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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04703348
Other study ID # LOCAL/2020/MO-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 12, 2021
Est. completion date October 16, 2022

Study information

Verified date November 2022
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 129
Est. completion date October 16, 2022
Est. primary completion date October 16, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
France CHU de Nimes Nimes Gard

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

References & Publications (44)

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Butler AJ, Cazeaux J, Fidler A, Jansen J, Lefkove N, Gregg M, Hall C, Easley KA, Shenvi N, Wolf SL. The Movement Imagery Questionnaire-Revised, Second Edition (MIQ-RS) Is a Reliable and Valid Tool for Evaluating Motor Imagery in Stroke Populations. Evid Based Complement Alternat Med. 2012;2012:497289. doi: 10.1155/2012/497289. Epub 2012 Feb 28. — View Citation

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Harden NR, Bruehl S, Perez RSGM, Birklein F, Marinus J, Maihofner C, Lubenow T, Buvanendran A, Mackey S, Graciosa J, Mogilevski M, Ramsden C, Schlereth T, Chont M, Vatine JJ. Development of a severity score for CRPS. Pain. 2010 Dec;151(3):870-876. doi: 10.1016/j.pain.2010.09.031. Epub 2010 Oct 20. — View Citation

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Harris JE, Hebert A. Utilization of motor imagery in upper limb rehabilitation: a systematic scoping review. Clin Rehabil. 2015 Nov;29(11):1092-107. doi: 10.1177/0269215514566248. Epub 2015 Jan 20. Review. — View Citation

Loison B, Moussaddaq AS, Cormier J, Richard I, Ferrapie AL, Ramond A, Dinomais M. Translation and validation of the French Movement Imagery Questionnaire - Revised Second Version (MIQ-RS). Ann Phys Rehabil Med. 2013 Apr;56(3):157-73. doi: 10.1016/j.rehab.2013.01.001. Epub 2013 Jan 29. — View Citation

Lorey B, Pilgramm S, Bischoff M, Stark R, Vaitl D, Kindermann S, Munzert J, Zentgraf K. Activation of the parieto-premotor network is associated with vivid motor imagery--a parametric FMRI study. PLoS One. 2011;6(5):e20368. doi: 10.1371/journal.pone.0020368. Epub 2011 May 31. — View Citation

Maihöfner C, Baron R, DeCol R, Binder A, Birklein F, Deuschl G, Handwerker HO, Schattschneider J. The motor system shows adaptive changes in complex regional pain syndrome. Brain. 2007 Oct;130(Pt 10):2671-87. Epub 2007 Jun 15. — View Citation

Maihofner C, Forster C, Birklein F, Neundorfer B, Handwerker HO. Brain processing during mechanical hyperalgesia in complex regional pain syndrome: a functional MRI study. Pain. 2005 Mar;114(1-2):93-103. doi: 10.1016/j.pain.2004.12.001. Epub 2005 Jan 26. — View Citation

Maihofner C, Handwerker HO, Neundorfer B, Birklein F. Patterns of cortical reorganization in complex regional pain syndrome. Neurology. 2003 Dec 23;61(12):1707-15. doi: 10.1212/01.wnl.0000098939.02752.8e. — View Citation

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Marinus J, Moseley GL, Birklein F, Baron R, Maihofner C, Kingery WS, van Hilten JJ. Clinical features and pathophysiology of complex regional pain syndrome. Lancet Neurol. 2011 Jul;10(7):637-48. doi: 10.1016/S1474-4422(11)70106-5. — View Citation

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* Note: There are 44 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Day 1
Secondary 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.
Day 1
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