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

NCT07268885 | Completed Phase 2

• 1 other identifier: HC.MRC.March4222024
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Platelet Rich Plasma; Lower back pain; lumbar disc disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Assessing adverse events from treatment

  0-6 months

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

Spinoplasty with Platelet Rich Plasma BIOLOGICAL

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

Also known as: Epidural injection, Facet Joint Injection, Trigger Point Injection

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allmed Medical Center: lead

Study Sites (1)

Allmed Medical Center

Ramallah, Palestinian Territories

Location

Related 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

MeSH Terms

Conditions

Intervertebral disc disease; Low Back Pain

Interventions

Injections, Epidural

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mustafa A Hammad, MD

  Allmed Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director and Principal Investigator

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 8, 2025
• Study Start: September 15, 2024
• Primary Completion: March 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

PA (1)