Phantom PainPhantom limbNCT05545358
Neural Bases of Phantom Pain After Amputation
An observational study of Phantom Pain, run by Direction Centrale du Service de Santé des Armées.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Phantom Pain
- What is being tested?
- Questionnaires, Brain and Spinal Cord functional Magnetic Resonance Imaging and Proprioceptive training
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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
- Being tested
- Questionnaires, Brain and Spinal Cord functional Magnetic Resonance Imaging, Proprioceptive training
- Keywords
- fMRI, spinal fMRI
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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 ImagingDevice
Brain and Spinal Cord functional Magnetic Resonance Imaging
Proprioceptive trainingOther
Proprioceptive muscular training via a mechanical vibration of low amplitude and frequency between 60 and 80 Hz applied to the tendons.
| Study group | Role | What they receive |
|---|---|---|
| Amputees with phantom pain | Adult patients who have been amputated for more than 2 years and have chronic phantom pain Receives: 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 Receives: Other: Questionnaires; Device: Brain and Spinal Cord functional Magnetic Resonance Imaging | |
| Healthy participants | Healthy adult participants with no neurological history Receives: Device: Brain and Spinal Cord functional Magnetic Resonance Imaging; Other: Proprioceptive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phantom PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545358
- Sponsor's protocol ID
- 2020PPRC09
- Other IDs
- 2021-A01733-38
- Acronym
- Phantom limb
- Status last verified
- Sep 2022
- First submitted
- 12 Sep 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05545358
- Acronym / sponsor ID
- Phantom limb / 2020PPRC09
- Conditions
- Phantom Pain
- Keywords
- fMRI, spinal fMRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amputees with phantom pain | – | Other: Questionnaires, Device: Brain and Spinal Cord functional Magnetic Resonance Imaging, Other: Proprioceptive trainingAdult patients who have been amputated for more than 2 years and have chronic phantom pain |
| Amputees without phantom pain | – | Other: Questionnaires, Device: Brain and Spinal Cord functional Magnetic Resonance ImagingAdult patients who have been amputated for more than 2 years and do not have chronic phantom pain |
| Healthy participants | – | Device: Brain and Spinal Cord functional Magnetic Resonance Imaging, Other: Proprioceptive trainingHealthy adult participants with no neurological history |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesShort-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) | Other | Amputees with phantom pain, Amputees without phantom pain |
| Brain and Spinal Cord functional Magnetic Resonance ImagingBrain and Spinal Cord functional Magnetic Resonance Imaging | Device | Amputees with phantom pain, Amputees without phantom pain, Healthy participants |
| Proprioceptive trainingProprioceptive muscular training via a mechanical vibration of low amplitude and frequency between 60 and 80 Hz applied to the tendons. | Other | Amputees with phantom pain, Healthy participants |
Primary outcome
Change in brain activity, measured through fMRI, following proprioceptive training
Time frame: Up to 3 months
Brain activity (BOLD hemodynamic response) will be measured via fMRI before and after proprioceptive training sessions.
Change in spinal cord activity, measured through spinal fMRI, following proprioceptive training
Time frame: Up to 3 months
Spinal cord activity (BOLD hemodynamic response) will be measured via spinal fMRI before and after proprioceptive training sessions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Phantom Pain, run by Direction Centrale du Service de Santé des Armées.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brain activity, measured through fMRI, following proprioceptive training (time frame: Up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.