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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-15

Study Completion Date

2025-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lower Back Pain Chronic Lumbar Disc Disease Facet Joint Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

Spinoplasty with Platelet Rich Plasma

Intervention Type BIOLOGICAL

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

Interventions

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Spinoplasty with Platelet Rich Plasma

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Epidural injection Facet Joint Injection Trigger Point Injection

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No