Platelet-rich Plasma for Low Back Pain

Not Applicable

Completed

• Conditions: Platelet-rich Plasma; Discogenic Pain

• Registration Number: NCT03197415
• Lead Sponsor: Pei-Yuan Lee, MD

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.

Study Timeline

• Study Start: 2016-04-22
• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-06-21
• Study First Posted: 2017-06-23
• Primary Completion: 2019-03-25
• Study Completion: 2019-03-25
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-05
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Show Chwan Memorial Hospital; 🇨🇳 Changhua City, Changhua, Taiwan