Clinical Trials Directory

Trials / Completed

CompletedNCT07268885

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
35 (actual)
Sponsor
Allmed Medical Center · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

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

Timeline

Start date
2024-09-15
Primary completion
2025-03-01
Completion
2025-09-01
First posted
2025-12-08
Last updated
2025-12-08

Locations

1 site across 1 country: Palestinian Territories

Source: ClinicalTrials.gov record NCT07268885. Inclusion in this directory is not an endorsement.