Neural Bases of Phantom Pain After Amputation

NCT ID: NCT05545358

Last Updated: 2022-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-31

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Phantom Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Amputees with phantom pain

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

Questionnaires

Intervention Type 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)

Brain and Spinal Cord functional Magnetic Resonance Imaging

Intervention Type DEVICE

Brain and Spinal Cord functional Magnetic Resonance Imaging

Proprioceptive training

Intervention Type OTHER

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

Questionnaires

Intervention Type 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)

Brain and Spinal Cord functional Magnetic Resonance Imaging

Intervention Type DEVICE

Brain and Spinal Cord functional Magnetic Resonance Imaging

Healthy participants

Healthy adult participants with no neurological history

Brain and Spinal Cord functional Magnetic Resonance Imaging

Intervention Type DEVICE

Brain and Spinal Cord functional Magnetic Resonance Imaging

Proprioceptive training

Intervention Type OTHER

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

Interventions

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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)

Intervention Type OTHER

Brain and Spinal Cord functional Magnetic Resonance Imaging

Brain and Spinal Cord functional Magnetic Resonance Imaging

Intervention Type DEVICE

Proprioceptive training

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Direction Centrale du Service de Santé des Armées

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2021-A01733-38

Identifier Type: OTHER

Identifier Source: secondary_id

2020PPRC09

Identifier Type: -

Identifier Source: org_study_id

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