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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)

Primary Purpose

Complex Regional Pain Syndromes, Musculoskeletal Pain Disorder, Healthy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Motor imagery Questionnaire - Revised Second (MIQ-RS)
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Complex Regional Pain Syndromes focused on measuring complex regional pain syndromes, motor imagery, mental imagery, MIQ-RS, Pilot study, comparison groups, CRPS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Nimes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Healthy patients

Complex regional pain syndrome patients

Musculoskelettal disorders patients

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Motor imagery capacities on the affected side for CRPS group and musculoskelettal disorder group.
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

Motor imagery capacities between affected side and unaffected side
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.

Full Information

First Posted
January 7, 2021
Last Updated
November 29, 2022
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT04703348
Brief Title
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.
Acronym
ImagNimes
Official Title
Pilot Study on the Assessment of Motor Imaging Skills in Patients With Complex Regional Pain Syndrome (CRPS)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
October 16, 2022 (Actual)
Study Completion Date
October 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndromes, Musculoskeletal Pain Disorder, Healthy
Keywords
complex regional pain syndromes, motor imagery, mental imagery, MIQ-RS, Pilot study, comparison groups, CRPS

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 groups with different healthcare conditions are compared in motor imagery capacities
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy patients
Arm Type
Other
Arm Description
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
Arm Title
Complex regional pain syndrome patients
Arm Type
Other
Arm Description
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
Arm Title
Musculoskelettal disorders patients
Arm Type
Other
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Motor imagery Questionnaire - Revised Second (MIQ-RS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Motor imagery capacities on the affected side for CRPS group and musculoskelettal disorder group.
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Motor imagery capacities between affected side and unaffected side
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
CHU de Nimes
City
Nimes
State/Province
Gard
ZIP/Postal Code
30029 NIMES Cedex 9
Country
France

12. IPD Sharing Statement

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https://link.springer.com/article/10.1007/s11724-014-0368-x
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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.

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