low back pain
Conditions
Interventions
Group A: PRP releasate, 2 mL, was injected through a syringe filer (Millex GV Filter unit, Cat. #SLGV M33 RS, Millipore, Billerica, MA, USA).
Group B: Betamethasone sodium phosphate (Rinderon, Sionogi
Co., LTD) (2 mg, 0.5 ml) + saline (1.5 ml)
Sponsors
Mie University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Having low back pain more than three month Visual analogue scare (VAS): more than 40% at baseline ODI: more than 40% at bassline Disc degeneration evaluated by MRI (more than grade II by Pfirrmann grading) from L3/4 to L4/5 lumbar disc Less than 50% decrease of disc height measurement by lumbar radiograph Discogenic pain evaluated by provocative discography Written informed consent is obtained from the participant of this study
Exclusion criteria
Exclusion criteria: Having remarkable cauda equine and neuropathy symptom Having systematic or spinal infection Past-history of lumbar surgeries Past-history of interventional intervertebral disc therapy Having intervertebral instability evaluated by lumbar radiograph Patients having spondylolisthesis (more than grade I by Meyerding classification) Having neuro-muscular diseases, cerebral diseases, malignant tumor and blood coagulation disorders High risk for infectious diseases after the treatment Having anti-coagulant drugs at the time of treatment Pregnant patient Difficulty in participating throughout the evaluation period More than 10-points of BS-POS questionnaire test Contraindication for MRI Inappropriate patient for clinical study evaluate by doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in VAS (Visual Analogue Scale) at 8 weeks after the injection from VAS at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in VAS (Visual Analogue Scale) at 4, 12, 26, 52 weeks after the injection from VAS at baseline. Percent change in VAS at 4, 8, 12, 26, 52 weeks after the injection from VAS at baseline. Change and % change in ODI (Oswestry Disability Index) at 4, 8, 12, 26, 52 weeks after the injection from VAS at baseline. Change in VAS (Visual Analogue Scale) at 4, 12, 26, 52 weeks after the injection from VAS at baseline. Percent (%) change in VAS at 4, 8, 12, 26, 52 weeks after the injection from VAS at baseline. Change and % change in ODI (Oswestry Disability Index) at 4, 8, 12, 26, 52 weeks after the injection from VAS at baseline. Change and % change in the Roland-Morris Disability Questionnaire (RDQ) at 4, 8, 12, 26, 52 weeks after the injection from VAS at baseline. Change and % change in JOA Back Pain Evaluation Questionnaire (JOABPEQ) at 4, 8, 12, 26, 52 weeks after the injection from VAS at baseline. Change in MRI grading at 26 and 52 weeks after the injection from bassline. Change in radiographic disc height at 4, 8, 12, 26, 52 weeks after the injection from that at baseline. Frequency and amount in use of short-term NSAIDs until 4, 8, 12, 26, 52 weeks after the injection A successful ratio of the treatment at 8, 12, 26, 52 weeks after the treatment. *When the subjects receive the optional treatment, the secondary outcomes are evaluated at 4, 8, 12, 26, 52 weeks after the optional treatment. | — |
Countries
Japan
Contacts
Public ContactKoji Akeda
Mie University Hospital Orthopaedic Surgery
Outcome results
None listed