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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP Treatment(P) | Experimental | PRP intra-disk injection therapy combined with NSAIDs medication (Loxoprofen Sodium tablets). |
|
| Medication Treatment(M) | Active Comparator | NSAIDs medication(Loxoprofen Sodium tablets) therapy only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP Treatment(P) | Other | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuhua Lu, M.D. | Contact | 86-21-81885793 | xuhualu@hotmail.com | |
| Hai-bin Wang, M.D. | Contact | 86-21-81885793 | wanghb0222@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xuhua Lu, M.D. | Shanghai Changzheng Hospotal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changzheng Hospital | Recruiting | Shanghai | 200003 | China |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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|
| Medication Treatment(Loxoprofen Sodium tablets,M) | Drug | Loxoprofen Sodium tablets(LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .)，P.O., 60mg, three times a day |
|
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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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |