Clinical Efficacy of Neurotropin for Lumbar Spinal Stenosis with Low Back Pain

Autor: Yawara Eguchi, Yasuchika Aoki, Masaomi Yamashita, Kazuki Fujimoto, Takashi Sato, Koki Abe, Masashi Sato, Hajime Yamanaka, Toru Toyoguchi, Keisuke Shimizu, Sumihisa Orita, Kazuhide Inage, Yasuhiro Shiga, Seiji Ohtori
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Pain and Therapy, Vol 12, Iss 2, Pp 461-473 (2023)
Druh dokumentu: article
ISSN: 2193-8237
2193-651X
DOI: 10.1007/s40122-022-00472-z
Popis: Abstract Purpose We compared the clinical effects of Neurotropin, limaprost alfadex, and a combination of both drugs for lumbar spinal stenosis (LSS) with low back pain (LBP). Methods We conducted a multicenter, randomized, active-controlled, open-label trial from March 2021 to May 2022. Participants were patients diagnosed with LSS by MRI and were randomly assigned to three groups: Neurotropin/limaprost combination (NL group), Neurotropin (N group), and limaprost group (L group). Participants received the drugs administered orally for 12 weeks, and each examination and observation was performed before any drug administration and every 2 weeks thereafter. We recorded age, sex, height, weight, duration of symptoms, intermittent claudication distance, level of stenosis in MRI, and concomitant analgesics as examination items in the trial period. Items measured during the trial were visual analog scale (VAS) score (mm) for LBP, leg pain and numbness, walking activity (walking speed, stride length), standing balance (3 m Timed Up-and-Go (TUG) Test results, Five Times Sit-to-Stand Test (FTSST) results), LBP/Quality of Life (QOL)-related scores (Oswestry Disability Index (ODI), Euro QOL 5-Dimensions 5-Level (EQ-5D-5L), Roland–Morris Disability Questionnaire (RDQ)), psychological factors (Pain catastrophizing scale (PCS) and Pain Self-Efficacy Questionnaire (PSEQ) scores), and adverse events. Each item was evaluated using changes at each visit (weeks 2–12) from baseline value before drug administration (week 0), and changes were considered significant when p
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