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Graded Motor Imagery Effects on Body Perception Disturbance in Complex Regional Pain Syndrome : a Randomised Controlled Trial (Bath-Min)

8. september 2026 opdateret af: Nantes University Hospital

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
      • Ambon, Frankrig, 56190
        • Cabinet de kinésithérapie AMBON 56190 3b route de Lauzach
        • Kontakt:
        • Ledende efterforsker:
          • Amaury BRIDOUX, Physical therapist
      • Caen, Frankrig, 14000
        • Cabinet de kinésithérapie, CAEN 14000 41 av. père Charles de Foucauld
        • Kontakt:
        • Ledende efterforsker:
          • Guillaume GALLIOU, Physical therapist
      • Cugand, Frankrig, 85610
        • Cabinet de kinésithérapie, 85610 CUGAND 19bis rue du président auguste durand
        • Kontakt:
        • Ledende efterforsker:
          • Victor DUPONT, Physical therapist
      • Guidel, Frankrig, 56520
        • Cabinet de kinésithérapie, 56520 6 place Louis le Montagner
        • Kontakt:
        • Ledende efterforsker:
          • Germain PICHOT, Physical therapist
      • L'Île-Rousse, Frankrig, 20220
        • Cabinet de kinésithérapie, 20220 L'ILE ROUSSE 8 Bd Pasquini
        • Kontakt:
        • Ledende efterforsker:
          • FLORIAN SANTOS
      • Lyon, Frankrig, 69008
        • Cabinet de kinésithérapie, 69008 LYON 16 rue du transvaal
        • Kontakt:
        • Ledende efterforsker:
          • Aissaoui TESSADIT, Physical therapist
      • Montpellier, Frankrig, 34000
        • Cabinet de kinésithérapie, 34000 Montpellier, 22, avenue du Pont Juvénal
        • Kontakt:
        • Ledende efterforsker:
          • Fabrice ERNOUL, Physical therapist
      • Nantes, Frankrig, 44000
        • Cabinet de kinésithérapie du Mail Pablo Picasso, 5 Rue Nina Simone,
        • Kontakt:
        • Ledende efterforsker:
          • Sessi ACAPO, Doctor of Science
      • Nantes, Frankrig, 44100
        • Cabinet de kinésithérapie, 44100 NANTES 7 RUE DU SIMOUN
        • Kontakt:
        • Ledende efterforsker:
          • Clotilde SANDER, Physical therapist
      • Nantes, Frankrig, 44100
        • cabinet de kinésithérapie, 44100 NANTES 8ter rue de la convention
        • Kontakt:
        • Ledende efterforsker:
          • Maeva GELU, Physical therapist
      • Nantes, Frankrig, 44100
        • cabinet de kinésithérapie, NANTES 44100 2-4 route de Paris
        • Kontakt:
        • Ledende efterforsker:
          • Emeline LEBOEUF, Physical therapist
      • Orléans, Frankrig, 45100
        • Cabinet de kinésithérapie, 45100 Orléans 44 avenue de la Mouillère
        • Kontakt:
        • Ledende efterforsker:
          • Nolwenn POCQUET, Physical therapist
      • Paris, Frankrig, 75019
        • Cabinet de kinésithérapie, PARIS 75019 2, rue de Sadi Lecointe
        • Kontakt:
        • Ledende efterforsker:
          • Kader NDIAYE, Physical therapist
      • Rezé, Frankrig, 44400
        • Cabinet de kinésithérapie, 44400 REZE 15 avenue Louise Michel
        • Kontakt:
        • Ledende efterforsker:
          • Damien HRYNKOW, Physical therapist
      • Saint-Herblain, Frankrig, 44800
        • cabinet de kinésithérapie, 44800 St Herblain Boulevard charles gautier
        • Kontakt:
        • Ledende efterforsker:
          • Léa GUILBEAU, Physical therapist
      • Saint-Yorre, Frankrig, 03270
        • cabinet de kinésithérapie, 03270 SAINTYORRE 10, rue de la République
        • Kontakt:
        • Ledende efterforsker:
          • Philippe DEAT, Physical therapist
      • Serres-Castet, Frankrig, 64121
        • Cabinet de kinésithérapie, 64121 Serres Castet 7 bis chemin de Liben
        • Kontakt:
        • Ledende efterforsker:
          • Florent JACQUEMIN, Physical therapist
      • Éragny, Frankrig, 95610
        • Cabinet de kinésithérapie, ERAGNY 95610 5 allée Rosa Luxemburg
        • Kontakt:
        • Ledende efterforsker:
          • Audrey VIERS, Physical therapist

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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)
Andet: Graded Motor 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 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-komparator: Group "Sham-GMI (non-motor mental imagery) + Therapeutic exercises"
Sham-GMI (non-motor mental imagery) + Therapeutic exercises
Andet: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body perception disorders (Bath Scale)
Tidsramme: End of intervention (Week 6)
Assessment of body perception disturbances; 7 items
End of intervention (Week 6)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body perception disorders (Bath Scale)
Tidsramme: 3 months after intervention (M3)
Assessment of body perception disturbances; 7 items
3 months after intervention (M3)
Mean pain intensity (Numeric rating scale)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nantes University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

15. maj 2028

Studieafslutning (Anslået)

1. juli 2028

Datoer for studieregistrering

Først indsendt

8. september 2026

Først indsendt, der opfyldte QC-kriterier

8. september 2026

Først opslået (Faktiske)

14. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RC25_0515

Plan for individuelle deltagerdata (IPD)

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