recruitment Status : Completed
First Posted : January 11, 2021
Last Update Posted : November 30, 2022
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndromes Musculoskeletal Pain Disorder Healthy Diagnostic Test: Motor imagery Questionnaire - Revised Second (MIQ-RS) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3 groups with different healthcare conditions are compared in motor imagery capacities
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Pilot Study on the Assessment of Motor Imaging Skills in Patients With Complex Regional Pain Syndrome (CRPS)
Actual Study Start Date : January 12, 2021
Actual Primary Completion Date : October 16, 2022
Actual Study Completion Date : October 16, 2022

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Arms and Interventions
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Arm Intervention/treatment
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
 Diagnostic Test: Motor imagery Questionnaire - Revised Second (MIQ-RS)

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.
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
 Diagnostic Test: Motor imagery Questionnaire - Revised Second (MIQ-RS)

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.
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
 Diagnostic Test: Motor imagery Questionnaire - Revised Second (MIQ-RS)

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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04703348


Locations
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France
CHU de Nimes
Nimes, Gard, France, 30029 NIMES Cedex 9
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT04703348    
Other Study ID Numbers: LOCAL/2020/MO-01
First Posted: January 11, 2021    Key Record Dates
Last Update Posted: November 30, 2022
Last Verified: November 2022

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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 Nīmes:
complex regional pain syndromes
motor imagery
mental imagery
MIQ-RS
 Pilot study
comparison groups
CRPS
Additional relevant MeSH terms:
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Musculoskeletal Pain
Rheumatic Diseases
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Collagen Diseases
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
 Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Connective Tissue Diseases