Low Back Pain
Conditions
Keywords
Platelet Rich Plasma, Intervertebral Disk Injection Therapy, Low Back Pain, Ultrasound Guided, Degenerative Spinal Disease
Brief summary
The purpose of this study is to evaluate the effectiveness of autologous platelet-rich plasma (PRP) injection therapy for low back pain patients. Our hypothesis is that PRP will reduce the pain feeling and benefit for restore of the intervertebral disk.
Interventions
OTHERPRP Treatment(P)
Ultrasound(Philips® iU22 ultrasound system) guided intra-disk injection using 2 ml of platelet rich plasma, containing 0.2 ml of calcium chloride(SINE®, SHANGHAI XINYI PHARMACEUTIAL Co . Ltd .) per treatment
DRUGMedication Treatment(Loxoprofen Sodium tablets,M)
Loxoprofen Sodium tablets(LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .)，P.O., 60mg, three times a day
Sponsors
Shanghai Changzheng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Chronic low back pain more than 2months * Visual analog scale score more than 4 * Positive X-ray, MRI or CT scan findings * Pfirrmann grading I-III * Well understanding and communication ability
Exclusion criteria
* History of allergy * Hemorrhagic trend or use of anticoagulant therapy * Mental diseases * Active infection or recent infectious diseases within 3 months * Local skin infection near the puncture location * Severe lumbar spinal stenosis, lumbar spondylolisthesis, ossification of posterior longitudinal * Ligament and lumbar disc herniation（more than 5mm） * Immunologic diseases * Tumors * Metastatic disease * Recent surgery less than 3 months) * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale(VAS) | 1 year | Pain relief evaluated using change from baseline in Visual Analog Scale (VAS):baseline, 1 week ,and 1 month, 2 months, 6 months, 12 months after intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) | 1 year | Pain relief and functions evaluated using change from baseline in Oswestry Disability Index (ODI): baseline, 1 week ,and 1 month, 2 months, 6 months, 12 months after intervention. |
| Functional Rating Index | 1 year | Spinal functions evaluated using change from baseline by Functional Rating Index: baseline, 1 week ,and 1 month, 2 months, 6 months, 12 months after intervention. |
| Measuring the Quality of life using SF-36 questionnaire | 1 year | Functions evaluated using change from baseline in SF-36:baseline, 1 week ,and 1 month, 2 months, 6 months, 12 months after intervention. |
| Imaging change | 1 year | Imaging change by MRI scan: : baseline, 1 month, 6 months, 12 months after intervention. |
| Number of patients with side effect | Within 1 year after injection therapy | Record how many patients had side effects after intervention (eg.aggravation of pain\*(VAS change increased more than 3 from baseline),anaphylaxis,sensory/motion disturbances). |
Countries
China
Contacts
Primary ContactXuhua Lu, M.D.
Backup ContactHai-bin Wang, M.D.
Outcome results
None listed