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Autologous Platelet Rich Plasma on Low Back Pain

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PRP Treatment(P)
Medication Treatment(Loxoprofen Sodium tablets,M)
Sponsored by
Shanghai Changzheng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Platelet Rich Plasma, Intervertebral Disk Injection Therapy, Low Back Pain, Ultrasound Guided, Degenerative Spinal Disease

Eligibility Criteria

18 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Changzheng HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRP Treatment(P)

Medication Treatment(M)

Arm Description

PRP intra-disk injection therapy combined with NSAIDs medication (Loxoprofen Sodium tablets).

NSAIDs medication(Loxoprofen Sodium tablets) therapy only.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Imaging change
Imaging change by MRI scan: : baseline, 1 month, 6 months, 12 months after intervention.
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).

Full Information

First Posted
November 21, 2016
Last Updated
May 4, 2022
Sponsor
Shanghai Changzheng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02983747
Brief Title
Autologous Platelet Rich Plasma on Low Back Pain
Official Title
Autologous Platelet Rich Plasma in Ultrasound Guided Intervertebral Disk Injection Therapy for Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Changzheng Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Platelet Rich Plasma, Intervertebral Disk Injection Therapy, Low Back Pain, Ultrasound Guided, Degenerative Spinal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRP Treatment(P)
Arm Type
Experimental
Arm Description
PRP intra-disk injection therapy combined with NSAIDs medication (Loxoprofen Sodium tablets).
Arm Title
Medication Treatment(M)
Arm Type
Active Comparator
Arm Description
NSAIDs medication(Loxoprofen Sodium tablets) therapy only.
Intervention Type
Other
Intervention Name(s)
PRP Treatment(P)
Other Intervention Name(s)
Platelet Rich Plasma
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Medication Treatment(Loxoprofen Sodium tablets,M)
Other Intervention Name(s)
LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .
Intervention Description
Loxoprofen Sodium tablets(LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .)，P.O., 60mg, three times a day
Primary Outcome Measure Information:
Title
Visual Analog Scale(VAS)
Description
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 Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
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
Title
Functional Rating Index
Description
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
Title
Measuring the Quality of life using SF-36 questionnaire
Description
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
Title
Imaging change
Description
Imaging change by MRI scan: : baseline, 1 month, 6 months, 12 months after intervention.
Time Frame
1 year
Title
Number of patients with side effect
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuhua Lu, M.D.
Phone
86-21-81885793
Email
xuhualu@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hai-bin Wang, M.D.
Phone
86-21-81885793
Email
wanghb0222@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuhua Lu, M.D.
Organizational Affiliation
Shanghai Changzheng Hospotal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
ZIP/Postal Code
200003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoguang Li, M.D.
Phone
86-21-81885045
Email
Chzhhospital@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Autologous Platelet Rich Plasma on Low Back Pain

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