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

The Efficacy and Safety of Platelet Rich Plasma Spinoplasty in the Management of Lower Back Pain Due to Multiple Pathologies: A Quasi-Experimental Study

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Disc Disease; Facet Joint Arthritis; Lower Back Pain Chronic
• Intervention / Treatment: Biological: Spinoplasty with Platelet Rich Plasma

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• Palestinian Territories
  • Ramallah, Palestinian Territories
    • Allmed Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Biological: 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).; Other Names: Trigger Point Injection; Epidural injection; Facet Joint Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantifying pain intensity using Numeric Pain Scale (NPS)	An 11-point scale (0 = no pain, 10 = worst imaginable pain) used to quantify pain intensity	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)	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	0-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-6 months

Collaborators and Investigators

• Sponsor: Allmed Medical Center
• Investigators: Principal Investigator: Mustafa A Hammad, MD, Allmed Medical Center

Publications and helpful links

Helpful Links

• Machado ES, Ambach MA, Caldas JM, Wei JJ, Bredemeier M. Personalized multitarget biologic injection in the spine: prospective case series of multitarget platelet-rich plasma for low back pain. Regen Med. 2022;17(1):11-22
• Zhang X et al. The Clinical Efficacy of Platelet-Rich Plasma Injection Therapy versus Different Control Groups for Chronic Low Back Pain: A Network Meta-Analysis of Randomized Controlled Trials. J Pain Res. 2024;17:1077-1089
• Muthu S, Viswanathan VK, Gangadaran P. Is platelet-rich plasma better than steroids as epidural drug of choice in lumbar disc disease with radiculopathy? Meta-analysis of randomized controlled trials. Exp Biol Med. 2025;Volume 250
• Mohammed S, Yu J. Platelet-rich plasma injections: an emerging therapy for chronic discogenic low back pain. J Spine Surg. 2018;4(1):115
• Baltzer AW, Enneper J, Baltzer LM, Godde G. Platelet Rich Plasma for the Therapy of the Lumbar Facet Joint Syndrome: A Prospective Study About CT-Guided Facet Joint Injections With PRP Compared to Local Anesthetics. Orthop Rev (Pavia). 2025;17:141416
• Xuan Z, Yu W, Dou Y, Wang T. Efficacy of Platelet-rich Plasma for Low Back Pain: A Systematic Review and Meta-analysis. J Neurol Surgery, Part A Cent Eur Neurosurg. 2020;81(6):529-534

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Platelet Rich Plasma; Lower back pain; lumbar disc disease
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain; Intervertebral disc disease; Therapeutics; Drug Administration Routes; Drug Therapy; Injections; Injections, Spinal; Injections, Epidural
• Other Study ID Numbers: HC.MRC.March4222024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) that underlie the reported results (de-identified clinical and demographic variables) will be made available to qualified researchers upon reasonable request. All shared data will be fully anonymized in accordance with institutional and ethical guidelines. No direct identifiers will be included.
• IPD Sharing Time Frame: Data will be made available following the publication of the primary manuscript. The data will remain available for a period of 5 years following publication.
• IPD Sharing Access Criteria: Data will be shared with qualified academic researchers for legitimate research purposes (e.g., meta-analysis, verification of findings). Requests must be sent to the corresponding author (Mustafa A. Hammad at neuro711@gmail.com). Requesters will need to provide a brief research proposal and sign a data use agreement (DUA) to ensure patient confidentiality is maintained.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No