Clinical research on neurotropin tablets in low back pain patients with sarcopenia

INTERVENTION: Study drug: Oral administration of 2 Neurotropin tablets twice a day (morning and evening) for 12 weeks Control drug: Oral administration of two placebo tablets twice a day (morning and evening) for 12 weeks CONDITION: Low back pain with sarcopenia PRIMARY OUTCOME: Change in 4‐meters walking speed after 12 weeks of administration from before administration SECONDARY OUTCOME: (1) Changes from before the start of administration in 4‐meters walking speed at 4 weeks and 8 weeks after administration; (2) Changes from before the start of administration in the following indicators at 4 weeks, 8 weeks, and 12 weeks after administration; Skeletal muscle mass by BIA method, grip strength, BMI, five‐time chair rise time, balance test, lower leg circumference, SPPB (comprehensive score calculated from three tests: walking speed, time to rise from chair, balance test), QOL questionnaire EQ‐5D‐5L score; (3) Changes from before the start of administration in lumbago VAS values at 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, and 12 weeks after administration INCLUSION CRITERIA: (1) Patients diagnosed with low back pain by the investigator (2) Patients aged 65 or older at the time of obtaining consent (3) Regardless of gender (4) Patients who meet all of the following criteria 1. Grip strength Less than 28 kg for male, less than 18 kg for female. 2. 4m walking speed Walking speed <1.0m/s 3. Skeletal muscle mass Less than 7.0 kg/m2 for male (BIA method) Less than 5.4 kg/m2 for female (BIA method) (5) Patients who have given written informed consent of their own free will after receiving a sufficient explanation for participating in this research (6) Patients who are able to go to the outpatient clinic according to the study schedule (7) Patients who can comply with the regulations for prohibited concomitant drugs and prohibited concomitant therapies (see ''7.4.1 Prohibited concomitant drugs and prohibited concomitant therapies'')