Autologous Platelet Rich Plasma on Low Back Pain
1 other identifier
interventional
112
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable low-back-pain
Started Nov 2019
Longer than P75 for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2016
CompletedFirst Posted
Study publicly available on registry
December 6, 2016
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedMay 9, 2022
May 1, 2022
3.2 years
November 21, 2016
May 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Oswestry Disability Index (ODI)
1 year
Functional Rating Index
1 year
Measuring the Quality of life using SF-36 questionnaire
1 year
Imaging change
1 year
Number of patients with side effect
Within 1 year after injection therapy
Study Arms (2)
PRP Treatment(P)
EXPERIMENTALPRP intra-disk injection therapy combined with NSAIDs medication (Loxoprofen Sodium tablets).
Medication Treatment(M)
ACTIVE COMPARATORNSAIDs medication(Loxoprofen Sodium tablets) therapy only.
Interventions
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
Loxoprofen Sodium tablets(LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .)，P.O., 60mg, three times a day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Changzheng Hospital
Shanghai, 200003, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xuhua Lu, M.D.
Shanghai Changzheng Hospotal
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Director of Spine Surgery
Study Record Dates
First Submitted
November 21, 2016
First Posted
December 6, 2016
Study Start
November 1, 2019
Primary Completion
December 30, 2022
Study Completion
December 30, 2022
Last Updated
May 9, 2022
Record last verified: 2022-05