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

Allmed Medical Center35 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lower Back Pain Chronic Lumbar Disc Disease Facet Joint Arthritis

Interventions

Spinoplasty with Platelet Rich PlasmaBIOLOGICAL

The patient received a procedure called "Spinoplasty" which interlaminar epidural, facet joints and trigger point injection with Platelet Rich Plasma (PRP).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Allmed Medical Center

Ramallah, Palestinian Territories

Outcomes

Primary Outcomes

Quantifying pain intensity using Numeric Pain Scale (NPS)

An 11-point scale (0 = no pain, 10 = worst imaginable pain) used to quantify pain intensity

Time frame: 0-6 months

Assessing level of functional disability using Oswestry Disability Index (ODI)

A 10-item questionnaire assessing the level of functional disability due to low back pain. Scores are calculated from a raw point score of 0-52, with lower scores indicating less disability. The raw score corresponds to the following disability levels: 0-4 points (No disability), 5-14 points (Mild disability), 15-24 points (Moderate disability), 25-34 points (Severe disability), and 35-52 points (Completely disabled)

Time frame: 0-6 months

Assessing patient's condition using Single Assessment Numeric Evaluation (SANE)

A patient-reported global assessment score where patients rate their condition on a scale of 0-100%, comparing their current status to their pre-injury baseline

Time frame: 0-6 months

Secondary Outcomes

Assessing adverse events from treatment

Adverse events were monitored and systematically recorded at each follow-up contact. Patients were asked about any potential complications, including but not limited to severe post-procedural pain, signs of infection (fever, erythema, swelling), new or worsening neurological symptoms, or any other unexpected medical events. we use a checklist of possible complications questionnaire that patients were asked about during follow-ups.

Time frame: 0-6 months

Data from ClinicalTrials.gov

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