Clinical trial NCT03197415: Platelet-rich Plasma for Low Back Pain
Official title: Intradiscal Injection of Platelet-rich Plasma for Discogenic Pain in L-spine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Discogenic Pain
Platelet-rich Plasma
Keywords: Platelet-rich plasma
Intervertebral Disc Degeneration
Low Back Pain
Lead sponsor: Show Chwan Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Aeon Biotechnology Corporation
First posted: 2017-06-23
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 1-month postoperative function evaluated by Oswestry Disability Index
timeFrame: 1-month postoperative
Secondary outcomes:
measure: 4-month postoperative function evaluated by Oswestry Disability Index
timeFrame: 4-month postoperative
measure: 1-month postoperative pain evaluated by visual analogue scale
timeFrame: 1-month postoperative
measure: 4-month postoperative pain evaluated by visual analogue scale
timeFrame: 4-month postoperative
Other outcomes:
Locations:
city: Changhua City
country: Taiwan
facility: Show Chwan Memorial Hospital
state: Changhua
Study officials:
affiliation: Show Chwan Memorial Hospital
name: Pei-Yuan Lee, MD
role: STUDY_CHAIR
References: