- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07818174
Graded Motor Imagery Effects on Body Perception Disturbance in Complex Regional Pain Syndrome : a Randomised Controlled Trial (Bath-Min)
Complex Regional Pain Syndrome (CRPS) is a debilitating pain condition that usually develops following trauma. Patients with CRPS experience intense, continuing, disproportionate pain and multiple symptoms such as changes or asymmetry in colour, temperature or oedema, as well as stiffness, tremors or dystonia and body perception disturbances. Body perception disturbances are now recognised as part of the typical presentation of CRPS and have been shown to correlate, in particular, with pain intensity.
Managing CRPS is challenging and treatment options are limited. Among these, treatments aimed at cortical reorganisation, such as Graded Motor Imagery (GMI), have shown evidence of efficacy in terms of pain and function. However, with regard to body perception disorders, the evidence is limited and emerging.
Our aim is to evaluate the effects of Graded Motor Imagery on body perception disorders in patients with upper limb CRPS. Method: a randomised controlled trial comparing an intervention group - therapeutic exercises plus GMI for 6 weeks (implicit motor imagery, explicit motor imagery followed by mirror therapy) - with a control group - therapeutic exercises plus sham-GMI (non-motor mental imagery) for 6 weeks.
Outcome measures: body perception disorders (Bath Scale), pain intensity (Numerical Rating Scale), quality of life (PROMIS 29), catastrophising (PCS), fear of pain, CRPS Severity Score, patient-reported global impression of change, medication use and self-efficacy. Interventions are carried out in private practice by independent physiotherapists. Assessors are blinded for the primary outcome. A qualitative component will explore the experiences and perceptions of patients and therapists regarding body perception disturbances, GMI and participation in a research project.
This study aims are to improve treatment options for the management of SDRC and to improve the recognition and treatment of body perception disorders in SDRC.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sessi ACAPO, Doctor of Science
- Phone Number: +33 02 51 83 11 72
- Email: sessi.acapo@gmail.com
Study Locations
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Ambon, France, 56190
- Cabinet de kinésithérapie AMBON 56190 3b route de Lauzach
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Contact:
- Amaury BRIDOUX, Physical therapist
- Phone Number: 02 97 68 70 54
- Email: amaury.bridoux@gmail.com
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Principal Investigator:
- Amaury BRIDOUX, Physical therapist
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Caen, France, 14000
- Cabinet de kinésithérapie, CAEN 14000 41 av. père Charles de Foucauld
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Contact:
- Guillaume GALLIOU, Physical therapist
- Phone Number: 02 31 83 48 02
- Email: guillaume.galliou@gmail.com
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Principal Investigator:
- Guillaume GALLIOU, Physical therapist
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Cugand, France, 85610
- Cabinet de kinésithérapie, 85610 CUGAND 19bis rue du président auguste durand
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Contact:
- Victor DUPONT, Physical therapist
- Phone Number: 02 51 42 11 92
- Email: victor.dupont@hotmail.fr
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Principal Investigator:
- Victor DUPONT, Physical therapist
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Guidel, France, 56520
- Cabinet de kinésithérapie, 56520 6 place Louis le Montagner
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Contact:
- Germain PICHOT, Physical therapist
- Phone Number: 02 97 02 92 53
- Email: pichot.germain@gmail.com
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Principal Investigator:
- Germain PICHOT, Physical therapist
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L'Île-Rousse, France, 20220
- Cabinet de kinésithérapie, 20220 L'ILE ROUSSE 8 Bd Pasquini
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Contact:
- Florian SANTOS, Physical therapist
- Phone Number: 04 95 60 00 41
- Email: santos_florian@hotmail.fr
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Principal Investigator:
- FLORIAN SANTOS
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Lyon, France, 69008
- Cabinet de kinésithérapie, 69008 LYON 16 rue du transvaal
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Contact:
- Aissaoui TESSADIT, Physical therapist
- Phone Number: 09 82 41 60 55
- Email: Tessadit.aissaoui@gmail.com
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Principal Investigator:
- Aissaoui TESSADIT, Physical therapist
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Montpellier, France, 34000
- Cabinet de kinésithérapie, 34000 Montpellier, 22, avenue du Pont Juvénal
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Contact:
- Fabrice ERNOUL, Physical therapist
- Phone Number: 04 67 27 75 43
- Email: 73fabrices@gmail.com
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Principal Investigator:
- Fabrice ERNOUL, Physical therapist
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Nantes, France, 44000
- Cabinet de kinésithérapie du Mail Pablo Picasso, 5 Rue Nina Simone,
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Contact:
- Sessi ACAPO, Doctor of Science
- Phone Number: +33 02 51 83 11 72
- Email: sessi.acapo@gmail.com
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Principal Investigator:
- Sessi ACAPO, Doctor of Science
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Nantes, France, 44100
- Cabinet de kinésithérapie, 44100 NANTES 7 RUE DU SIMOUN
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Contact:
- Clotilde SANDER, Physical therapist
- Phone Number: 02 51 84 87 71
- Email: Clotilde.sander@gmail.com
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Principal Investigator:
- Clotilde SANDER, Physical therapist
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Nantes, France, 44100
- cabinet de kinésithérapie, 44100 NANTES 8ter rue de la convention
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Contact:
- Maeva GELU, Physical therapist
- Phone Number: 06 98 32 97 00
- Email: maeva.gelu.mk@gmail.com
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Principal Investigator:
- Maeva GELU, Physical therapist
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Nantes, France, 44100
- cabinet de kinésithérapie, NANTES 44100 2-4 route de Paris
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Contact:
- Emeline LEBOEUF, Physical therapist
- Phone Number: 02 28 16 88 47
- Email: kine.e.leboeuf@gmail.com
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Principal Investigator:
- Emeline LEBOEUF, Physical therapist
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Orléans, France, 45100
- Cabinet de kinésithérapie, 45100 Orléans 44 avenue de la Mouillère
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Contact:
- Nolwenn POQUET, Physical therapist
- Phone Number: 0238635472
- Email: poquet.nolwenn@gmail.com
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Principal Investigator:
- Nolwenn POCQUET, Physical therapist
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Paris, France, 75019
- Cabinet de kinésithérapie, PARIS 75019 2, rue de Sadi Lecointe
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Contact:
- Kader NDIAYE, Physical therapist
- Phone Number: 06 68 51 97 52
- Email: kader.ndiaye.kine@gmail.com
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Principal Investigator:
- Kader NDIAYE, Physical therapist
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Rezé, France, 44400
- Cabinet de kinésithérapie, 44400 REZE 15 avenue Louise Michel
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Contact:
- Damien HRYNKOW, Physical therapist
- Phone Number: 02 40 40 80 52
- Email: damien.hrynkow@gmail.com
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Principal Investigator:
- Damien HRYNKOW, Physical therapist
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Saint-Herblain, France, 44800
- cabinet de kinésithérapie, 44800 St Herblain Boulevard charles gautier
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Contact:
- Léa GUILBEAU, Physical therapist
- Phone Number: 02 51 84 87 71
- Email: lea.guilbeau@laposte.net
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Principal Investigator:
- Léa GUILBEAU, Physical therapist
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Saint-Yorre, France, 03270
- cabinet de kinésithérapie, 03270 SAINTYORRE 10, rue de la République
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Contact:
- Philippe DEAT, Physical therapist
- Phone Number: 04 70 41 04 37
- Email: philippe.deat@gmx.fr
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Principal Investigator:
- Philippe DEAT, Physical therapist
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Serres-Castet, France, 64121
- Cabinet de kinésithérapie, 64121 Serres Castet 7 bis chemin de Liben
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Contact:
- Florent JACQUEMIN, Physical therapist
- Phone Number: 05 47 41 43 68
- Email: Jacquemin.florent@yahoo.fr
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Principal Investigator:
- Florent JACQUEMIN, Physical therapist
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Éragny, France, 95610
- Cabinet de kinésithérapie, ERAGNY 95610 5 allée Rosa Luxemburg
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Contact:
- Audrey VIERS, Physical therapist
- Phone Number: 01 39 09 14 73
- Email: audrey.viers@outlook.com
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Principal Investigator:
- Audrey VIERS, Physical therapist
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Over 18 years
- Upper limb unilateral CRPS (Budapest criteria)
- No prior use of GMI
Exclusion Criteria:
- Psychiatric disorders
- Not confident with written/spoken French
- Not confident with smartphone use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group "Graded Motor Imagery + Therapeutic exercises"
Graded Motor Imagery (left/right discrimination, explicit motor imagery, mirror therapy) and exercises (15 minutes, 3 times per day, 6 weeks)
|
Functional, mobility, strengthening, and mobilization exercises, both passive and active. The exercises are designed to improve mobility and function in the affected limb. In addition to this standard treatment, the intervention group will receive care using Gradual Motor Imagery. The protocol lasts 6 weeks (3 sessions of 15 minutes per day), divided into 3 phases: implicit motor imagery, explicit motor imagery followed by mirror therapy |
|
Sham Comparator: Group "Sham-GMI (non-motor mental imagery) + Therapeutic exercises"
Sham-GMI (non-motor mental imagery) + Therapeutic exercises
|
Functional, mobility, strengthening, and mobilization exercises, both passive and active. The exercises are designed to improve mobility and function in the affected limb. In addition to this standard treatment, the control group will receive a non-motor mental imagery intervention (visual imagery or sham-GMI), designed not to stimulate the sensorimotor areas of the brain while resembling IMG (3 sessions of 15 minutes per day for 6 weeks). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body perception disorders (Bath Scale)
Time Frame: End of intervention (Week 6)
|
Assessment of body perception disturbances; 7 items
|
End of intervention (Week 6)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body perception disorders (Bath Scale)
Time Frame: 3 months after intervention (M3)
|
Assessment of body perception disturbances; 7 items
|
3 months after intervention (M3)
|
|
Mean pain intensity (Numeric rating scale)
Time Frame: End of intervention (Week 6), 3 months after intervention (M3)
|
Mean pain during the last week, mean pain during the last week during movement, mean pain during the last week at rest
|
End of intervention (Week 6), 3 months after intervention (M3)
|
|
QuickDash
Time Frame: End of intervention (Week 6), 3 months after intervention (M3)
|
Self-reported assessment of upper limb function :
|
End of intervention (Week 6), 3 months after intervention (M3)
|
|
PROMIS 29
Time Frame: End of intervention (Week 6), 3 months after intervention (M3)
|
Self-reported assessment of quality of life (7 domains, 29 items)
|
End of intervention (Week 6), 3 months after intervention (M3)
|
|
Pain Catastrophizing Scale (PCS)
Time Frame: End of intervention (Week 6), 3 months after intervention (M3)
|
Self-reported assessment of pain catastrophizing
|
End of intervention (Week 6), 3 months after intervention (M3)
|
|
Tampa Scale of Kinesiophobia (short form)
Time Frame: End of intervention (Week 6), 3 months after intervention (M3)
|
Self-reported assessment of fear of movement (6 items)
|
End of intervention (Week 6), 3 months after intervention (M3)
|
|
Pain Self Efficacy Questionnaire (PSEQ)
Time Frame: End of intervention (Week 6), 3 months after intervention (M3)
|
Self-reported assessment of confidence in performing activities despite ongoing pain
|
End of intervention (Week 6), 3 months after intervention (M3)
|
|
Patient Global Impression of Change (PGIC)
Time Frame: End of intervention (Week 6), 3 months after intervention (M3)
|
Self-administered questions asking respondents to rate how their condition has changed since the intervention
|
End of intervention (Week 6), 3 months after intervention (M3)
|
|
Medication Quantification Scale (MQS)
Time Frame: End of intervention (Week 6), 3 months after intervention (M3)
|
MQS quantifies pain medication use and provides a score.
|
End of intervention (Week 6), 3 months after intervention (M3)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- Pain
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Autonomic Nervous System Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Chronic Pain
- Complex Regional Pain Syndromes
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Exercise Therapy
Other Study ID Numbers
- RC25_0515
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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