Mechanisms and Treatment of Post-amputation Neuropathic Pain
Neuropathic Pain, Phantom Limb Pain, Amputation
About this trial
This is an interventional treatment trial for Neuropathic Pain focused on measuring repetitive transcranial magnetic stimulation, spinal anaesthesia
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Department of Pain Management and Research, Oslo University Hospital and Faculty of Medicine, University of Oslo,
Arms of the Study
Arm 1
Arm 2
Other
Other
Active and then sham repetitive transcranial magnetic stimulation
Sham and then active repetitive transcranial magnetic stimulation
Deep rTMS is delivered with the Brainsway H7-coil (Brainsway, Jerusalem, Israel) applied via a helmet placed on the head targeting the primary motor cortex of the leg. Sham stimulation is delivered with a sham coil placed in the helmet encasing the active rTMS coil. Sham rTMS sessions will use exactly the same parameters of stimulation as active rTMS.
Deep rTMS is delivered with the Brainsway H7-coil (Brainsway, Jerusalem, Israel) applied via a helmet placed on the head targeting the primary motor cortex of the leg.Sham stimulation is delivered with a sham coil placed in the helmet encasing the active rTMS coil. Sham rTMS sessions will use exactly the same parameters of stimulation as active rTMS.