Chronic low back pain
Conditions
Interventions
Open label placebo capsule with sufficient information Taking 2 capsules/time, morning &
evening /day with confirming the effect of placebo Outcomes are assessed at baseline, 3 week and 3 months
Usual treatment Outcomes are assessed at baseline, 3 week and 3 months
Sponsors
Department of Orthopedic Surgery, Aichi Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Chronic low back pain 1)Pain is lasting for more than 6 months 2)Subjective pain magnitude is at least 3 out of 0-10 numerical rating scale
Exclusion criteria
Exclusion criteria: 1)No wish toparticipation 2)Pain radiating into lower leg 3)On going treatment of malignant tumor, spinal fractures and spinal infections 4)Autoimmune diseases 5)Spondyloarthropathy 6)Elderly aged 75 years and older whose Tscore of DXA is lower than 2.5 7)Histories of fragile spinal fractures 8)Histories or use of steroids for more than 3 months. 9)Spinal kyphosis or spinal scoliosis whose cobb angle is over 30 degree 10)Within 3 months after thoracic or lumbar surgeries 11)Taking medicaion associated with dementia 12)Suspicious cognitive disorder 13)Judged ineligible by the researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity:Numerical rating scale. Pain disability:Roland-Morris Disability Questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timed up and go test Subjective satisfaction scale | — |
Countries
Japan
Contacts
Public ContactTatsunori Ikemoto
Aichi medical university Department of Orthopedic Surgery
Outcome results
None listed