Neuropathic PainNCT04819503
Mechanisms and Treatment of Post-amputation Neuropathic Pain
A study testing Spinal anaesthesia (sub-study 1) and Repetitive transcranial magnetic stimulation (sub-study 2) in people with Neuropathic Pain and Phantom Limb Pain, run by Oslo University Hospital at 1 site in Norway.
Trial 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 stimulation (rTMS) of the motor cortex is an increasingly studied technique for the treatment of neuropathic pain and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuropathic Pain, Phantom Limb Pain, Amputation
- What is being tested?
- Spinal anaesthesia (sub-study 1) and Repetitive transcranial magnetic stimulation (sub-study 2)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2021to 3 Dec 2021
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Pain Management and Research, Oslo University Hospital and Faculty of Medicine, University of Oslo,
Oslo, 0424
About this study
Official title: Dependency of the Peripheral Nervous System as a Driver for Post-amputation Pain and Therapeutic Effects of Deep Repetitive Transcranial Magnetic Stimulation in a Randomized Double-blind Sham-controlled Study
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 stimulation (rTMS) of the motor cortex is an increasingly studied technique for the treatment of neuropathic pain and has shown modest effects in pain intensity reduction for the treatment of neuropathic pain. Newer rTMS coils provide the opportunity to stimulate larger brain areas, which could provide a better treatment option compared to conventional coils. The aims of this study are to investigate whether the peripheral nervous system is a necessary driver of phantom limb pain and/or residual limb pain in patients with lower limb amputation using spinal anaesthesia, and to assess the analgesic efficacy of deep H-coil rTMS compared to sham stimulation in the same patients.
- Conditions
- Neuropathic Pain, Phantom Limb Pain, Amputation
- Being tested
- Spinal anaesthesia (sub-study 1), Repetitive transcranial magnetic stimulation (sub-study 2)
- Keywords
- repetitive transcranial magnetic stimulation, spinal anaesthesia
- Medical subject headings
- Neuralgia, Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anaesthesia (sub-study 1)Drug
We will conduct two sub-studies on the same patient group. Sub-study 1 is an observational study where patients with phantom and/or residual limb pain after lower limb amputation will be given spinal anaesthesia with 1% Chloroprocaine in an open label manner to investigate whether the peripheral nervous system is a necessary driver of their pain.
Repetitive transcranial magnetic stimulation (sub-study 2)Device
After sub-study 1, the same patients will enter sub-study 2 where they are randomly assigned to receive either first active rTMS (10 days over 2 weeks), and then after a 9 week washout period, sham rTMS (10 days over 2 weeks), or they first receive sham rTMS, and then after 9 weeks of washout, active rTMS. Thus, patients undergo stimulation with deep rTMS in a double blinded randomised controlled trial with a 2 x 2 cross-over design, receiving both active and placebo stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active and then sham repetitive transcranial magnetic stimulation | Other | 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. Receives: Drug: Spinal anaesthesia (sub-study 1); Device: Repetitive transcranial magnetic stimulation (sub-study 2) |
| Sham and then active repetitive transcranial magnetic stimulation | Other | 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. Receives: Drug: Spinal anaesthesia (sub-study 1); Device: Repetitive transcranial magnetic stimulation (sub-study 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage spontaneous pain intensity reduction (sub-study 1)
Measured on an 11-point numerical rating scale (0 %= no pain reduction; 100 % = complete pain reduction).
Measured: Maximum reduction during a time interval from 5-60 minutes after spinal anaesthesia
Change in usual pain intensity over the past 24 hours from baseline to 1 week after each treatment (sub-study 2
Usual pain intensity over the past 24 hours is measured on a 11-point numerical rating scale (0 = no pain, 10 = worst pain intensity imaginable of the current pain condition) every day in a diary at the same hour (end of the day). Analgesic efficacy of active and sham treatment is considered the decrease in usual pain intensity scores between the average of each baseline week (one week before treatment) and average of 1 week after last stimulation of each treatment.
Measured: Average of usual pain scores one week before each treatment (baseline week) and 1 week after each treatment
Secondary outcomes (21)
Intensity of brush induced allodynia (sub-study 1)
Maximal pain intensity after 3 brush strokes (SOMEDIC brush) to the area of maximal pain with 2 seconds intervals and 3 cm brush strokes lasting 1 second on a 0-10 numerical rating scale (0 = no pain, 10 = worst pain imaginable)
Measured: Measured before, 5 minutes and 30 minutes after spinal anaesthesia
Intensity of pressure induced allodynia (sub-study 1)
Maximal pain intensity after 3 presses using an algometer (10 kPa) to the area of maximal pain with 2 seconds intervals lasting 10 seconds on a 0-10 numerical rating scale (0 = no pain, 10 = worst pain imaginable)
Measured: Measured before, 5 minutes and 30 minutes after spinal anaesthesia
Pin-prick sensitivity (sub-study 1)
Compared to contralateral area, sensitivity is measured with a weighted needle (512 mN) on a 0-10 numerical rating scale where 5 is normal sensation, 0 is no sensation and 10 is maximal painful/intense sensation
Measured: Measured before, 5 minutes and 30 minutes after spinal anaesthesia
Spontaneous pain intensity right now (sub-study 1)
Measured on a 0-10 numerical rating scale where 0 indicates no pain and 10 indicates worst pain imaginable
Measured: Measured before, and 5, 10, 15, 20, 25, 30, 60, 90 and 120 minutes after spinal anaesthesia
Usual pain intensity over the past 24 hours (sub-study 2)
Measured every day in a diary at the same hour (end of the day) on an 11-point numerical rating scale (0 = no pain, 10 = worst pain intensity imaginable of the current pain condition)
Measured: Analgesic efficacy of active and sham treatment is measured as the decrease in pain intensity scores between baseline values (one week before treatment) and 3 weeks after the last stimulation.
Pain intensity (sub-study 2)
Pain intensity right now, maximum and minimum pain intensity over the last 24 hours, rated on a numerical rating scale from 0 (no pain) to 10 (pain as bad as you can imagine)
Measured: Before, 1 week and 3 weeks after the end of each stimulation period
Pain unpleasantness (sub-study 2)
Pain unpleasantness right now, maximum, minimum, and usual pain unpleasantness during the last 24 hours, rated in a numerical rating scale from 0 (no pain/unpleasantness) to 10 (unpleasantness as bad as you can imagine)
Measured: Before, 1 week and 3 weeks after the end of each stimulation period
Pain diary of pain duration, paroxysms and pain interference on sleep (sub-study 2)
Pain duration (percentage wakefulness in pain on an 11-point numerical rating scale; 0% = pain and 100 % = pain all the time), number, duration and usual intensity of pain paroxysms (11-point numerical rating scale; 0 = no pain and 10 = pain as bad as you can imagine), and pain interference on sleep (11-point numerical rating scale; 0 = no interference on sleep, 10 = pain interference on sleep as bad as you can imagine)
Measured: Every day 1 week before each stimulation period and up to three weeks after
Proportion of responders (sub-study 2)
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.
Measured: Before,1 week and 3 weeks after the end of each stimulation period
Percentage pain intensity reduction (sub-study 2)
Percentage pain intensity reduction on an 11-point numerical rating scale (0 %= no pain reduction; 100% complete pain reduction)
Measured: Before,1 week and 3 weeks after the end of each stimulation period
Pain interference (sub-study 2)
7 items for pain interference on physical and psychological function from the Brief Pain Inventory rated from 0 (does not interfere), to 10 (complete interference)
Measured: Before,1 week and 3 weeks after the end of each stimulation period
Neuropathic Pain Symptom Inventory (sub-study 2)
Measures mean intensity of 10 neuropathic symptoms during the last 24 hours on 11-point (0-10) numerical scales.
Measured: Before,1 week and 3 weeks after the end of each stimulation period
Short form McGill Pain questionnaire (sub-study 2)
The sensory and affective score of the short form McGill Pain questionnaire which consists of 15 items measured on a 4 point scale.
Measured: Before,1 week and 3 weeks after the end of each stimulation period
Hospital Anxiety and Depression Scale (sub-study 2)
The Hospital Anxiety and Depression Scale includes 14 items scored as anxiety and depression scores, 7 items assessing depression and 7 anxiety
Measured: Before,1 week and 3 weeks after the end of each stimulation period
Pain Catastrophizing Scale (sub-study 2)
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).
Measured: Before,1 week and 3 weeks after the end of each stimulation period
Patient Global Impression of Change (sub-study 2)
Consists of 7 items to evaluate the subjective improvement or deterioration (from very much improved to very much deteriorated)
Measured: Before,1 week and 3 weeks after the end of each stimulation period
Insomnia Severity Index (sub-study 2)
Consists of self-rated questions which maps sleep difficulties specific to insomnia on a 5 point Likert scale
Measured: Before,1 week and 3 weeks after the end of each stimulation period
Patient-Specific Functional Scale (sub-study 2)
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)
Measured: Before,1 week and 3 weeks after the end of each stimulation period
Executive functioning using the CANTAB battery
Composite score and individual scores of the paired associates learning test, stop signal task, spatial working memory test and the multitasking test
Measured: Before,1 week and 3 weeks after the end of each stimulation period
Side-effects (sub-study 2)
Side effects using a specific side effects questionnaire specifically designed for assessment of safety in rTMS studies
Measured: Immediately after the first rTMS session for both stimulation periods, before and after all other rTMS sessions, and 1 week and 3 weeks after each stimulation period
Blinding (sub-study 2)
blinding questionnaire
Measured: 3 weeks after the end of each stimulation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Jan 2021
- Primary completion3 Dec 2021
- Study completion3 Dec 2021
Why it stopped: Recruitment and technical difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All included patients participate in sub-study 1 and 2. Sub-study 1 is an observational study where patients undergo a spinal anaesthesia in an open label manner. In sub-study 2, patients are once randomly assigned in a 1:1 ratio to one of two counterbalanced arms: either they first receive active rTMS, and then after a 9 week washout period, sham rTMS, or they first receive sham rTMS, and then after 9 weeks of washout, active rTMS. Thus, patients undergo stimulation with deep rTMS in a double blinded randomised controlled trial with a 2 x 2 cross-over design, receiving both active and placebo stimulation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine Farnes, Oslo University Hospital
- Investigators
- Audun Stubhaug, DMedSci, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819503
- Sponsor's protocol ID
- 77110
- Status last verified
- Nov 2023
- First submitted
- 16 Mar 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data collected during the trial will be available to other researchers who provide a methodologically sound proposal, and who adhere to institutional guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dependency of the Peripheral Nervous System as a Driver for Post-amputation Pain and Therapeutic Effects of Deep Repetitive Transcranial Magnetic Stimulation in a Randomized Double-blind Sham-controlled Study
- ClinicalTrials.gov ID
- NCT04819503
- Acronym / sponsor ID
- 77110
- Conditions
- Neuropathic Pain, Phantom Limb Pain, Amputation
- Keywords
- repetitive transcranial magnetic stimulation, spinal anaesthesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment and technical difficulties
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 29 Mar 2021 (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.
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 stimulation (rTMS) of the motor cortex is an increasingly studied technique for the treatment of neuropathic pain and has shown modest effects in pain intensity reduction for the treatment of neuropathic pain. Newer rTMS coils provide the opportunity to stimulate larger brain areas, which could provide a better treatment option compared to conventional coils. The aims of this study are to investigate whether the peripheral nervous system is a necessary driver of phantom limb pain and/or residual limb pain in patients with lower limb amputation using spinal anaesthesia, and to assess the analgesic efficacy of deep H-coil rTMS compared to sham stimulation in the same patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All included patients participate in sub-study 1 and 2. Sub-study 1 is an observational study where patients undergo a spinal anaesthesia in an open label manner. In sub-study 2, patients are once randomly assigned in a 1:1 ratio to one of two counterbalanced arms: either they first receive active rTMS, and then after a 9 week washout period, sham rTMS, or they first receive sham rTMS, and then after 9 weeks of washout, active rTMS. Thus, patients undergo stimulation with deep rTMS in a double blinded randomised controlled trial with a 2 x 2 cross-over design, receiving both active and placebo stimulation
| Arm | Type | Receives |
|---|---|---|
| Active and then sham repetitive transcranial magnetic stimulation | Other | Drug: Spinal anaesthesia (sub-study 1), Device: Repetitive transcranial magnetic stimulation (sub-study 2)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. |
| Sham and then active repetitive transcranial magnetic stimulation | Other | Drug: Spinal anaesthesia (sub-study 1), Device: Repetitive transcranial magnetic stimulation (sub-study 2)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
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 |
|---|---|---|
| Spinal anaesthesia (sub-study 1)We will conduct two sub-studies on the same patient group. Sub-study 1 is an observational study where patients with phantom and/or residual limb pain after lower limb amputation will be given spinal anaesthesia with 1% Chloroprocaine in an open label manner to investigate whether the peripheral nervous system is a necessary driver of their pain. | Drug | Active and then sham repetitive transcranial magnetic stimulation, Sham and then active repetitive transcranial magnetic stimulation |
| Repetitive transcranial magnetic stimulation (sub-study 2)After sub-study 1, the same patients will enter sub-study 2 where they are randomly assigned to receive either first active rTMS (10 days over 2 weeks), and then after a 9 week washout period, sham rTMS (10 days over 2 weeks), or they first receive sham rTMS, and then after 9 weeks of washout, active rTMS. Thus, patients undergo stimulation with deep rTMS in a double blinded randomised controlled trial with a 2 x 2 cross-over design, receiving both active and placebo stimulation | Device | Active and then sham repetitive transcranial magnetic stimulation, Sham and then active repetitive transcranial magnetic stimulation |
Primary outcome
Percentage spontaneous pain intensity reduction (sub-study 1)
Time frame: Maximum reduction during a time interval from 5-60 minutes after spinal anaesthesia
Measured on an 11-point numerical rating scale (0 %= no pain reduction; 100 % = complete pain reduction).
Change in usual pain intensity over the past 24 hours from baseline to 1 week after each treatment (sub-study 2
Time frame: Average of usual pain scores one week before each treatment (baseline week) and 1 week after each treatment
Usual pain intensity over the past 24 hours is measured on a 11-point numerical rating scale (0 = no pain, 10 = worst pain intensity imaginable of the current pain condition) every day in a diary at the same hour (end of the day). Analgesic efficacy of active and sham treatment is considered the decrease in usual pain intensity scores between the average of each baseline week (one week before treatment) and average of 1 week after last stimulation of each treatment.
21 secondary outcomes
Intensity of brush induced allodynia (sub-study 1)
Time frame: Measured before, 5 minutes and 30 minutes after spinal anaesthesia
Intensity of pressure induced allodynia (sub-study 1)
Time frame: Measured before, 5 minutes and 30 minutes after spinal anaesthesia
Pin-prick sensitivity (sub-study 1)
Time frame: Measured before, 5 minutes and 30 minutes after spinal anaesthesia
Spontaneous pain intensity right now (sub-study 1)
Time frame: Measured before, and 5, 10, 15, 20, 25, 30, 60, 90 and 120 minutes after spinal anaesthesia
Usual pain intensity over the past 24 hours (sub-study 2)
Time frame: Analgesic efficacy of active and sham treatment is measured as the decrease in pain intensity scores between baseline values (one week before treatment) and 3 weeks after the last stimulation.
Pain intensity (sub-study 2)
Time frame: Before, 1 week and 3 weeks after the end of each stimulation period
Pain unpleasantness (sub-study 2)
Time frame: Before, 1 week and 3 weeks after the end of each stimulation period
Pain diary of pain duration, paroxysms and pain interference on sleep (sub-study 2)
Time frame: Every day 1 week before each stimulation period and up to three weeks after
Proportion of responders (sub-study 2)
Time frame: Before,1 week and 3 weeks after the end of each stimulation period
Percentage pain intensity reduction (sub-study 2)
Time frame: Before,1 week and 3 weeks after the end of each stimulation period
Pain interference (sub-study 2)
Time frame: Before,1 week and 3 weeks after the end of each stimulation period
Neuropathic Pain Symptom Inventory (sub-study 2)
Time frame: Before,1 week and 3 weeks after the end of each stimulation period
Short form McGill Pain questionnaire (sub-study 2)
Time frame: Before,1 week and 3 weeks after the end of each stimulation period
Hospital Anxiety and Depression Scale (sub-study 2)
Time frame: Before,1 week and 3 weeks after the end of each stimulation period
Pain Catastrophizing Scale (sub-study 2)
Time frame: Before,1 week and 3 weeks after the end of each stimulation period
Patient Global Impression of Change (sub-study 2)
Time frame: Before,1 week and 3 weeks after the end of each stimulation period
Insomnia Severity Index (sub-study 2)
Time frame: Before,1 week and 3 weeks after the end of each stimulation period
Patient-Specific Functional Scale (sub-study 2)
Time frame: Before,1 week and 3 weeks after the end of each stimulation period
Executive functioning using the CANTAB battery
Time frame: Before,1 week and 3 weeks after the end of each stimulation period
Side-effects (sub-study 2)
Time frame: Immediately after the first rTMS session for both stimulation periods, before and after all other rTMS sessions, and 1 week and 3 weeks after each stimulation period
Blinding (sub-study 2)
Time frame: 3 weeks after the end of each stimulation period
Results and safety
The study was stopped early (reason given: Recruitment and technical difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data collected during the trial will be available to other researchers who provide a methodologically sound proposal, and who adhere to institutional guidelines.
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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.
Audun Stubhaug, DMedSci study director
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal anaesthesia (sub-study 1) and Repetitive transcranial magnetic stimulation (sub-study 2) in people with Neuropathic Pain and Phantom Limb Pain, run by Oslo University Hospital at 1 site in Norway.
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 8 inclusion and 9 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: stopped early, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Recruitment and technical difficulties). 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?
Percentage spontaneous pain intensity reduction (sub-study 1) (time frame: Maximum reduction during a time interval from 5-60 minutes after spinal anaesthesia). 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 29 Nov 2023.