Pain
Conditions
Interventions
This study is part of a larger project evaluating patients with chronic pain, neuropathic pain, and migraine. This specific part focuses on patients with peripheral neuropathic pain.In a subgroup, par
and the I group received rTMS in the posterior superior insula region (T7 and T8 regions) at 10Hz, 3000 pulses, 80% of motor threshold, using a double-cone coil. Stimulation was contralateral to the p
Global Impression of Change (GIC)
Neuropathic Pain Symptom Inventory (NPSI)
EuroQoL-5D Quality of Life Questionnaire
McGill Pain Questionnaire (affective dimension of pain)
Numerical Rating Scale for pain, anxiety, depression, sleep disturbance, and fatigue
Visceral sensitivity questionnaire (interoception). EMTr was administered in daily induction sessions for 5 days, followed by maintenance sessions with stimulation once a week for an add
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Sponsors
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 18 years of age or older. Both gender. Ability to understand the study protocol and provide written informed consent. For patients with neuropathic pain, presence of peripheral neuropathic pain, according to current guidelines, with the following characteristics: Average pain intensity assessed by the Verbal Numeric Rating Scale = 4/10. Presence of neuropathic pain refractory to medication therapy. Persistent for more than six (6) months. For patients with migraine: Diagnosis of migraine with or without aura, according to the 3rd edition of the International Classification of Headache Disorders, in addition to the following characteristics: onset of migraine before 65 years of age, monthly frequency of headache days =4, absence of any secondary headache diagnosis, according to the 3rd edition of the International Classification of Headache Disorders, and no modifications to their migraine prophylactic treatment in the last 3 months
Exclusion criteria
Exclusion criteria: History of alcohol or illicit drug abuse. Severe uncompensated psychiatric comorbidities Comorbidities: Severe uncompensated medical comorbidities. Contraindications to rTMS, including cranial trauma or concussion, metallic implants in the skull, pregnancy, pacemaker, medication infusion devices, prior problems with TMS or MRI. Women of childbearing potential who are not using effective contraceptive methods. Other medical conditions that require hospitalization. Participation in other clinical trials at the same time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For patients with neuropathic pain,responder rate (30% reduction in mean pain intensity at the last visit compared to pretreatment baseline values) on the BPI scale.;For patients with migraine, Monthly frequency of headache days during weeks 9 through 12 of treatment;For patients with migraine, responder rate, who experienced a = 50% reduction in monthly headache day frequency, in the 9th to 12th week of treatment compared to the month prior to the start of the study (baseline period) | — |
Secondary
| Measure | Time frame |
|---|---|
| For patients with neuropathic pain, pain intensity (0 to 10 verbal numerical scale) after induction (day 5) and after the twelfth (12th) week of treatment, maintenance phase;For patients with neuropathic pain, number of responders (50% reduction) in the Brief Pain Inventory assessment at the end of the stimulation period (12th week), compared to baseline values;For patients with neuropathic pain, evaluation of neuropathic pain symptoms using the Neuropathic Pain Symptom Inventory (NPSI) after induction (day 5) and after the twelfth (12th) week of treatment, maintenance phase;For patients with migraine, monthly frequency of days of acute headache medication use ;For patients with migraine, HIT6 score at week 12;For patients with migraine, the Migraine Disability Assessment Test (MIDAS) score at week 12;For patients with migraine, the Migraine-Specific Quality of Life Questionnaire (MSQoL v2.1) score at week 12 | — |
Countries
Brazil
Contacts
Public ContactTamara Maria Pereira
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed