Intradiscal and Intra-articular Injection of Autologous Platelet-Rich-Plasma (PRP) in Patients With Lumbar Degenerative Disc Disease and Facet Joint Syndrome

NCT ID: NCT04816747

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2024-10-31

Brief Summary

Autologous Platelet-Rich-Plasma (PRP) represents a regenerative therapy that has gained remarkable ground in the field of orthopaedics in recent years. PRP has been implemented for a plethora of musculoskeletal ailments, being associated with minor complications and noteworthy efficacy (Akeda et al., 2019). PRP has been depicted to contain a variety of growth factors crucial for regulation of cell proliferation and migration as well as extracellular matrix synthesis (Cheng et al., 2019). Furthermore, therapeutic effect of PRP administration is considered to be additionally exerted via its anti-inflammatory and immunoregulative properties, as it has been delineated to induce regional decrease of pro-inflammatory mediators at the injection site (Hirase et al., 2020).

Lumbar Degenerative Disc Disease (DDD) and Facet Joint Syndrome (FJS) constitute chronic degenerative conditions of lumbar spine that have been associated with substantial morbidity and disability in recent years. Besides the noted progress in comprehension of these conditions' pathogenesis, available therapeutic modalities remain extremely limited and controversial, being not capable of altering the natural progress of underlying disease (Wu et al., 2016; Wu et al., 2017; Hirase et al., 2020).

Autologous PRR has been recommended as a beneficial alternative instead of conventional treatment strategies for interventional management of lumbar DDD and FJS (Aufiero et al., 2015; Navani and Hames, 2015; Kirchner and Anitua, 2016; Levi et al., 2016; Tuakli-Wosornu et al., 2016; Wu et al., 2016; Akeda et al., 2017; Lutz GE, 2017; Wu et al., 2017; Cheng et al., 2019). Results of these studies indicated that intra-discal and intra-articular injection of PRP for DDD and FJS respectively is characterized by safety and satisfactory efficacy in reducing intensity of clinical manifestations, exerting also potentially regenerative effects. However, quality of available evidence is remarkably low, since in the overwhelming majority of these studies was a limited number of patients evaluated. Furthermore, determined follow-up intervals were not extended and, most importantly, patients were not majorly with rigorous clinical and radiologic criteria selected.

Aim of this study is to investigate the precise effects of intradiscal and intra-articular injection of PRP in patients with early-stage lumbar DDD and FJS, as determined by particular radiologic classifications. The prospective design, the defined greater number of recruited individuals in pilot analysis as well as the comparatively greater follow-up underline the originality of our protocol.

Conditions

Degenerative Disc Disease; Facet Joint Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous PRP

Participants with diagnosed lumbar DDD are planned to be managed via intradiscal injection of 0.5-1 ml autologous PRP, whereas participants with FJS will be injected with 0.5 ml of respective solution. All procedures will be performed in surgical theatre under constant fluoroscopic guidance.

Group Type: EXPERIMENTAL

Autologous PRP

Intervention Type: BIOLOGICAL

Participants enrolled in this study will be managed with intradiscal and/or intra-articular injections of autologous PRP according to features of underlying pathology. Participants featuring FJS will be prior to PRP diagnostically and therapeutically injected with local anesthetic in order to verify FJS as the etiology of experienced pain. Injected PRP solution volume is designed to be 0.5-1 ml and 0.5 ml in cases of intradiscal and intra-articular injection, respectively. All participants are planned to receive a single dose of PRP, whilst a maximum of two compromised discs and four facet joints will be treated in each patient.

Interventions

Autologous PRP

Participants enrolled in this study will be managed with intradiscal and/or intra-articular injections of autologous PRP according to features of underlying pathology. Participants featuring FJS will be prior to PRP diagnostically and therapeutically injected with local anesthetic in order to verify FJS as the etiology of experienced pain. Injected PRP solution volume is designed to be 0.5-1 ml and 0.5 ml in cases of intradiscal and intra-articular injection, respectively. All participants are planned to receive a single dose of PRP, whilst a maximum of two compromised discs and four facet joints will be treated in each patient.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Recurring low back pain persistent for more than 6 months demonstrating discogenic origin (i.e. localized at midline, exacerbated in seated position and alleviated in bed rest)
• Failure of initially implemented conservative measures (medication regimen and/or physical therapy sessions or other injections)
• Imaginary findings of Grade I-III DDD according to radiologic MRI-based classification proposed by Pfirrmann et al. (Pfirrmann et al., 2001)

• Recurring low back pain persistent for more than 6 months with no radiation to buttock or lower limb, presence of exacerbation in lateral bending, rotation and extension and paraspinal localization featuring reproduction with pressure.
• Failure of conservative treatment measures (medication regimen and/or physical therapy sessions or other injections).
• Radiologic findings of Grade I-II FJS according to CT-based classification proposed by Suri et al. (Suri et al., 2010)

Exclusion Criteria

• Presence of local or systemic infection signs (clinical and laboratory)
• Concurrent known systemic inflammatory disease with musculoskeletal manifestations or other chronic inflammatory disease
• Concurrent known hemorrhagic disorder or antithrombotic regimen
• Presence of Grade IV-V DDD according to Pfirrmann classification (Pfirrmann et al., 2001)
• Spondylolysis/Spondylolisthesis
• Intervertebral Disc Herniation
• Previous spinal surgery
• Spinal Stenosis
• Primary or Secondary spinal tumour
• Spinal fracture in past 6 months
• Diagnosed psychiatric disorder
• Epidural steroid or other intradiscal injection or within past 30 days
• Administration of NSAIDs, steroids or dietary supplements with anti-inflammatory properties within past 30 days.

Β. Participants with lumbar FJS

• Clinical manifestations of radiculopathy
• Presence of local or systemic infection signs (clinical and laboratory)
• Concurrent known systemic inflammatory disease with musculoskeletal manifestations or other chronic inflammatory disease
• Concurrent known hemorrhagic disorder or antithrombotic regimen.
• Presence of Grade III-IV FJS according to proposed classification of Suri et al. (Suri et al., 2010)
• Spondylolysis/Spondylolisthesis
• Intervertebral Disc Herniation
• Previous spinal surgery
• Spinal Stenosis
• Primary or Secondary spinal tumour
• Spinal fracture in past 6 months
• Diagnosed psychiatric disorder
• Previous intra-articular steroid injection within past 30 days
• Administration of NSAIDs, steroids or dietary supplements with anti-inflammatory properties within past 30 days.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: collaborator

Stylianos Kapetanakis

OTHER

Sponsor Role: lead

Responsible Party

Stylianos Kapetanakis

Director of Spine Department and Deformities (Interbalkan European Medical Center, Thessaloniki, Greece) and Department of Minimally Invasive and Endoscopic Spine Surgery (Athens Medical Center, Athens, Greece)

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stylianos Kapetanakis, Assistant Professor

Role: PRINCIPAL_INVESTIGATOR

Spine Department and Deformities, Interbalkan European Medical Center, Thessaloniki, PC 55535, Greece; Department of Minimally Invasive and Endoscopic Spine Surgery, Athens Medical Center, Athens, PC 15124, Greece

Nikolaos Gkantsinikoudis, PhD Candidate

Role: STUDY_CHAIR

Spine Department and Deformities, Interbalkan European Medical Center, Thessaloniki, PC 55535, Greece

Aristeidis Kritis, Associate Professor

Role: STUDY_CHAIR

Department of Physiology and Pharmacology, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki (A.U.Th), Thessaloniki, PC 54124, Greece

Central Contacts

Stylianos Kapetanakis, Assistant Professor

Role: CONTACT

stkapetanakis@yahoo.gr

+306972707384

References

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Reference Type: BACKGROUND

PMID: 30881089 (View on PubMed)

Cheng J, Santiago KA, Nguyen JT, Solomon JL, Lutz GE. Treatment of symptomatic degenerative intervertebral discs with autologous platelet-rich plasma: follow-up at 5-9 years. Regen Med. 2019 Sep;14(9):831-840. doi: 10.2217/rme-2019-0040. Epub 2019 Aug 29.

Reference Type: BACKGROUND

PMID: 31464577 (View on PubMed)

Hirase T, Jack Ii RA, Sochacki KR, Harris JD, Weiner BK. Systemic Review: Is an Intradiscal Injection of Platelet-Rich Plasma for Lumbar Disc Degeneration Effective? Cureus. 2020 Jun 25;12(6):e8831. doi: 10.7759/cureus.8831.

Reference Type: BACKGROUND

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Wu J, Du Z, Lv Y, Zhang J, Xiong W, Wang R, Liu R, Zhang G, Liu Q. A New Technique for the Treatment of Lumbar Facet Joint Syndrome Using Intra-articular Injection with Autologous Platelet Rich Plasma. Pain Physician. 2016 Nov-Dec;19(8):617-625.

Reference Type: BACKGROUND

PMID: 27906940 (View on PubMed)

Wu J, Zhou J, Liu C, Zhang J, Xiong W, Lv Y, Liu R, Wang R, Du Z, Zhang G, Liu Q. A Prospective Study Comparing Platelet-Rich Plasma and Local Anesthetic (LA)/Corticosteroid in Intra-Articular Injection for the Treatment of Lumbar Facet Joint Syndrome. Pain Pract. 2017 Sep;17(7):914-924. doi: 10.1111/papr.12544. Epub 2017 Feb 22.

Reference Type: BACKGROUND

PMID: 27989008 (View on PubMed)

Aufiero D, Vincent H, Sampson S, Bodor M. Regenerative Injection Treatment in the Spine: Review and Case Series with Platelet Rich Plasma. J Stem Cells Res, Rev & Rep. 2015;2(1):1019.

Reference Type: BACKGROUND

Levi D, Horn S, Tyszko S, Levin J, Hecht-Leavitt C, Walko E. Intradiscal Platelet-Rich Plasma Injection for Chronic Discogenic Low Back Pain: Preliminary Results from a Prospective Trial. Pain Med. 2016 Jun;17(6):1010-22. doi: 10.1093/pm/pnv053. Epub 2015 Dec 26.

Reference Type: BACKGROUND

PMID: 26814283 (View on PubMed)

Kirchner F, Anitua E. Intradiscal and intra-articular facet infiltrations with plasma rich in growth factors reduce pain in patients with chronic low back pain. J Craniovertebr Junction Spine. 2016 Oct-Dec;7(4):250-256. doi: 10.4103/0974-8237.193260.

Reference Type: BACKGROUND

PMID: 27891035 (View on PubMed)

Navani A, Hames A. Platelet-rich plasma injections for lumbar discogenic pain: A preliminary assessment of structural and functional changes. Techniques in Regional Anesthesia and Pain Management 2015;19(1-2):38-44.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

Not administered

Identifier Type: -

Identifier Source: org_study_id