Trial of long-term rTMS therapy for intractable neuropathic pain

Authors [No authors listed]
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2020
Links jRCT, ICTRP
INTERVENTION: repetitive transcranial magnetic stimulation CONDITION: neuropathic pain ; chronic pain, intractable pain PRIMARY OUTCOME: Decrease in the weekly average of pain diary (NRS) at each week (week 1 to 8) compared with baseline INCLUSION CRITERIA: 1) Patients with neuropathic pain longer than 6 months after onset. 2) Baseline VAS of pain intensity: 40 to 95/100 mm 3) Patients with currently prescribed medication for NP or a history of being prescribed multiple medications for NP without achieving pain control 4) Patients with continuous pain at upper extremity 5) Age >= 20 years 6) Patients with written consent for participation in this study 1) Average of pain diary (NRS) 1 week before intervention: >= 4 2) Average of VAS 1 week before intervention: >= 40 mm SECONDARY OUTCOME: 1) Pain diary; Decrease rate of the weekly average of pain diary (NRS) at each time point compared with baseline; Ratio of patients that showed >= 2 decrease in the weekly average of pain diary (NRS) at week 8; Ratio of patients that showed >= 4 decrease in the weekly average of pain diary (NRS) at week 8; Ratio of patients that showed >= 30% decrease in the weekly average of pain diary (NRS) at week 8; Ratio of patients that showed >= 50% decrease in the weekly average of pain diary (NRS) at week 8; 2) VAS; Decrease and decrease rate of VAS at each time point compared with baseline; Ratio of patients that showed >= 20 mm decrease in VAS at week 9; Ratio of patients that showed >= 40 mm decrease in VAS at week 9; Ratio of patients that showed >= 30% decrease in VAS at week 9; Ratio of patients that showed >= 50% decrease in VAS at week 9; 3) SF‐MPQ2; Decrease and decrease rate of SF‐MPQ2 total score at each time point compared with baseline; Ratio of patients that showed >= 30% decrease in SF‐MPQ2 total score at week 9; Ratio of patients that showed >= 50% decrease in SF‐MPQ2 total score at week 9; Decrease and decrease rate of SF‐MPQ2 each subscale score (continuous pain, intermittent pain, neuropathic pain, affective descriptors) at each time point compared with baseline; Ratio of patients that showed >= 30% decrease in SF‐MPQ2 each subscale score at week 9; Ratio of patients that showed >= 50% decrease in SF‐MPQ2 each subscale score at week 9; Decrease and decrease rate of SF‐MPQ2 each item at each time point compared with baseline; Ratio of patients that showed >= 30% decrease in SF‐MPQ2 each item at week 9; Ratio of patients that showed >= 50% decrease in SF‐MPQ2 each item at week 9; 4) VAS immediately after intervention; Decrease and decrease rate of VAS immediately after each intervention compared with baseline; Decrease and decrease rate of VAS immediately after intervention during induction period (day 1 to 5) compared with baseline; Ratio of patients that showed >= 10 mm decrease in VAS immediately after intervention during induction period (day 1 to 5); Ratio of patients that showed >= 20 mm decrease in VAS immediately after intervention during induction period (day 1 to 5); Ratio of patients that showed >= 10% decrease in VAS immediately after intervention during induction period (day 1 to 5); Ratio of patients that showed >= 15% decrease in VAS immediately after intervention during induction period (day 1 to 5); Ratio of patients that showed >= 30% decrease in VAS immediately after intervention during induction period (day 1 to 5); 5) PGIC; PGIC at each time point; Ratio of patients that showed >= "minimally improved" in PGIC at each time point; Ratio of patients that showed >= "much improved" in PGIC at each time point; 6) PCS; Decrease in PCS at week 9 compared with baseline; Decrease in PCS each subscale score (rumination, helplessness, magnification) at week 9 compared with baseline; 7) PDAS; Decrease in PDAS at week 9 compared with baseline; 8) EQ‐5D‐5L; Increase in the QOL value of EQ‐5D‐5L at week 9 compared with baseline; 9) BDI‐II; Decrease in BDI‐II at week 9 compared with baseline; Ratio of patients that showed >= 5 decrease in BDI‐II at week 9; 10) MMSE; Increase in MMSE at week 9 compared with baseline; 11) Safety; Adverse event; 12) Blinding assessment; Ratio of patient's guess of assigned intervention at week 9
Epistemonikos ID: 69e0ba8fba6a3b2fa774e806cc25e95e391f2493
First added on: Aug 24, 2024