PRP Spinoplasty for Chronic Low Back Pain With Multiple Pathologies: A Quasi-Experimental Study

Allmed Medical Center

Status and phase: Completed; Phase 2

Conditions: Lower Back Pain Chronic; Facet Joint Arthritis; Lumbar Disc Disease

Treatments: Biological: Spinoplasty with Platelet Rich Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT07268885

HC.MRC.March4222024

Details and patient eligibility

About

This study aimed to evaluate the efficacy and safety of a comprehensive, multi-target injection protocol, termed 'PRP Spinoplasty,' for managing chronic LBP stemming from concurrent lumbar disc and facet joint disease with associated muscle spasms.

Full description

A quasi-experimental study was conducted on 29 patients with chronic LBP who failed conservative therapy. The PRP Spinoplasty protocol involved a single-session, fluoroscopy-guided administration of autologous PRP to the interlaminar epidural space, affected facet joints, and paraspinal muscle trigger points. Outcomes were assessed using the Numeric Pain Scale (NPS), Oswestry Disability Index (ODI), and Single Assessment Numeric Evaluation (SANE) at baseline and at 1 week, 1 month, 3 months, and 6 months post-procedure.

Enrollment: 35 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals of both sexes; ages between 18 and 80 years.
• Lower back pain consistent with lumbosacral radiculopathy, facet arthropathy, and muscle spasms.
• MRI-confirmed lumbar spine pathology (disc disease and/or facet arthropathy).
• Failure to respond to at least 3 months of conservative therapy (NSAIDS and physical therapy).
• Pain score ≥ 6; on the 10-point Numeric Pain Scale (NPS) at baseline.

Exclusion criteria

• Presence of local or systemic infection, or fever.
• Diagnosed with cancer within the past 12 months.
• Unable to give a consent.
• History of spinal deformity such as fracture, or severe spinal stenosis causing neurological deficit.
• Presence of lower extremity weakness or urinary tract symptoms related to spinal pathology.
• Previous spinal decompression or fusion surgery at the treatment level.
• Receipt of any spine injection within the previous 12 months.
• Use of NSAIDs within 2 weeks prior to, or 6 weeks following the procedure.
• Use of corticosteroids within 6 weeks prior, or after the procedure.
• Use of anticoagulation or antiplatelet drugs (excluding low-dose Aspirin).
• History of blood disorders.
• History of any major surgery within the past 3 months.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Adult patients with chronic low back pain secondary to lumbar disc disease and facet arthropathy

Experimental group

Description:

The study population consisted of 35 adult patients with a diagnosis of chronic low back pain secondary to lumbar disc disease and facet arthropathy, with an associated component of muscular spasm. Diagnoses were confirmed by an interventional pain specialist based on a detailed medical history, physical examination, and magnetic resonance imaging (MRI) findings.

Treatment:

Biological: Spinoplasty with Platelet Rich Plasma