Autologous Platelet Rich Plasma on Low Back Pain

Shanghai Changzheng Hospital112 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

112

Conditions

Low Back Pain

Interventions

PRP Treatment(P)OTHER

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

Medication Treatment(Loxoprofen Sodium tablets,M)DRUG

Loxoprofen Sodium tablets(LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .)，P.O., 60mg, three times a day

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Shanghai Changzheng Hospital

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Xuhua Lu, M.D.

CONTACT

86-21-81885793 xuhualu@hotmail.com

Hai-bin Wang, M.D.

CONTACT

86-21-81885793 wanghb0222@hotmail.com

Data from ClinicalTrials.gov

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