Platelet-rich Plasma for Low Back Pain

Platelet-rich Plasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197415
• Other study ID #: RA-16025-RD-105064
• Status: Completed
• Phase: N/A
• Start date: April 22, 2016
• Est. completion date: March 25, 2019

Study information

• Verified date: September 2019
• Source: Show Chwan Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 25, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Discogenic Pain
• Low Back Pain
• Platelet-rich Plasma

Intervention

Other:
• Platelet-rich plasma
intradiscal injection of plasma-rich platelet

Locations

Country	Name	City	State
Taiwan	Show Chwan Memorial Hospital	Changhua City	Changhua

Sponsors (2)

Lead Sponsor	Collaborator
Pei-Yuan Lee, MD	Aeon Biotechnology Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-month postoperative function evaluated by Oswestry Disability Index	Function is evaluated using Oswestry Disability Index.	1-month postoperative
Secondary	4-month postoperative function evaluated by Oswestry Disability Index	Function is evaluated using Oswestry Disability Index	4-month postoperative
Secondary	1-month postoperative pain evaluated by visual analogue scale	Pain is evaluated using visual analogue scale	1-month postoperative
Secondary	4-month postoperative pain evaluated by visual analogue scale	Pain is evaluated using visual analogue scale	4-month postoperative