Low back pain with sarcopenia
Conditions
Interventions
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 1
Sponsors
Sumitani Masahiko
Eligibility
Sex/Gender
All
Inclusion criteria
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. 4m walking speed Walking speed <1.0m/s 2. Skeletal muscle mass 7.9 kg/m2 or less for male (BIA method) 6.3 kg/m2 or less 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'')
Exclusion criteria
Exclusion criteria: Those who meet even one of the following exclusion criteria will be excluded from subjects to be registered. (1) Patients with a history of hypersensitivity to the study drug (2) Patients with significant cognitive decline or mental illness (3) Patients who have difficulty using devices used for efficacy evaluation due to their physique, etc. (4) Patients who continue to administer preparations containing vaccinia virus-inoculated rabbit skin extract (5) Patients whose results of laboratory tests meet the following conditions 1. ALT is 2.5 times or more of the upper limit of the reference value 2. AST is 2.5 times or more of the upper limit of the reference value (6) Those who have participated in other clinical trials or clinical research (excluding observational studies) within 6 months prior to written consent (7) Patients with diseases that should be prioritized for treatment other than frailty or sarcopenia due to low back pain (8) In addition, those who are judged inappropriate to participate in this study by the principal investigator or co-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 4-meters walking speed after 12 weeks of administration from before administration | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 | — |
Contacts
Public ContactMasahiko Sumitani
The University of Tokyo Hospital
Outcome results
None listed