Autologous Platelet Rich Plasma on Low Back Pain

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02983747
• Other study ID #: 201540379
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2022
• Source: Shanghai Changzheng Hospital
• Contact: Xuhua Lu, M.D.
• Phone: 86-21-81885793
• Email: xuhualu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• 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

Drug:
• Medication Treatment(Loxoprofen Sodium tablets,M)
Loxoprofen Sodium tablets(LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .),P.O., 60mg, three times a day

Locations

Country	Name	City	State
China	Shanghai Changzheng Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Imaging change	Imaging change by MRI scan: : baseline, 1 month, 6 months, 12 months after intervention.	1 year
Secondary	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