- 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
-
Nimes, Gard, France, 30029 NIMES Cedex 9
- CHU de Nimes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
General Publications
- Sullivan MJ, Thorn B, Haythornthwaite JA, Keefe F, Martin M, Bradley LA, Lefebvre JC. Theoretical perspectives on the relation between catastrophizing and pain. Clin J Pain. 2001 Mar;17(1):52-64. doi: 10.1097/00002508-200103000-00008.
- 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.
- Birklein F, O'Neill D, Schlereth T. Complex regional pain syndrome: An optimistic perspective. Neurology. 2015 Jan 6;84(1):89-96. doi: 10.1212/WNL.0000000000001095. Epub 2014 Dec 3. Review.
- Cacchio A, De Blasis E, De Blasis V, Santilli V, Spacca G. Mirror therapy in complex regional pain syndrome type 1 of the upper limb in stroke patients. Neurorehabil Neural Repair. 2009 Oct;23(8):792-9. doi: 10.1177/1545968309335977. Epub 2009 May 22.
- McCabe CS, Haigh RC, Ring EF, Halligan PW, Wall PD, Blake DR. A controlled pilot study of the utility of mirror visual feedback in the treatment of complex regional pain syndrome (type 1). Rheumatology (Oxford). 2003 Jan;42(1):97-101. doi: 10.1093/rheumatology/keg041.
- Pervane Vural S, Nakipoglu Yuzer GF, Sezgin Ozcan D, Demir Ozbudak S, Ozgirgin N. Effects of Mirror Therapy in Stroke Patients With Complex Regional Pain Syndrome Type 1: A Randomized Controlled Study. Arch Phys Med Rehabil. 2016 Apr;97(4):575-581. doi: 10.1016/j.apmr.2015.12.008. Epub 2015 Dec 23.
- Vlaeyen JWS, Linton SJ. Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000 Apr;85(3):317-332. doi: 10.1016/S0304-3959(99)00242-0.
- Boesch E, Bellan V, Moseley GL, Stanton TR. The effect of bodily illusions on clinical pain: a systematic review and meta-analysis. Pain. 2016 Mar;157(3):516-529. doi: 10.1097/j.pain.0000000000000423. Review.
- Breivik H, Allen SM, Stubhaug A. Mirror-therapy: An important tool in the management of Complex Regional Pain Syndrome (CRPS). Scand J Pain. 2013 Oct 1;4(4):190-197. doi: 10.1016/j.sjpain.2013.07.019.
- 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.
- de Souza NS, Martins AC, Bastos VH, Orsini M, Leite MA, Teixeira S, Velasques B, Ribeiro P, Bittencourt J, Matta AP, Filho PM. Motor Imagery and Its Effect on Complex Regional Pain Syndrome: An Integrative Review. Neurol Int. 2015 Dec 31;7(3):5962. doi: 10.4081/ni.2015.5962. eCollection 2015 Dec 29. Review.
- de Vries S, Tepper M, Feenstra W, Oosterveld H, Boonstra AM, Otten B. Motor imagery ability in stroke patients: the relationship between implicit and explicit motor imagery measures. Front Hum Neurosci. 2013 Nov 19;7:790. doi: 10.3389/fnhum.2013.00790. eCollection 2013.
- Deconinck FJ, Smorenburg AR, Benham A, Ledebt A, Feltham MG, Savelsbergh GJ. Reflections on mirror therapy: a systematic review of the effect of mirror visual feedback on the brain. Neurorehabil Neural Repair. 2015 May;29(4):349-61. doi: 10.1177/1545968314546134. Epub 2014 Aug 26.
- den Hollander M, Heijnders N, de Jong JR, Vlaeyen JWS, Smeets RJEM, Goossens MEJB. EXPOSURE IN VIVO VERSUS PAIN-CONTINGENT PHYSICAL THERAPY IN COMPLEX REGIONAL PAIN SYNDROME TYPE I: A COST-EFFECTIVENESS ANALYSIS. Int J Technol Assess Health Care. 2018 Jan;34(4):400-409. doi: 10.1017/S0266462318000429. Epub 2018 Jul 26.
- Duong S, Bravo D, Todd KJ, Finlayson RJ, Tran Q. Treatment of complex regional pain syndrome: an updated systematic review and narrative synthesis. Can J Anaesth. 2018 Jun;65(6):658-684. doi: 10.1007/s12630-018-1091-5. Epub 2018 Feb 28.
- Elsamadicy AA, Yang S, Sergesketter AR, Ashraf B, Charalambous L, Kemeny H, Ejikeme T, Ren X, Pagadala P, Parente B, Xie J, Lad SP. Prevalence and Cost Analysis of Complex Regional Pain Syndrome (CRPS): A Role for Neuromodulation. Neuromodulation. 2018 Jul;21(5):423-430. doi: 10.1111/ner.12691. Epub 2017 Sep 29. Review.
- Ezendam D, Bongers RM, Jannink MJ. Systematic review of the effectiveness of mirror therapy in upper extremity function. Disabil Rehabil. 2009;31(26):2135-49. doi: 10.3109/09638280902887768.
- Gregg M, Hall C, Butler A. The MIQ-RS: A Suitable Option for Examining Movement Imagery Ability. Evid Based Complement Alternat Med. 2010 Jun;7(2):249-57. doi: 10.1093/ecam/nem170. Epub 2007 Dec 26.
- Harden RN, Oaklander AL, Burton AW, Perez RS, Richardson K, Swan M, Barthel J, Costa B, Graciosa JR, Bruehl S; Reflex Sympathetic Dystrophy Syndrome Association. Complex regional pain syndrome: practical diagnostic and treatment guidelines, 4th edition. Pain Med. 2013 Feb;14(2):180-229. doi: 10.1111/pme.12033. Epub 2013 Jan 17.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Marchesotti S, Bassolino M, Serino A, Bleuler H, Blanke O. Quantifying the role of motor imagery in brain-machine interfaces. Sci Rep. 2016 Apr 7;6:24076. doi: 10.1038/srep24076.
- 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.
- McInnes K, Friesen C, Boe S. Specific Brain Lesions Impair Explicit Motor Imagery Ability: A Systematic Review of the Evidence. Arch Phys Med Rehabil. 2016 Mar;97(3):478-489.e1. doi: 10.1016/j.apmr.2015.07.012. Epub 2015 Aug 5.
- Meugnot A, Almecija Y, Toussaint L. The embodied nature of motor imagery processes highlighted by short-term limb immobilization. Exp Psychol. 2014;61(3):180-6. doi: 10.1027/1618-3169/a000237.
- Meugnot A, Toussaint L. Functional plasticity of sensorimotor representations following short-term immobilization of the dominant versus non-dominant hands. Acta Psychol (Amst). 2015 Feb;155:51-6. doi: 10.1016/j.actpsy.2014.11.013. Epub 2014 Dec 30.
- Moseley GL. Is successful rehabilitation of complex regional pain syndrome due to sustained attention to the affected limb? A randomised clinical trial. Pain. 2005 Mar;114(1-2):54-61. Epub 2005 Jan 26.
- Moseley GL, Zalucki N, Birklein F, Marinus J, van Hilten JJ, Luomajoki H. Thinking about movement hurts: the effect of motor imagery on pain and swelling in people with chronic arm pain. Arthritis Rheum. 2008 May 15;59(5):623-31. doi: 10.1002/art.23580.
- Oostra KM, Oomen A, Vanderstraeten G, Vingerhoets G. Influence of motor imagery training on gait rehabilitation in sub-acute stroke: A randomized controlled trial. J Rehabil Med. 2015 Mar;47(3):204-9. doi: 10.2340/16501977-1908.
- Pleger B, Ragert P, Schwenkreis P, Förster AF, Wilimzig C, Dinse H, Nicolas V, Maier C, Tegenthoff M. Patterns of cortical reorganization parallel impaired tactile discrimination and pain intensity in complex regional pain syndrome. Neuroimage. 2006 Aug 15;32(2):503-10. Epub 2006 Jun 6.
- Ramachandran VS, Altschuler EL. The use of visual feedback, in particular mirror visual feedback, in restoring brain function. Brain. 2009 Jul;132(Pt 7):1693-710. doi: 10.1093/brain/awp135. Epub 2009 Jun 8.
- Hall M. Opportunity in health visiting. Br Med J. 1978 Dec 9;2(6152):1646.
- Santos-Couto-Paz CC, Teixeira-Salmela LF, Tierra-Criollo CJ. The addition of functional task-oriented mental practice to conventional physical therapy improves motor skills in daily functions after stroke. Braz J Phys Ther. 2013 Nov-Dec;17(6):564-71. doi: 10.1590/S1413-35552012005000123. Epub 2013 Nov 1.
- Sato K, Fukumori S, Matsusaki T, Maruo T, Ishikawa S, Nishie H, Takata K, Mizuhara H, Mizobuchi S, Nakatsuka H, Matsumi M, Gofuku A, Yokoyama M, Morita K. Nonimmersive virtual reality mirror visual feedback therapy and its application for the treatment of complex regional pain syndrome: an open-label pilot study. Pain Med. 2010 Apr;11(4):622-9. doi: 10.1111/j.1526-4637.2010.00819.x. Epub 2010 Mar 1.
- Selles RW, Schreuders TA, Stam HJ. Mirror therapy in patients with causalgia (complex regional pain syndrome type II) following peripheral nerve injury: two cases. J Rehabil Med. 2008 Apr;40(4):312-4. doi: 10.2340/16501977-0158.
- Smart KM, Wand BM, O'Connell NE. Physiotherapy for pain and disability in adults with complex regional pain syndrome (CRPS) types I and II. Cochrane Database Syst Rev. 2016 Feb 24;2:CD010853. doi: 10.1002/14651858.CD010853.pub2. Review. Update in: Cochrane Database Syst Rev. 2022 May 17;5:CD010853.
- Solodkin A, Hlustik P, Chen EE, Small SL. Fine modulation in network activation during motor execution and motor imagery. Cereb Cortex. 2004 Nov;14(11):1246-55. Epub 2004 May 27.
- Thieme H, Morkisch N, Rietz C, Dohle C, Borgetto B. The Efficacy of Movement Representation Techniques for Treatment of Limb Pain--A Systematic Review and Meta-Analysis. J Pain. 2016 Feb;17(2):167-80. doi: 10.1016/j.jpain.2015.10.015. Epub 2015 Nov 6. Review.
- Trojan J, Speck V, Kleinböhl D, Benrath J, Flor H, Maihöfner C. Altered tactile localization and spatiotemporal integration in complex regional pain syndrome patients. Eur J Pain. 2019 Mar;23(3):472-482. doi: 10.1002/ejp.1321. Epub 2018 Nov 12.
- Vladimir Tichelaar YI, Geertzen JH, Keizer D, Paul van Wilgen C. Mirror box therapy added to cognitive behavioural therapy in three chronic complex regional pain syndrome type I patients: a pilot study. Int J Rehabil Res. 2007 Jun;30(2):181-8.
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Disease
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Autonomic Nervous System Diseases
- Syndrome
- Complex Regional Pain Syndromes
- Reflex Sympathetic Dystrophy
- Somatoform Disorders
- Rheumatic Diseases
- Collagen Diseases
- Musculoskeletal Pain
Other Study ID Numbers
- LOCAL/2020/MO-01
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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