Status:
TERMINATED
Mechanisms and Treatment of Post-amputation Neuropathic Pain
Lead Sponsor:
Oslo University Hospital
Conditions:
Neuropathic Pain
Phantom Limb Pain
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Phantom and residual limb pain are types of peripheral neuropathic pain that are difficult to treat and where the underlying mechanisms are still not fully understood. Repetitive transcranial magnetic...
Eligibility Criteria
Inclusion
- 18-80 years of age
- Unilateral or bilateral lower limb amputation resulting in residual limb pain and/or phantom pain, fulfilling the criteria for definite neuropathic pain
- Usual pain intensity at least 4/10 over the past 24 hrs using the numerical scale of the BPI at screening
- Daily pain
- Pain for at least 3 months
- Stable pharmacological treatment for pain or no pharmaceutical treatment at least 1 month prior to the study
- Patients who can be followed for the whole duration of the study
- Minimum 4/10 pain intensity at the time of spinal anaesthesia for sub-study 1
Exclusion
- Any clinically significant or unstable medical or psychiatric disorder
- Subjects protected by law (guardianship or tutelage measure)
- History of or current substance abuse (alcohol, drugs)
- Pending litigation
- Contraindications to spinal anaesthetic block (e.g. use of prescribed or non-prescribed medication that can increase risk of bleeding such as anticoagulants, non-steroidal anti-inflammatory drugs and acetylsalicylic acid)
- Contraindication to rTMS (past severe head trauma, history of epilepsy or ongoing epilepsy, active cerebral tumour, past neurosurgical intervention, intracranial hypertension, implanted devices not compatible such as cardiac pacemaker and neurostimulator, cochlear implants, pregnancy or lactation. All women of childbearing age will be required to have negative pregnancy test at inclusion and to be using contraception)
- Other pain conditions more severe than phantom and residual limb pain.
- Inability to understand the protocol or to fill out the forms
- Other ongoing research protocol or recent past protocol within one month before the inclusion
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04819503
Start Date
January 1 2021
End Date
December 3 2021
Last Update
November 29 2023
Active Locations (1)
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1
Department of Pain Management and Research, Oslo University Hospital and Faculty of Medicine, University of Oslo,
Oslo, Norway, 0424