Platelet-rich Plasma for Low Back Pain

Intradiscal Injection of Platelet-rich Plasma for Discogenic Pain in L-spine

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.

Study Overview

• Status: Completed
• Conditions: Discogenic Pain; Platelet-rich Plasma
• Intervention / Treatment: Other: Platelet-rich plasma

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Changhua
    • Changhua City, Changhua, Taiwan, 500
      • Show Chwan Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PRP group; Intradisc injection of autologous platelet-rich plasma gel	Other: Platelet-rich plasma; intradiscal injection of plasma-rich platelet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-month postoperative function evaluated by Oswestry Disability Index	Function is evaluated using Oswestry Disability Index.	1-month postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
4-month postoperative function evaluated by Oswestry Disability Index	Function is evaluated using Oswestry Disability Index	4-month postoperative
1-month postoperative pain evaluated by visual analogue scale	Pain is evaluated using visual analogue scale	1-month postoperative
4-month postoperative pain evaluated by visual analogue scale	Pain is evaluated using visual analogue scale	4-month postoperative

Collaborators and Investigators

• Sponsor: Pei-Yuan Lee, MD
• Collaborators: Aeon Biotechnology Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 22, 2016
• Primary Completion (ACTUAL): March 25, 2019
• Study Completion (ACTUAL): March 25, 2019

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (ACTUAL): June 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 5, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Low Back Pain; Platelet-rich plasma; Intervertebral Disc Degeneration
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: RA-16025-RD-105064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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