An interventional study of PRP Treatment(P) and Medication Treatment(Loxoprofen Sodium tablets,M) in Low Back Pain, sponsored by Shanghai Changzheng Hospital. Status unknown at 1 site in China. Open to male participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-05-09.
Sponsored by Shanghai Changzheng Hospital · Not applicable, Interventional, and Treatment
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.
2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.
This study's planned enrollment of 112 is above the median of 60 across 2,315 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Shanghai Changzheng Hospital is the lead sponsor of 128 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
PRP intra-disk injection therapy combined with NSAIDs medication (Loxoprofen Sodium tablets).
Other: PRP Treatment(P) · Drug: Medication Treatment(Loxoprofen Sodium tablets,M)
NSAIDs medication(Loxoprofen Sodium tablets) therapy only.
Drug: Medication Treatment(Loxoprofen Sodium tablets,M)
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
Also known as: Platelet Rich Plasma
Loxoprofen Sodium tablets(LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .)，P.O., 60mg, three times a day
Also known as: LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .
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.
Time frame: 1 year
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Imaging change
Imaging change by MRI scan: : baseline, 1 month, 6 months, 12 months after intervention.
Time frame: 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).
Time frame: Within 1 year after injection therapy
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2019 (actual). Primary completion is estimated for Dec 2022, 37 months after the start.
Of 1,187 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 37 months is above that.
Counting every sponsor, half of 1,246 studies reached it within 11 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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