Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

8. september 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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)
Annen: 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
Annen: 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).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Nantes University Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

15. mai 2028

Studiet fullført (Antatt)

1. juli 2028

Datoer for studieregistrering

Først innsendt

8. september 2026

Først innsendt som oppfylte QC-kriteriene

8. september 2026

Først lagt ut (Faktiske)

14. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RC25_0515

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere