Autologous Platelet Rich Plasma on Low Back Pain

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

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: PRP Treatment(P); Drug: Medication Treatment(Loxoprofen Sodium tablets,M)

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xuhua Lu, M.D.; Phone Number: 86-21-81885793; Email: xuhualu@hotmail.com
• Study Contact Backup: Name: Hai-bin Wang, M.D.; Phone Number: 86-21-81885793; Email: wanghb0222@hotmail.com

Study Locations

• China
  • Shanghai, China, 200003
    • Recruiting
    • Shanghai Changzheng Hospital
    • Contact: Xiaoguang Li, M.D.; Phone Number: 86-21-81885045; Email: Chzhhospital@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRP Treatment(P); PRP intra-disk injection therapy combined with NSAIDs medication (Loxoprofen Sodium tablets).	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; Other Names: Platelet Rich Plasma; Drug: Medication Treatment(Loxoprofen Sodium tablets,M); Loxoprofen Sodium tablets(LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .)，P.O., 60mg, three times a day; Other Names: LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .
Active Comparator: Medication Treatment(M); NSAIDs medication(Loxoprofen Sodium tablets) therapy only.	Drug: Medication Treatment(Loxoprofen Sodium tablets,M); Loxoprofen Sodium tablets(LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .)，P.O., 60mg, three times a day; Other Names: LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Shanghai Changzheng Hospital
• Investigators: Principal Investigator: Xuhua Lu, M.D., Shanghai Changzheng Hospotal

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: November 21, 2016
• First Submitted That Met QC Criteria: December 2, 2016
• First Posted (Estimate): December 6, 2016

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Low Back Pain; Platelet Rich Plasma; Ultrasound Guided; Intervertebral Disk Injection Therapy; Degenerative Spinal Disease
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Loxoprofen
• Other Study ID Numbers: 201540379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No