Graded Motor Imagery Effects on Body Perception Disturbance in Complex Regional Pain Syndrome : a Randomised Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Over 18 years

Upper limb unilateral CRPS (Budapest criteria)

No prior use of GMI

Disqualifiers

Psychiatric disorders

Not confident with written/spoken French

Not confident with smartphone use

Trial design

Design model

Parallel

Treatments tested in this trial

  • Graded Motor Imagery + Therapeutic exercises

    Other intervention

    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-GMI (non-motor mental imagery) + Therapeutic exercises

    Other intervention

    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).

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Group "Graded Motor Imagery + Therapeutic exercises"Experimental treatment 1 intervention
Group B: Group "Sham-GMI (non-motor mental imagery) + Therapeutic exercises"Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Body perception disorders (Bath Scale)

Assessment of body perception disturbances; 7 items

Time frame
End of intervention (Week 6)

Secondary outcomes

1

Body perception disorders (Bath Scale)

Assessment of body perception disturbances; 7 items

Time frame
3 months after intervention (M3)
2

Mean pain intensity (Numeric rating scale)

Mean pain during the last week, mean pain during the last week during movement, mean pain during the last week at rest

Time frame
End of intervention (Week 6), 3 months after intervention (M3)
3

QuickDash

Self-reported assessment of upper limb function :

Time frame
End of intervention (Week 6), 3 months after intervention (M3)
4

PROMIS 29

Self-reported assessment of quality of life (7 domains, 29 items)

Time frame
End of intervention (Week 6), 3 months after intervention (M3)

Other outcomes

Sponsors and contacts

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