Neural Bases of Phantom Pain After Amputation

ConditionPhantom Pain

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-65

SponsorDirection Centrale du Service de Santé des Armées

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Clinically significant pathology (gastrointestinal, renal, hepatic, endocrine, cardiovascular or respiratory)

Progressive psychiatric or neurological pathology

On psychotropic medication

Pregnant or nursing woman

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Questionnaires
Other intervention
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)
Brain and Spinal Cord functional Magnetic Resonance Imaging
Device
Brain and Spinal Cord functional Magnetic Resonance Imaging
Proprioceptive training
Other intervention
Proprioceptive muscular training via a mechanical vibration of low amplitude and frequency between 60 and 80 Hz applied to the tendons.

Treatment groups

75 Participants

are divided into 3 treatment groups

Group A: Amputees with phantom pain3 interventions

Group B: Amputees without phantom pain2 interventions

Group C: Healthy participants2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

Up to 3 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Direction Centrale du Service de Santé des Armées

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: