Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
112 participants
INTERVENTIONAL
2019-11-01
2022-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PRP Treatment(P)
PRP intra-disk injection therapy combined with NSAIDs medication (Loxoprofen Sodium tablets).
PRP 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
Medication Treatment(Loxoprofen Sodium tablets,M)
Loxoprofen Sodium tablets(LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .)，P.O., 60mg, three times a day
Medication Treatment(M)
NSAIDs medication(Loxoprofen Sodium tablets) therapy only.
Medication Treatment(Loxoprofen Sodium tablets,M)
Loxoprofen Sodium tablets(LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .)，P.O., 60mg, three times a day
Interventions
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PRP 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
Medication Treatment(Loxoprofen Sodium tablets,M)
Loxoprofen Sodium tablets(LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .)，P.O., 60mg, three times a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
MALE
No
Sponsors
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Shanghai Changzheng Hospital
OTHER
Responsible Party
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Xuhua Lu
Vice Director of Spine Surgery
Principal Investigators
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Xuhua Lu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shanghai Changzheng Hospotal
Locations
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Shanghai Changzheng Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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201540379
Identifier Type: -
Identifier Source: org_study_id
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