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OpenTrials
Completed

NCT Number: NCT03197415

Platelet-rich Plasma for Low Back Pain

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Show Chwan Memorial Hospital

Changhua, 500, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet-rich plasma

Other

intradiscal injection of plasma-rich platelet

Primary outcomes

  1. 1-month postoperative function evaluated by Oswestry Disability Index

    Time frame: 1-month postoperative

    Function is evaluated using Oswestry Disability Index.

Secondary outcomes

  1. 4-month postoperative function evaluated by Oswestry Disability Index

    Time frame: 4-month postoperative

    Function is evaluated using Oswestry Disability Index

  2. 1-month postoperative pain evaluated by visual analogue scale

    Time frame: 1-month postoperative

    Pain is evaluated using visual analogue scale

  3. 4-month postoperative pain evaluated by visual analogue scale

    Time frame: 4-month postoperative

    Pain is evaluated using visual analogue scale

Sponsors and collaborators

Lead sponsor

Pei-Yuan Lee, MD

Other

Collaborators

  • Aeon Biotechnology Corporation

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 23, 2017
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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