- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04703348
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)
Pilot Study on the Assessment of Motor Imaging Skills in Patients With Complex Regional Pain Syndrome (CRPS)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gard
-
Nîmes, Gard, France, 30029 NIMES Cedex 9
- CHU de Nîmes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 :
|
|
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 :
|
|
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 :
|
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 :
|
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 :
|
Day 1
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LOCAL/2020/MO-01
- 2020-A02281-38 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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