Chronic PainPersoNINpainNCT06395649
Personalized Treatment by rTMS in Chronic Pain
A study testing Classical rTMS to M1, rTMS to the High connectivity target and rTMS to the low connectivity target in people with Chronic Pain, run by Aalborg University at 1 site in Denmark.
Trial summary
Previous research has shown the effectiveness of magnetic stimulation of the brain as a supplemental treatment for various conditions, such as depression and chronic pain. However, the application of magnetic stimulation has been standardized across patients without considering individual differences. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Classical rTMS to M1, rTMS to the High connectivity target and rTMS to the low connectivity target
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 15 May 2024to 31 May 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of chronic pain (present most of the days for more than 3 months).
- Pain with a mean pain intensity between 3-9 on a 0-10 pain scale (where 0 means no pain and 10 means the worst pain imaginable).
- Speak and understand English or Danish
Who cannot join
- Pregnant or breastfeeding
- Current uncontrolled major depression as the main diagnosis
- Current history of substance abuse
- Lack of ability to cooperate, to fully understand the protocol or any difficulty in filling out questionnaires (e.g., due to language or cognitive problems)
- Formal contraindications to TMS application (presence of epilepsy, cranial implanted ferromagnetic devices, e.g., intracranial neurostimulator or cochlear implants, tattoos with metal ink on the face or permanent make up with metal in the face )16
- Unable to answer the "Transcranial Magnetic Stimulation Adult Safety Screen" screening questionnaire.
- Participation in other research protocols within 1 month before the inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Pain Treatment by Transcranial Magnetic Stimulation in Patients With Chronic Pain: a Study on Mechanisms
Previous research has shown the effectiveness of magnetic stimulation of the brain as a supplemental treatment for various conditions, such as depression and chronic pain. However, the application of magnetic stimulation has been standardized across patients without considering individual differences. This one-size-fits-all approach results in only half of the patients benefiting from the treatment, with the other half seeing no improvement in their symptoms. Therefore, a study on individuals with chronic pain will be performed to explore how magnetic stimulation treatments can be tailored to each person. This will involve analyzing brain signal measurements before the start of the therapy and adjusting/personalizing the magnetic stimulations to each individual person.
Read the detailed description
This project aims to test if the effects of non-pharmacological, non-invasive pain treatment can be enhanced by employing brain connectivity information to guide the application of repetitive transcranial magnetic stimulation (rTMS). Previous efficacy and safety trials have supported that rTMS for pain relief is applied to four main cortical areas: primary motor cortex (M1), dorsolateral prefrontal cortex (DLPFC), anterior cingulate cortex (ACC), and posterosuperior insular (PSI). However, some patients respond to rTMS to one of these targets but not to the others. Since there is no current strategy to know which patient will respond to each treatment target, patients with chronic pain end up undergoing trial and error strategies, which delay their improvement. This is actually not different from challenges related to pharmacological treatment, where each medication only relieves pain in 30-40% of patients, and the choice of each medication is based on "trial-and-error basis".
Several strategies currently aim to provide a more individualized strategy for choosing analgesic interventions based on patient-related information. In order to allow for the design of efficacy trials in the future, the present project is based on a proof-of-concept, mechanistic design. It will employ rTMS stimulation for pain control, but the choice of each of the stimulation targets will be made based on each individual's brain signals as read by EEG recorded before the start of the treatment. Therefore, before receiving a full rTMS treatment, patients will undergo a neurophysiological screening session using single-pulseTMS-EEG. Single-pulseTMS and EEG have been routinely used in the clinic as a part of the neurophysiological assessment of patients for decades but have not yet been used in the association as an attempt to try to guide the choice of treatment. In the screening session, single pulses TMS will be applied to each of the primary network hubs used in therapeutic rTMS: M1, DLPFC, ACC, and PSI. Concomitantly, the EEG oscillatory activity of these four cortical areas will be recorded, and the brain connectivity state will be assessed. By using information derived from a patient´s brain connectivity state using transcranial magnetic stimulation with electroencephalography (TMS-EEG), the most appropriate of the four classic targets will be selected and used in rTMS on an individualized basis. It is hypothesized that the brain regions with low local-to-global connectivity will provide better pain relief compared to non-personalized treatment approaches and compared to targets with optimized local-to-global connectivity status.
A total of 90 subjects with chronic pain will be included in a double-blind, randomized three parallel-arm study comparing the analgesic effect of the therapeutic rTMS target chosen based on TMS-EEG:
- target area presenting the lowest local-to-global connectivity
- target area presenting the highest local-to-global connectivity
- classic M1 stimulation.
The subjects will be allocated in a 1:1:1 ratio to one of three arms (30 subjects per arm). The protocol is designed as an adaptive study, incorporating interim analyses after enrolling 30 and 60 subjects. These evaluations, conducted by a blinded specialist statistician panel, will assess the efficacy of the target selection strategy for each arm, focusing on the primary outcome's progression.
In the initial baseline measurement, the subjects will fill out questionnaires and undergo neurophysiological assessments. After this baseline measurement, the subjects will be assigned to one of the three arms and will receive daily rTMS sessions targeting areas (called induction phase) for 5 consecutive days (Monday to Friday) with either "high connectivity", "low connectivity", or a "classic M1 target". Each of the 5 daily stimulations will last 30 minutes, of which 15 minutes will be under treatment.
The induction phase will be followed by a 6-week maintenance phase, with 1 rTMS session per week (totaling 6 rTMS sessions). At the end of the maintenance phase, primary and secondary outcomes (questionnaires) will be collected to investigate the efficacy of the rTMS treatments. A random subsample of 30 participants (10 from each arm) will be asked if they would like to participate in a second 3-hour neurophysiological assessment to investigate the changes in brain connectivity.
Subjects experiencing significant pain reduction (according to the primary outcome) by the treatment will be asked if they would like to continue maintenance stimulation sessions. Participants accepted to join this part of the study will receive 1 stimulation session every 2 weeks for 4 weeks (total of 2 stimulation sessions). The participants will receive either active stimulation exactly as they received previously or sham stimulation with rTMS in a double-blind, randomized, placebo-controlled, two-group setup. After the extended maintenance phase, primary and secondary outcomes (questionnaires) will be issued, and a random subsample of 20 patients (10 per group) will go through a third, 3-hour-long assessment involving neurophysiological assessment to investigate the changes in connectivity.
When 50% of inclusion is completed, a preplanned interim futility analysis is scheduled to examine safety and the main outcome.
- Conditions
- Chronic Pain
- Being tested
- Classical rTMS to M1, rTMS to the High connectivity target, rTMS to the low connectivity target, Sham rTMS
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classical rTMS to M1Device
The rTMS intervention consists of 10-Hz rTMS. Thirty trains of ten seconds with an interval of twenty seconds between trains will be delivered, as traditionally performed. Each train includes 100 pulses, and the total number of pulses will be 3,000 given in 15 minutes.
rTMS to the High connectivity targetDevice
The rTMS intervention consists of 10-Hz rTMS. Thirty trains of ten seconds will be delivered with an interval of twenty seconds between trains. Each train includes 100 pulses, and the total number of pulses will be 3,000 given in 15 minutes. The rTMS will be delivered to the target, showing the highest connectivity.
rTMS to the low connectivity targetDevice
The rTMS intervention consists of 10-Hz rTMS. Thirty trains of ten seconds with an interval of twenty seconds between trains will be delivered. Each train includes 100 pulses, and the total number of pulses will be 3,000 given in 15 minutes. The rTMS will be delivered to the target, showing the lowest connectivity.
Sham rTMSDevice
Sham stimulation was carried out with a sham coil of identical size, color, and shape, emitting a sound similar to that emitted by the active coil.
| Study group | Role | What they receive |
|---|---|---|
| Classical rTMS to M1x | Active comparator | The patients will receive repetitive transcranial magnetic stimulation (rTMS) to the primary cortex (M1) according to the classical treatment. Receives: Device: Classical rTMS to M1 |
| High connectivity target | Experimental | The patients will receive repetitive transcranial magnetic stimulation (rTMS) to target showing the largest connectivity during the TMS-EEG assessment one week before starting the treatment Receives: Device: rTMS to the High connectivity target |
| Low connectivity target | Experimental | The patients will receive repetitive transcranial magnetic stimulation (rTMS) to target showing the lowest connectivity during the TMS-EEG assessment one week before starting the treatment Receives: Device: rTMS to the low connectivity target |
| Sham stimulation | Sham comparator | Subjects experiencing significant pain reduction (according to the primary outcome) by the treatment will be asked if they would like to continue maintenance stimulation sessions. Participants accepted to join this part of the study will receive 1 stimulation session every 2 weeks for 4 weeks (total of 2 stimulation sessions). The participants will receive either active stimulation exactly as they received previously or sham stimulation with rTMS in a double-blind, randomized, placebo-controlled, two-group setup. Receives: Device: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (Visual analogue scale)
The '0' represents 'no pain' at all, and '100' represents the 'worst possible pain' that the individual can imagine.
Measured: VAS will be assessed before treatment, after 2 months, and again after 3 months. Responders are those with ≥30% pain reduction at the end of maintenance compared to average pain intensity the week before baseline assessment.
Secondary outcomes (5)
Quality of life (EQ-5D)
EQ-5D is a standardized measure of health-related quality of life
Measured: Quality of life changes will be investigated before the treatment, immediately after 2 months of treatment, and again after 3 months of treatment.
Patients' Global Impression of Change
The questionnaire assesses the individual's impression of change after an intervention.
Measured: Patients' Global Impression of Change will be investigated before the treatment, immediately after 2 months of treatment, and again after 3 months of treatment.
Short Brief Pain Inventory
9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning.
Measured: Short Brief Pain Inventory changes will be investigated before the treatment, immediately after 2 months of treatment, and again after 3 months of treatment.
Short McGill Pain Questionnaire
a comprehensive multidimensional tool that assesses the three main aspects of pain: sensory discriminative, affective-motivational, and cognitive-evaluative
Measured: Short McGill Pain Questionnaire changes will be investigated before the treatment, immediately after 2 months of treatment, and again after 3 months of treatment.
Connectivity analysis
Electroencephalography (EEG) recorded during single pulses of TMS will be used to evaluate brain connectivity.
Measured: Connectivity changes will be investigated before the treatment, immediately after 2 months of treatment, and again after 3 months of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start15 May 2024
- Primary completion1 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- When 50% of inclusion is completed, a preplanned interim futility analysis is scheduled to examine safety and the main outcome.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico De Martino, Aalborg University
- Investigators
- Enrico De Martino, Dr, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395649
- Sponsor's protocol ID
- N-20230076
- Acronym
- PersoNINpain
- Status last verified
- May 2026
- First submitted
- 29 Apr 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Martino E, Nascimento Couto B, Midtgaard Bach M, Jakobsen A, Ingemann-Molden S, Casali A, Graven-Nielsen T, Ciampi de Andrade D. Patients with different putative chronic pain mechanisms have different cortical complexity and synchrony. Pain. 2026 Aug 1;167(8):1920-1931. doi: 10.1097/j.pain.0000000000004015. Epub 2026 May 18.
PubMed 42152687
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Pain Treatment by Transcranial Magnetic Stimulation in Patients With Chronic Pain: a Study on Mechanisms
- ClinicalTrials.gov ID
- NCT06395649
- Acronym / sponsor ID
- PersoNINpain / N-20230076
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 2 May 2024 (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.
Previous research has shown the effectiveness of magnetic stimulation of the brain as a supplemental treatment for various conditions, such as depression and chronic pain. However, the application of magnetic stimulation has been standardized across patients without considering individual differences. This one-size-fits-all approach results in only half of the patients benefiting from the treatment, with the other half seeing no improvement in their symptoms. Therefore, a study on individuals with chronic pain will be performed to explore how magnetic stimulation treatments can be tailored to each person. This will involve analyzing brain signal measurements before the start of the therapy and adjusting/personalizing the magnetic stimulations to each individual person.
Detailed description
This project aims to test if the effects of non-pharmacological, non-invasive pain treatment can be enhanced by employing brain connectivity information to guide the application of repetitive transcranial magnetic stimulation (rTMS). Previous efficacy and safety trials have supported that rTMS for pain relief is applied to four main cortical areas: primary motor cortex (M1), dorsolateral prefrontal cortex (DLPFC), anterior cingulate cortex (ACC), and posterosuperior insular (PSI). However, some patients respond to rTMS to one of these targets but not to the others. Since there is no current strategy to know which patient will respond to each treatment target, patients with chronic pain end up undergoing trial and error strategies, which delay their improvement. This is actually not different from challenges related to pharmacological treatment, where each medication only relieves pain in 30-40% of patients, and the choice of each medication is based on "trial-and-error basis".
Several strategies currently aim to provide a more individualized strategy for choosing analgesic interventions based on patient-related information. In order to allow for the design of efficacy trials in the future, the present project is based on a proof-of-concept, mechanistic design. It will employ rTMS stimulation for pain control, but the choice of each of the stimulation targets will be made based on each individual's brain signals as read by EEG recorded before the start of the treatment. Therefore, before receiving a full rTMS treatment, patients will undergo a neurophysiological screening session using single-pulseTMS-EEG. Single-pulseTMS and EEG have been routinely used in the clinic as a part of the neurophysiological assessment of patients for decades but have not yet been used in the association as an attempt to try to guide the choice of treatment. In the screening session, single pulses TMS will be applied to each of the primary network hubs used in therapeutic rTMS: M1, DLPFC, ACC, and PSI. Concomitantly, the EEG oscillatory activity of these four cortical areas will be recorded, and the brain connectivity state will be assessed. By using information derived from a patient´s brain connectivity state using transcranial magnetic stimulation with electroencephalography (TMS-EEG), the most appropriate of the four classic targets will be selected and used in rTMS on an individualized basis. It is hypothesized that the brain regions with low local-to-global connectivity will provide better pain relief compared to non-personalized treatment approaches and compared to targets with optimized local-to-global connectivity status.
A total of 90 subjects with chronic pain will be included in a double-blind, randomized three parallel-arm study comparing the analgesic effect of the therapeutic rTMS target chosen based on TMS-EEG:
- target area presenting the lowest local-to-global connectivity
- target area presenting the highest local-to-global connectivity
- classic M1 stimulation.
The subjects will be allocated in a 1:1:1 ratio to one of three arms (30 subjects per arm). The protocol is designed as an adaptive study, incorporating interim analyses after enrolling 30 and 60 subjects. These evaluations, conducted by a blinded specialist statistician panel, will assess the efficacy of the target selection strategy for each arm, focusing on the primary outcome's progression.
In the initial baseline measurement, the subjects will fill out questionnaires and undergo neurophysiological assessments. After this baseline measurement, the subjects will be assigned to one of the three arms and will receive daily rTMS sessions targeting areas (called induction phase) for 5 consecutive days (Monday to Friday) with either "high connectivity", "low connectivity", or a "classic M1 target". Each of the 5 daily stimulations will last 30 minutes, of which 15 minutes will be under treatment.
The induction phase will be followed by a 6-week maintenance phase, with 1 rTMS session per week (totaling 6 rTMS sessions). At the end of the maintenance phase, primary and secondary outcomes (questionnaires) will be collected to investigate the efficacy of the rTMS treatments. A random subsample of 30 participants (10 from each arm) will be asked if they would like to participate in a second 3-hour neurophysiological assessment to investigate the changes in brain connectivity.
Subjects experiencing significant pain reduction (according to the primary outcome) by the treatment will be asked if they would like to continue maintenance stimulation sessions. Participants accepted to join this part of the study will receive 1 stimulation session every 2 weeks for 4 weeks (total of 2 stimulation sessions). The participants will receive either active stimulation exactly as they received previously or sham stimulation with rTMS in a double-blind, randomized, placebo-controlled, two-group setup. After the extended maintenance phase, primary and secondary outcomes (questionnaires) will be issued, and a random subsample of 20 patients (10 per group) will go through a third, 3-hour-long assessment involving neurophysiological assessment to investigate the changes in connectivity.
When 50% of inclusion is completed, a preplanned interim futility analysis is scheduled to examine safety and the main outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- When 50% of inclusion is completed, a preplanned interim futility analysis is scheduled to examine safety and the main outcome.
| Arm | Type | Receives |
|---|---|---|
| Classical rTMS to M1x | Active comparator | Device: Classical rTMS to M1The patients will receive repetitive transcranial magnetic stimulation (rTMS) to the primary cortex (M1) according to the classical treatment. |
| High connectivity target | Experimental | Device: rTMS to the High connectivity targetThe patients will receive repetitive transcranial magnetic stimulation (rTMS) to target showing the largest connectivity during the TMS-EEG assessment one week before starting the treatment |
| Low connectivity target | Experimental | Device: rTMS to the low connectivity targetThe patients will receive repetitive transcranial magnetic stimulation (rTMS) to target showing the lowest connectivity during the TMS-EEG assessment one week before starting the treatment |
| Sham stimulation | Sham comparator | Device: Sham rTMSSubjects experiencing significant pain reduction (according to the primary outcome) by the treatment will be asked if they would like to continue maintenance stimulation sessions. Participants accepted to join this part of the study will receive 1 stimulation session every 2 weeks for 4 weeks (total of 2 stimulation sessions). The participants will receive either active stimulation exactly as they received previously or sham stimulation with rTMS in a double-blind, randomized, placebo-controlled, two-group setup. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of chronic pain (present most of the days for more than 3 months).
- Pain with a mean pain intensity between 3-9 on a 0-10 pain scale (where 0 means no pain and 10 means the worst pain imaginable).
- Speak and understand English or Danish
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding
- Current uncontrolled major depression as the main diagnosis
- Current history of substance abuse
- Lack of ability to cooperate, to fully understand the protocol or any difficulty in filling out questionnaires (e.g., due to language or cognitive problems)
- Formal contraindications to TMS application (presence of epilepsy, cranial implanted ferromagnetic devices, e.g., intracranial neurostimulator or cochlear implants, tattoos with metal ink on the face or permanent make up with metal in the face )16
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 |
|---|---|---|
| Classical rTMS to M1The rTMS intervention consists of 10-Hz rTMS. Thirty trains of ten seconds with an interval of twenty seconds between trains will be delivered, as traditionally performed. Each train includes 100 pulses, and the total number of pulses will be 3,000 given in 15 minutes. | Device | Classical rTMS to M1x |
| rTMS to the High connectivity targetThe rTMS intervention consists of 10-Hz rTMS. Thirty trains of ten seconds will be delivered with an interval of twenty seconds between trains. Each train includes 100 pulses, and the total number of pulses will be 3,000 given in 15 minutes. The rTMS will be delivered to the target, showing the highest connectivity. | Device | High connectivity target |
| rTMS to the low connectivity targetThe rTMS intervention consists of 10-Hz rTMS. Thirty trains of ten seconds with an interval of twenty seconds between trains will be delivered. Each train includes 100 pulses, and the total number of pulses will be 3,000 given in 15 minutes. The rTMS will be delivered to the target, showing the lowest connectivity. | Device | Low connectivity target |
| Sham rTMSSham stimulation was carried out with a sham coil of identical size, color, and shape, emitting a sound similar to that emitted by the active coil. | Device | Sham stimulation |
Primary outcome
Pain intensity (Visual analogue scale)
Time frame: VAS will be assessed before treatment, after 2 months, and again after 3 months. Responders are those with ≥30% pain reduction at the end of maintenance compared to average pain intensity the week before baseline assessment.
The '0' represents 'no pain' at all, and '100' represents the 'worst possible pain' that the individual can imagine.
5 secondary outcomes
Quality of life (EQ-5D)
Time frame: Quality of life changes will be investigated before the treatment, immediately after 2 months of treatment, and again after 3 months of treatment.
Patients' Global Impression of Change
Time frame: Patients' Global Impression of Change will be investigated before the treatment, immediately after 2 months of treatment, and again after 3 months of treatment.
Short Brief Pain Inventory
Time frame: Short Brief Pain Inventory changes will be investigated before the treatment, immediately after 2 months of treatment, and again after 3 months of treatment.
Short McGill Pain Questionnaire
Time frame: Short McGill Pain Questionnaire changes will be investigated before the treatment, immediately after 2 months of treatment, and again after 3 months of treatment.
Connectivity analysis
Time frame: Connectivity changes will be investigated before the treatment, immediately after 2 months of treatment, and again after 3 months of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Derived from this study: PubMed 42152687De Martino E, Nascimento Couto B, Midtgaard Bach M, Jakobsen A, Ingemann-Molden S, Casali A, Graven-Nielsen T, Ciampi de Andrade D. Patients with different putative chronic pain mechanisms have different cortical complexity and synchrony. Pain. 2026 Aug 1;167(8):1920-1931. doi: 10.1097/j.pain.0000000000004015. Epub 2026 May 18.
- Individual participant dataSharing planned: No
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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.
Enrico De Martino, Dr principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classical rTMS to M1, rTMS to the High connectivity target and rTMS to the low connectivity target in people with Chronic Pain, run by Aalborg University at 1 site in Denmark.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 2 Jun 2026. 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 Denmark. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain intensity (Visual analogue scale) (time frame: VAS will be assessed before treatment, after 2 months, and again after 3 months. Responders are those with ≥30% pain reduction at the end of maintenance compared to average pain intensity the week before baseline assessment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06395649, which also lists 1 linked publication.
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 2 Jun 2026.