None listed
Conditions
Interventions
Medical Device : Apply 10 times for 3 Weeks to CGM MB-1901 or CGM MB-1901C.
Sponsors
Ceragem
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who voluntarily consented, after listing enough explanation for this study and investigational device. 2) The following low back pain patients. (1) Over 40mm of VAS(Visual Analog Scale) (2) Chronic(last over 12 weeks) non-specific low back pain 3) Body mass index(BMI) over 18.5 and under 30
Exclusion criteria
Exclusion criteria: 1) inflammatory spondylitis(spondylitis ankylopoietica, Other auto-disease spondylitis, infections etc.) 2) Scoliosis with Cobb angle> 30° 3) Under -2.5 SD of Osteoporosis 4) Spine fracture, serious trauma, operation in 6 months from Screening Visit 5) A systemic pain disorder : Fibromyalgia, depression etc. 6) Over 20 Score at Beck Depression Inventory II 7) Spondylosyndesis, artificial disc replacement or metallic implant patient at apply part of investigational device 8) Local aneurysm of plan for apply part of investigational device 9) skin excoriation, open wound, wound, scar of plan for apply part of investigational device 10) Subject who has plan to major surgery or surgery which barrier to judge for evaluate low back pain and apply investigational device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The value change of 100mm Visual Analog Scale(VAS) in EOT(End of Treatment) relative to the baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| The value change of 100mm Visual Analog Scale(VAS) in each evaluation time(1st evaluate visit and 2nd evaluate visit) relative to the baseline;The fraction of improved subjects over 20% in each evaluation time(1st evaluate visit and 2nd evaluate visit, End of Treatment) relative to the baseline | — |
Countries
Korea, Republic of
Contacts
Public ContactWhan-Seok Choi
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed