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

2026年9月8日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Sessi ACAPO, Doctor of Science
  • 电话号码：+33 02 51 83 11 72
  • 邮箱：sessi.acapo@gmail.com

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：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)
其他：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
假比较器：Group "Sham-GMI (non-motor mental imagery) + Therapeutic exercises"
Sham-GMI (non-motor mental imagery) + Therapeutic exercises
其他：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).

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Body perception disorders (Bath Scale)
大体时间：End of intervention (Week 6)
Assessment of body perception disturbances; 7 items
End of intervention (Week 6)

次要结果测量

结果测量
措施说明
大体时间
Body perception disorders (Bath Scale)
大体时间：3 months after intervention (M3)
Assessment of body perception disturbances; 7 items
3 months after intervention (M3)
Mean pain intensity (Numeric rating scale)
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Nantes University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2028年5月15日

研究完成 (估计的)

2028年7月1日

研究注册日期

首次提交

2026年9月8日

首先提交符合 QC 标准的

2026年9月8日

首次发布 (实际的)

2026年9月14日

研究记录更新

最后更新发布 (实际的)

2026年9月14日

上次提交的符合 QC 标准的更新

2026年9月8日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • RC25_0515

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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