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Neural Bases of Phantom Pain After Amputation

Observational Phantom Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaires, Brain and Spinal Cord functional Magnetic Resonance Imaging, Proprioceptive training.
Who it may be relevant to
Registry conditions: Phantom Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Experimental Study of the Neural Bases of Phantom Pain After Amputation and Their Modification by Proprioceptive Training: MRI Study of the Brain and Spinal Cord

Overview

The amputation of a limb results in chronic pain associated with the lost limb in the majority of patients, which persists over time. Despite a large number of studies conducted in an attempt to elucidate the neural basis of phantom pain, these are still not elucidated and current treatments often fail to relieve patients' pain.

Interventions

  • Other Questionnaires
    Short-Form McGill Pain Questionnaire (SF-MPQ) Pain Disability Index (PDI) Prosthesis Evaluation Questionnaire (PEQ) Psychological Inflexibility to Pain Scale (PIPS) Chronic Pain Acceptance Questionnaire (CPAQ) Cognitive Difficulties Scale (CDS) Amputee Body Image Scale (ABIS) Trinity Amputation and Prosthesis Experience Scales (TAPES) Pain Catastrophizing Scale (PCS) Hospital Anxiety and Depression Scale (HAD) Credibility/Expectancy Questionnaire (CEQ) Short-Form Edinburgh Handedness Inventory (
  • Device Brain and Spinal Cord functional Magnetic Resonance Imaging
    Brain and Spinal Cord functional Magnetic Resonance Imaging
  • Other Proprioceptive training
    Proprioceptive muscular training via a mechanical vibration of low amplitude and frequency between 60 and 80 Hz applied to the tendons.

Primary outcome measures

  • Change in brain activity, measured through fMRI, following proprioceptive training [Time frame: Up to 3 months]
  • Change in spinal cord activity, measured through spinal fMRI, following proprioceptive training [Time frame: Up to 3 months]

Eligibility criteria

Inclusion criteria

  • Between 18 and 65 years old
  • For the "amputees with phantom pain" group: patients who have been amputated for more than 2 years and have chronic phantom pain
  • For the "amputees without phantom pain" group: patients who have been amputated for more than 2 years and do not have chronic phantom pain
  • For the "healthy participants" group: healthy participants with no neurological history

Exclusion criteria

  • Clinically significant pathology (gastrointestinal, renal, hepatic, endocrine, cardiovascular or respiratory)
  • Progressive psychiatric or neurological pathology
  • On psychotropic medication
  • Pregnant or nursing woman
  • Inadequate level of French language

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05545358 · 2020PPRC09 · 2021-A01733-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗