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

December 4, 2025 updated by: Dr. Mustafa A Hammad, Allmed Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quantifying pain intensity using Numeric Pain Scale (NPS)
Time Frame: 0-6 months
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)
Time Frame: 0-6 months
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)
Time Frame: 0-6 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessing adverse events from treatment
Time Frame: 0-6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allmed Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mustafa A Hammad, MD, Allmed Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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