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

Primary Purpose

Degenerative Disc Disease, Facet Joint Syndrome

Status

Not yet recruiting

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Autologous PRP

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Platelet-rich-plasma, intradiscal, intra-articular, degenerative disc disease, facet joint syndrome, facet joint arthritis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Eligibility criteria will be distinctly applied in participants with lumbar DDD and FJS prior to treatment application.

A. Participants with lumbar DDD

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)
Absence of exclusion criteria, as defined below.

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

Inclusion Criteria

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)
Absence of exclusion criteria, as designated below.

Exclusion Criteria

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous PRP

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Pain Visual Analogue Scale (VAS) Scores from baseline to post intervention during follow-up

Participants will be asked to indicate the pain level according to their subjective perception with as spot in a unipolar horizontal line of 100 mm (0: no pain, 100: the worst pain possible). Scores will be calculated in mm, and an one-decimal place approach will be adopted for record.

Alteration in Short-Form 36 (SF-36) Medical Health Survey Questionnaire Scores from baseline to post intervention during follow-up

Participants will be asked to complete the analogous questionnaire, so that eight distinct parameters reflecting general health status are evaluated: physical function (PF), role-physical (RP), bodily pain (BP), general health (GH), energy, fatigue and vitality (V), social function (SF), role-emotional (RE) and mental health (MH). Computational processing of collected data will be subsequently conducted, so that each parameter is expressed by a percentage. Greater scores in these 8 parameters are associated with ameliorated Health-Related Quality of Life (HRQoL).

Secondary Outcome Measures

Complications

Safety of implemented procedure is designed to be determined via the record of frequency and kind of perioperative associated complications.

Full Information

NCT ID

NCT04816747

First Posted

March 23, 2021

Last Updated

March 22, 2022

Sponsor

Stylianos Kapetanakis

Collaborators

School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki (A.U.Th.), Greece

1. Study Identification

Unique Protocol Identification Number

NCT04816747

Brief Title

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

Official Title

Intradiscal and Intra-articular Injection of Autologous Platelet-Rich-Plasma (PRP) in Patients With Lumbar Degenerative Disc Disease and Facet Joint Syndrome: A Prospective, Single-arm, Open Label Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 2022 (Anticipated)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Stylianos Kapetanakis

Collaborators

School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki (A.U.Th.), Greece

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Degenerative Disc Disease, Facet Joint Syndrome

Keywords

Platelet-rich-plasma, intradiscal, intra-articular, degenerative disc disease, facet joint syndrome, facet joint arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Model Description

All participants fulfilling the predetermined inclusion criteria will be considered eligible to be subjected to treatment with PRP. Injection of PRP will be conducted intradiscally and/or intra-articularly, in cases of lumbar DDD and/or FJS, as defined by clinical and radiologic assessment. Hence, all participants will be assigned to the same intervention.

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Autologous PRP

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Autologous PRP

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Pain Visual Analogue Scale (VAS) Scores from baseline to post intervention during follow-up

Description

Time Frame

VAS score is planned to be evaluated preoperatively, immediately after intervention, at 6 weeks and at 3,6,12 and 24 months postoperatively.

Title

Alteration in Short-Form 36 (SF-36) Medical Health Survey Questionnaire Scores from baseline to post intervention during follow-up

Description

Time Frame

SF-36 questionnaire is planned to be evaluated preoperatively, immediately after intervention, at 6 weeks and at 3,6,12 and 24 months postoperatively.

Secondary Outcome Measure Information:

Title

Complications

Description

Safety of implemented procedure is designed to be determined via the record of frequency and kind of perioperative associated complications.

Time Frame

Complications will be constantly recorded during the study immediately after intervention, at 6 weeks and at 3,6,12 and 24 months postoperatively.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Eligibility criteria will be distinctly applied in participants with lumbar DDD and FJS prior to treatment application. A. Participants with lumbar DDD 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) Absence of exclusion criteria, as defined below. 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 Inclusion Criteria 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) Absence of exclusion criteria, as designated below. Exclusion Criteria 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stylianos Kapetanakis, Assistant Professor

Phone

+306972707384

stkapetanakis@yahoo.gr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stylianos Kapetanakis, Assistant Professor

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nikolaos Gkantsinikoudis, PhD Candidate

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Aristeidis Kritis, Associate Professor

Organizational Affiliation

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

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30881089

Citation

Akeda K, Yamada J, Linn ET, Sudo A, Masuda K. Platelet-rich plasma in the management of chronic low back pain: a critical review. J Pain Res. 2019 Feb 25;12:753-767. doi: 10.2147/JPR.S153085. eCollection 2019.

Results Reference

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PubMed Identifier

31464577

Citation

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.

Results Reference

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PubMed Identifier

32607308

Citation

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.

Results Reference

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PubMed Identifier

27906940

Citation

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.

Results Reference

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PubMed Identifier

27989008

Citation

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.

Results Reference

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Citation

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.

Results Reference

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PubMed Identifier

26814283

Citation

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.

Results Reference

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PubMed Identifier

27891035

Citation

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.

Results Reference

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Citation

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.

Results Reference

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PubMed Identifier

26314234

Citation

Tuakli-Wosornu YA, Terry A, Boachie-Adjei K, Harrison JR, Gribbin CK, LaSalle EE, Nguyen JT, Solomon JL, Lutz GE. Lumbar Intradiskal Platelet-Rich Plasma (PRP) Injections: A Prospective, Double-Blind, Randomized Controlled Study. PM R. 2016 Jan;8(1):1-10; quiz 10. doi: 10.1016/j.pmrj.2015.08.010. Epub 2015 Aug 24.

Results Reference

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PubMed Identifier

28670405

Citation

Akeda K, Ohishi K, Masuda K, Bae WC, Takegami N, Yamada J, Nakamura T, Sakakibara T, Kasai Y, Sudo A. Intradiscal Injection of Autologous Platelet-Rich Plasma Releasate to Treat Discogenic Low Back Pain: A Preliminary Clinical Trial. Asian Spine J. 2017 Jun;11(3):380-389. doi: 10.4184/asj.2017.11.3.380. Epub 2017 Jun 15.

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PubMed Identifier

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Citation

Lutz GE. Increased Nuclear T2 Signal Intensity and Improved Function and Pain in a Patient One Year After an Intradiscal Platelet-Rich Plasma Injection. Pain Med. 2017 Jun 1;18(6):1197-1199. doi: 10.1093/pm/pnw299. No abstract available.

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PubMed Identifier

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Citation

Pfirrmann CW, Metzdorf A, Zanetti M, Hodler J, Boos N. Magnetic resonance classification of lumbar intervertebral disc degeneration. Spine (Phila Pa 1976). 2001 Sep 1;26(17):1873-8. doi: 10.1097/00007632-200109010-00011.

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PubMed Identifier

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Citation

Suri P, Katz JN, Rainville J, Kalichman L, Guermazi A, Hunter DJ. Vascular disease is associated with facet joint osteoarthritis. Osteoarthritis Cartilage. 2010 Sep;18(9):1127-32. doi: 10.1016/j.joca.2010.06.012. Epub 2010 Jul 13.

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

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