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Platelet-rich Plasma for Low Back Pain

Primary Purpose

Discogenic Pain, Platelet-rich Plasma

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Platelet-rich plasma
Sponsored by
Pei-Yuan Lee, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Discogenic Pain focused on measuring Platelet-rich plasma, Intervertebral Disc Degeneration, Low Back Pain

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 20 and 60 years
  • L-spine disc degeneration diagnosed by MRI
  • Low back pain

Exclusion Criteria:

  • Herniated disc
  • With prior history of spine surgery
  • With current or prior history of cancer
  • With current or prior history of hematological disease
  • Pregnancy
  • Patients who will not cooperate with one-year followup

Sites / Locations

  • Show Chwan Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRP group

Arm Description

Intradisc injection of autologous platelet-rich plasma gel

Outcomes

Primary Outcome Measures

1-month postoperative function evaluated by Oswestry Disability Index
Function is evaluated using Oswestry Disability Index.

Secondary Outcome Measures

4-month postoperative function evaluated by Oswestry Disability Index
Function is evaluated using Oswestry Disability Index
1-month postoperative pain evaluated by visual analogue scale
Pain is evaluated using visual analogue scale
4-month postoperative pain evaluated by visual analogue scale
Pain is evaluated using visual analogue scale

Full Information

First Posted
April 13, 2017
Last Updated
September 5, 2019
Sponsor
Pei-Yuan Lee, MD
Collaborators
Aeon Biotechnology Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03197415
Brief Title
Platelet-rich Plasma for Low Back Pain
Official Title
Intradiscal Injection of Platelet-rich Plasma for Discogenic Pain in L-spine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 22, 2016 (Actual)
Primary Completion Date
March 25, 2019 (Actual)
Study Completion Date
March 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pei-Yuan Lee, MD
Collaborators
Aeon Biotechnology Corporation

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
This study aims to evaluate the effect of platelet-rich plasma (PRP) on discogenic low back pain by comparing the pre- and post-interventional outcomes in patients receiving intradiscal injection of autologous PRP.
Detailed Description
Intervertebral disc (IVD) degeneration is an important clinical problem that often contributes to low back pain and degenerative disc diseases. Degeneration of the IVD induces anulus tears and fissures, which can cause severe discogenic low back pain. Because the IVD has little potential to self-regenerate, treatment of degenerative disc disease is one of the most challenging clinical problems facing the spine surgeon. Platelet-rich plasma (PRP) is a fraction of plasma that contains platelets and multiple growth factors concentrated at high level. Because activated platelets have the potential to release growth factors, PRP has been clinically used to accelerate wound healing and tissue regeneration in orthopedic and oral surgery. The soluble releasate isolated from PRP has recently been demonstrated to influence the metabolism of intervertebral discs in vitro. Furthermore, an intradiscal injection of autologous PRP has been shown to induce restoration of structural changes in the rabbit annular injection model in vivo. This clinical trial aims to investigate the safety and efficacy of intradiscal PRP injection in patients with discogenic low back pain. The pre- and post-interventional imaging and clinical outcomes will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discogenic Pain, Platelet-rich Plasma
Keywords
Platelet-rich plasma, Intervertebral Disc Degeneration, Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP group
Arm Type
Experimental
Arm Description
Intradisc injection of autologous platelet-rich plasma gel
Intervention Type
Other
Intervention Name(s)
Platelet-rich plasma
Intervention Description
intradiscal injection of plasma-rich platelet
Primary Outcome Measure Information:
Title
1-month postoperative function evaluated by Oswestry Disability Index
Description
Function is evaluated using Oswestry Disability Index.
Time Frame
1-month postoperative
Secondary Outcome Measure Information:
Title
4-month postoperative function evaluated by Oswestry Disability Index
Description
Function is evaluated using Oswestry Disability Index
Time Frame
4-month postoperative
Title
1-month postoperative pain evaluated by visual analogue scale
Description
Pain is evaluated using visual analogue scale
Time Frame
1-month postoperative
Title
4-month postoperative pain evaluated by visual analogue scale
Description
Pain is evaluated using visual analogue scale
Time Frame
4-month postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 20 and 60 years L-spine disc degeneration diagnosed by MRI Low back pain Exclusion Criteria: Herniated disc With prior history of spine surgery With current or prior history of cancer With current or prior history of hematological disease Pregnancy Patients who will not cooperate with one-year followup
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Yuan Lee, MD
Organizational Affiliation
Show Chwan Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Show Chwan Memorial Hospital
City
Changhua City
State/Province
Changhua
ZIP/Postal Code
500
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Platelet-rich Plasma for Low Back Pain

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