Autologous Platelet Rich Plasma on Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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Autologous Platelet Rich Plasma in Ultrasound Guided Intervertebral Disk Injection Therapy for Chronic Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: PRP Treatment(P)
* Drug: Medication Treatment(Loxoprofen Sodium tablets,M)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP Treatment(P)<br>PRP intra-disk injection therapy combined with NSAIDs medication (Loxoprofen Sodium tablets). | Other: PRP Treatment(P)<br>* 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<br>* Other names: Platelet Rich Plasma;Drug: Medication Treatment(Loxoprofen Sodium tablets,M)<br>* Loxoprofen Sodium tablets(LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .)，P.O., 60mg, three times a day<br>* Other names: LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .;|
| Active Comparator: Medication Treatment(M)<br>NSAIDs medication(Loxoprofen Sodium tablets) therapy only. | Drug: Medication Treatment(Loxoprofen Sodium tablets,M)<br>* Loxoprofen Sodium tablets(LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .)，P.O., 60mg, three times a day<br>* Other names: LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale(VAS) | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) | 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. | 1 year | 
| Functional Rating Index | 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. | 1 year | 
| Measuring the Quality of life using SF-36 questionnaire | Functions evaluated using change from baseline in SF-36:baseline, 1 week ,and 1 month, 2 months, 6 months, 12 months after intervention. | 1 year | 
| Imaging change | Imaging change by MRI scan: : baseline, 1 month, 6 months, 12 months after intervention. | 1 year | 
| Number of patients with side effect | 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). | Within 1 year after injection therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Back Pain, Platelet Rich Plasma, Intervertebral Disk Injection Therapy, Ultrasound Guided, Degenerative Spinal Disease