Platelet-rich Plasma for Low Back Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Platelet-rich Plasma, Discogenic Pain

Intervention / Treatment
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* Other: Platelet-rich plasma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP group<br>Intradisc injection of autologous platelet-rich plasma gel | Other: Platelet-rich plasma<br>* intradiscal injection of plasma-rich platelet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-month postoperative function evaluated by Oswestry Disability Index | Function is evaluated using Oswestry Disability Index. | 1-month postoperative | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet-rich plasma, Intervertebral Disc Degeneration, Low Back Pain