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

Sponsor

Stylianos Kapetanakis (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04816747

Collaborator

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

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Degenerative Disc Disease Facet Joint Syndrome	Biological: Autologous PRP	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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.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)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: 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.

Arm

Intervention/Treatment

Experimental: 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.

Biological: 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.

Outcome Measures

Primary Outcome Measures

Change in Pain Visual Analogue Scale (VAS) Scores from baseline to post intervention during follow-up [VAS score is planned to be evaluated preoperatively, immediately after intervention, at 6 weeks and at 3,6,12 and 24 months postoperatively.]
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 [SF-36 questionnaire is planned to be evaluated preoperatively, immediately after intervention, at 6 weeks and at 3,6,12 and 24 months postoperatively.]
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 [Complications will be constantly recorded during the study immediately after intervention, at 6 weeks and at 3,6,12 and 24 months postoperatively.]
Safety of implemented procedure is designed to be determined via the record of frequency and kind of perioperative associated complications.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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.,

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Principal Investigator: Stylianos Kapetanakis, Assistant Professor, 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
Study Chair: Nikolaos Gkantsinikoudis, PhD Candidate, Spine Department and Deformities, Interbalkan European Medical Center, Thessaloniki, PC 55535, Greece
Study Chair: Aristeidis Kritis, Associate Professor, Department of Physiology and Pharmacology, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki (A.U.Th), Thessaloniki, PC 54124, Greece

Study Documents (Full-Text)

None provided.

More Information

Publications

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), European Interbalkan Medical Center

ClinicalTrials.gov Identifier:

NCT04816747

Other Study ID Numbers:

Not administered

First Posted:

Mar 25, 2021

Last Update Posted:

Mar 23, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by 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), European Interbalkan Medical Center

Platelet-rich-plasma

intradiscal

intra-articular

degenerative disc disease

facet joint syndrome

facet joint arthritis

Additional relevant MeSH terms:

Spinal Diseases

Intervertebral Disc Degeneration

Syndrome

Study Results

No Results Posted as of Mar 23, 2022