Neural Bases of Phantom Pain After Amputation

NCT05545358 | Not Yet Recruiting

• 2 other identifiers: 2020PPRC092021-A01733-38
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Phantom Pain

Keywords

fMRI; spinal fMRI

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Amputees with phantom pain

Adult patients who have been amputated for more than 2 years and have chronic phantom pain

Other: Questionnaires; Device: Brain and Spinal Cord functional Magnetic Resonance Imaging; Other: Proprioceptive training

Amputees without phantom pain

Adult patients who have been amputated for more than 2 years and do not have chronic phantom pain

Other: Questionnaires; Device: 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; Other: Proprioceptive training

Interventions

Questionnaires OTHER

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)

Amputees with phantom pain; Amputees without phantom pain

Brain and Spinal Cord functional Magnetic Resonance Imaging DEVICE

Brain and Spinal Cord functional Magnetic Resonance Imaging

Amputees with phantom pain; Amputees without phantom pain; Healthy participants

Proprioceptive training OTHER

Proprioceptive muscular training via a mechanical vibration of low amplitude and frequency between 60 and 80 Hz applied to the tendons.

Amputees with phantom pain; Healthy participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

MeSH Terms

Conditions

Phantom Limb

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 19, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 19, 2022

Record last verified: 2022-09