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| Name | Class |
|---|---|
| Aeon Biotechnology Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP group | Experimental | Intradisc injection of autologous platelet-rich plasma gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet-rich plasma | Other | intradiscal injection of plasma-rich platelet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1-month postoperative function evaluated by Oswestry Disability Index | Function is evaluated using Oswestry Disability Index. | 1-month postoperative |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pei-Yuan Lee, MD | Show Chwan Memorial Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Show Chwan Memorial Hospital | Changhua | Changhua | 500 | Taiwan |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001416 | Back Pain |
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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 |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |