Treatment of Peripheral Neuropathic Pain
- Conditions
- Neuropathic Pain
- Interventions
- Device: repetitive Transcranial Magnetic Stimulation
- Registration Number
- NCT05488808
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
Peripheral neuropathic pain is a disabling chronic pain condition that is difficult to treat. Repetitive transcranial magnetic stimulation (rTMS) to the motor cortex is a treatment method with growing evidence in its ability to alleviate neuropathic pain. This also applies to new deep rTMS coils which permits stimulation of larger cortical areas and with deeper penetration. The aim of this study is to investigate the analgesic efficacy of 5 days of deep rTMS compared to sham stimulation. We will also assess effects of deep rTMS on sleep, psychological fatctors, everyday functioning, and executive functioning.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
- 18-80 years of age
- Peripheral neuropathic pain related to postherpetic neuralgia, peripheral nerve injury, limb amputation, polyneuropathy or radiculopathy, fulfilling the criteria for probable or definite neuropathic pain (Finnerup et al. 2016)
- 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 inclusion participation
- Ability to follow throughout the whole duration of the study
atients with phantom limb pain after limb amputation
- 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
- 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)
- Pain conditions more severe than peripheral neuropathic 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Active and then sham rTMS 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 arm. Sham and the active rTMS repetitive Transcranial Magnetic Stimulation 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.
- Primary Outcome Measures
Name Time Method Usual pain intensity over the past 24 hours Analgesic efficacy of active and sham treatment is measured as the change in pain intensity scores between baseline values (one week before treatment) and 1 week after the last stimulation. Measurement ends 3 weeks after last stimulation] Measured every day in a diary at the same hour (end of the day) on an 11-point NRS (0 = no pain, 10 = worst pain intensity imaginable of the current pain condition)
- Secondary Outcome Measures
Name Time Method Intensity of dynamic mechanical allodynia Baseline, 1 week and 3 weeks after the end of each stimulation period Dynamic mechanical allodynia is assessed using a brush (SOMEDIC). The outcome is the mean pain intensity of 3 brush strokes within 2 seconds intervals. The length of the brush stroke is 3 cm, measured on an 11-point NRS (0 = no pain, 10 = worst pain intensity imaginable), disregarding the spontaneous ongoing pain.
Pain intensity over the last 24 hours Baseline, 1 week and 3 weeks after the end of each stimulation period Maximum and minimum pain intensity hours, rated from 0 (no pain) to 10 (pain as bad as you can imagine)
Patient Global Impression of Change Baseline,1 week and 3 weeks after the end of each stimulation period Consists of 7 items to evaluate the subjective improvement or deterioration (from very much improved to very much deteriorated)
Blinding 3 weeks after the end of each stimulation period Blinding questionnaire
Usual pain intensity over the past 24 hours Analgesic efficacy of active and sham treatment is measured as the change in pain intensity scores between baseline values and 3 weeks after the last stimulation Measured every day in a diary at the same hour on an 11-point NRS (0 = no pain, 10 = worst pain intensity imaginable of the current pain condition)
Pain unpleasantness during the last 24 hours Baseline, 1 week and 3 weeks after the end of each stimulation period Maximum, minimum, and usual pain unpleasantness, rated from 0 (no pain/unpleasantness) to 10 (unpleasantness as bad as you can imagine)
Proportion of responders Baseline,1 week and 3 weeks after the end of each stimulation period] Proportion of responders with at least 30% and 50% usual pain intensity reduction compared to prestimulation values allowing to calculate Numbers Needed to Treat for 30 % and 50 % pain relief.
Hospital Anxiety and Depression Scale Baseline,1 week and 3 weeks after the end of each stimulation period The Hospital Anxiety and Depression Scale includes 14 items scored as anxiety and depression scores, 7 items assessing depression and 7 anxiety
Intensity of static mechanical allodynia Baseline, 1 week and 3 weeks after the end of each stimulation period Static mechanical allodynia is measured with a stimulus lightly indenting the skin for 10 seconds. The outcome is the mean pain intensity of three presses, measured on an 11-point NRS (0 = no pain, 10 = worst pain intensity imaginable), disregarding the spontaneous ongoing pain.
Percentage pain intensity reduction Baseline,1 week and 3 weeks after the end of each stimulation period Percentage pain intensity reduction on an 11-point NRS (0 %= no pain reduction; 100% complete pain reduction)
Pain Catastrophizing Scale Baseline,1 week and 3 weeks after the end of each stimulation period Consists of 13 items describing the occurrence of thoughts and feelings that individuals may experience when in pain rated from 0 (not at all) to 4 (all the time)
Insomnia Severity Index Baseline,1 week and 3 weeks after the end of each stimulation period Consists of self-rated questions which maps sleep difficulties specific to insomnia on a 5 point Likert scale
Patient-Specific Functional Scale Baseline,1 week and 3 weeks after the end of each stimulation period The Patient-Specific Functional Scale is a numeric rating scale that measures individually chosen functions that are inhibited by the pain. Patients rate from 0 (unable to perform activity) to 10 (able to perform activity)
Executive functioning using the CANTAB battery Baseline,1 week and 3 weeks after the end of each stimulation period Composite score and individual analyses of the paired associates learning test, stop signal task, spatial working memory test and the multitasking test weeks after the end of each stimulation period
Side-effects Immediately after the first rTMS session for both stimulation periods and 1 week and 3 weeks after each stimulation period Side effects using a specific side effects questionnaire specifically designed for assessment of safety in rTMS studies
Trial Locations
- Locations (1)
Department of Pain Management and Research, Oslo University Hospital and Faculty of Medicine, University of Oslo,
🇳🇴Oslo, Norway