Discogenic Pain, Platelet-rich Plasma
Conditions
Keywords
Platelet-rich plasma, Intervertebral Disc Degeneration, Low Back Pain
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.
Interventions
OTHERPlatelet-rich plasma
intradiscal injection of plasma-rich platelet
Sponsors
Aeon Biotechnology Corporation
Pei-Yuan Lee, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-month postoperative function evaluated by Oswestry Disability Index | 1-month postoperative | Function is evaluated using Oswestry Disability Index. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 4-month postoperative function evaluated by Oswestry Disability Index | 4-month postoperative | Function is evaluated using Oswestry Disability Index |
| 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 |
Countries
Taiwan
Outcome results
None listed