Status:
UNKNOWN
Intradiscal and Intra-articular Injection of Autologous Platelet-Rich-Plasma (PRP) in Patients With Lumbar Degenerative Disc Disease and Facet Joint Syndrome
Lead Sponsor:
Stylianos Kapetanakis
Collaborating Sponsors:
Aristotle University Of Thessaloniki
Conditions:
Degenerative Disc Disease
Facet Joint Syndrome
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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 muscu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04816747
Start Date
April 1 2022
End Date
October 1 2024
Last Update
March 23 2022
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