Neuropathic pain is a common complication after spinal cord injury (SCI), which significantly affects the patient's quality of life and may be resistant to pharmacological treatment. In our study, we aimed to evaluate the efficacies of intermittent theta burst (iTBS) and high frequency (10 Hz) repetitive transcranial magnetic stimulation (rTMS) by comparing them with each other and with sham stimulation, in the treatment of neuropathic pain resistant to pharmacological treatment in patients with SCI. Question 1: İs rTMS anda iTBS treatment, useful for pain severity and the effect of pain on daily functions, in the treatment of neuropathic pain in SCI Question 2: Are rTMS and iTBS treatments effective in depression in patients with neuropathic pain after spinal cord injury?
Pharmacological treatments may be insufficient to limit neuropathic pain. Therefore, research continues for safe and effective new treatments. Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation method that modulates the cortical excitability of the motor area to which it is applied. Theta Burst stimulation (TBS) is a new rTMS method consisting of stimulation sequences in a special pattern. It stands out with its ability to deliver high pulses in a short time and its high capacity to induce cortical plasticity. Intermittent TBS (iTBS) and high frequency rTMS facilitate excitability in the motor area where it is applied, and this effect is used in pain treatment. Pain modulation with these methods has been tried in some studies. Therefore, repetitive magnetic stimulation of the motor cortex by these two methods may be good options for the treatment of neuropathic pain resistant to pharmacological treatment in patients with SCI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
For TMS, the Magstim Rapid2 Magnetic Stimulator (Magstim, Whitland, Dyfed, UK) device, available in our center, was used.
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye)
Change in pain severity and pain interference assessed using the Brief Pain Inventory-Short Form (BPI-SF)
Brief Pain Inventory-Short Form (BPI-SF) is designed to assess pain in sensory (pain intensity and severity) and reactive dimensions (impact on daily functioning). The BPI-SF consists of two sections. The first section evaluates the intensity of worst, least, average, and current pain using a numerical rating scale (NRS; 0-10). A response of 0 indicates no pain at all quot; and a response of 10 indicates pain as bad as you can imagine. The second section consists of seven questions that assess the impact of pain on general activity, mood, work, walking ability, sleep, relationships with others, and enjoyment of life. Responses are rated on a scale of 0 to 10. A response of 0 in the second section indicates 'does not interfere' and a response of 10 indicates 'completely interferes'. The second section total score is calculated by summing the scores of the seven questions, resulting in a score out of 70. The total score ranges from 0 to 70.
Time frame: Patients were evaluated with BPI-SF before the treatment, at the end of the treatment (within the first 24 hours after the 10th session) and 4 weeks after the end of the treatment.
Change in depression severity assessed using the Beck Depression Inventory (BDI)
The Beck Depression Inventory (BDI) is one of the most commonly used self-assessment scales to determine the level of depression. It consists of 21 items, each containing 4 options that indicate the level of the individual\'s mood. The patient selects the most appropriate expression for themselves. Each option is scored from 0 to 3, with 0 indicating the mildest and 3 indicating the most severe symptom. The scores from the 21 questions are added up to calculate the total score. The total score ranges from 0 to 63. It is classified as minimal (0-13), mild (14-19), moderate (20-28), and severe (29-63) depression. The Turkish validity and reliability of the scale were conducted. In this study, the BDI was used to assess the level of depression in patients with SCI.
Time frame: Patients were evaluated with BDI before the treatment, at the end of the treatment and 4 weeks after the end of the treatment.
Patient-reported treatment satisfaction assessed using a 5-point Likert scale (1 = not satisfied at all, 5 = very satisfied)
Patient satisfaction with treatment was evaluated using a 5-point Likert scale. 1 represented 'not satisfied at all' and 5 represented very satisfied.
Time frame: It was administered immediately after the end of treatment and 4 weeks after the end of treatment.
Treatment-related discomfort assessed using a 10-cm Visual Analog Scale (VAS; 0 = no discomfort, 10 = worst imaginable discomfort)
4.The level of discomfort caused by the treatment was evaluated using the Visual Analog Scale (VAS). In this scale, the two ends of a 10 cm line are labeled with the extreme descriptions of the parameter to be evaluated. Although this scale is commonly used for pain assessment, it was used in our study to assess the level of discomfort. The scale ranges from 0 (no discomfort) to 10 (the most severe discomfort the patient has ever experienced in their life), and the patient is asked to mark the region that corresponds to their current condition. The distance of the marked point from the 0 point determines the patient level of discomfort.
Time frame: It was administered immediately after the end of treatment.
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