Neural Bases of Phantom Pain After Amputation (Phantom limb)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Phantom Pain
• Intervention / Treatment: Other: Questionnaires; Device: Brain and Spinal Cord functional Magnetic Resonance Imaging; Other: Proprioceptive training

• Study Type: Observational
• Enrollment (Anticipated): 75

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of :

• patients who have been amputated for more than 2 years and have chronic phantom pain;
• patients who have been amputated for more than 2 years and do not have chronic phantom pain;
• healthy participants with no neurological history. The patients will be recruited from the cohort of amputee patients followed by the Physical Medicine and Rehabilitation departments of the Hôpital d'Instruction des Armées Laveran, the Hôpital d'Instruction des Armées Desgenettes and the CHU de Saint-Etienne.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Amputees with phantom pain; Adult patients who have been amputated for more than 2 years and have chronic phantom pain	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 (SF-EHI) Patient's Global Impression of Change (PGIC); 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.
Amputees without phantom pain; Adult patients who have been amputated for more than 2 years and do not have chronic phantom pain	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 (SF-EHI) Patient's Global Impression of Change (PGIC); Device: Brain and Spinal Cord functional Magnetic Resonance Imaging; Brain and Spinal Cord functional Magnetic Resonance Imaging
Healthy participants; Healthy adult participants with no neurological history	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in brain activity, measured through fMRI, following proprioceptive training	Brain activity (BOLD hemodynamic response) will be measured via fMRI before and after proprioceptive training sessions.	Up to 3 months
Change in spinal cord activity, measured through spinal fMRI, following proprioceptive training	Spinal cord activity (BOLD hemodynamic response) will be measured via spinal fMRI before and after proprioceptive training sessions.	Up to 3 months

Collaborators and Investigators

• Sponsor: Direction Centrale du Service de Santé des Armées

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): October 1, 2026
• Study Completion (Anticipated): October 1, 2026

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: fMRI; spinal fMRI
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Pain, Postoperative; Phantom Limb
• Other Study ID Numbers: 2020PPRC09; 2021-A01733-38 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No