Autologous Platelet Rich Plasma on Low Back Pain

Not Applicable

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

• Registration Number: NCT02983747
• Lead Sponsor: Shanghai Changzheng Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-21
• Study First Submitted QC: 2016-12-02
• Study First Posted: 2016-12-06
• Study Start: 2019-11-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-09
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRP Treatment(P)	PRP Treatment(P)	PRP intra-disk injection therapy combined with NSAIDs medication (Loxoprofen Sodium tablets).
PRP Treatment(P)	Medication Treatment(Loxoprofen Sodium tablets,M)	PRP intra-disk injection therapy combined with NSAIDs medication (Loxoprofen Sodium tablets).
Medication Treatment(M)	Medication Treatment(Loxoprofen Sodium tablets,M)	NSAIDs medication(Loxoprofen Sodium tablets) therapy only.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale(VAS)	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Functional Rating Index	1 year	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.
Oswestry Disability Index (ODI)	1 year	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.
Measuring the Quality of life using SF-36 questionnaire	1 year	Functions evaluated using change from baseline in SF-36:baseline, 1 week ,and 1 month, 2 months, 6 months, 12 months after intervention.
Imaging change	1 year	Imaging change by MRI scan: : baseline, 1 month, 6 months, 12 months after intervention.
Number of patients with side effect	Within 1 year after injection therapy	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).

Trial Locations

Locations (1)

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, China