Personalized Treatment by rTMS in Chronic Pain - Study2
ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAalborg University
About this trial
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 analysing brain signal measurements before the start of the therapy and adjusting/personalizing the magnetic stimulations to each individual person.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
rTMS to M1
Device• 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. All patients will receive 14 sessions of rTMS.
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: Classical rTMS to M1Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain intensity (Visual analogue scale)
The '0' represents 'no pain' at all, and '100' represents the 'worst possible pain' that the individual can imagine.
Time frame
VAS will be assessed before treatment and post intervention. Responders are those with ≥30% pain reduction, based on the difference in VAS the last 24 hours at the end of maintenance compared to average pain intensity the week before baseline assessment.Secondary outcomes
1
Patients' Global Impression of Change
The questionnaire assesses the individual's impression of change after an intervention. The Likert scale is asking whether 'After the beginning of this study, my overall state of health is': with the options of 'Very much improved', 'Much improved', 'Minimally improved', 'No change', 'Minimally worse', 'Much worse'.
Time frame
Patients' Global Impression of Change will be investigated before the treatment, at the end of the course of treatment (8 weeks of treatment), and again after 3 months following the end of treatment.2
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. Items such as pain severity and Pain Interference Score can be calculated as well as number of affected body areas.
Time frame
Short Brief Pain Inventory changes will be investigated before the treatment, at the end of the course of treatment (8 weeks of treatment), and again after 3 months following the end of treatment.3
Short McGill Pain Questionnaire
A comprehensive multidimensional tool that assesses the three main aspects of pain: sensory discriminative, affective-motivational, and cognitive-evaluative. Words describing pain is presented and the patient has to choose whether it is recognisable in mild, moderate or severe way and it has the option of 'none'.
Time frame
Short McGill Pain Questionnaire changes will be investigated before the treatment, at the end of the course of treatment (8 weeks of treatment), and again after 3 months following the end of treatment.4
Quality of sleep (VAS)
A VAS scale to determine 'how did you sleep last night' ranging from 0 ('poor') to 10 ('great').
Time frame
Sleep VAS changes will be investigated before the treatment, at the end of the course of treatment (8 weeks of treatment), and again after 3 months following the end of treatment.Sponsors and contacts
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Source ClinicalTrials.gov