NCT07528794

Ultrasound-Guided Lumbar Facet Joint Injections for Facet-Related Pain: A Randomized Comparison of Saline, Steroid, and 5% Dextrose

Prolotherapy for Lumbar Facet Joint-Related Low Back Pain: A Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Other Government
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the effectiveness of prolotherapy using 5% dextrose compared to steroid and saline injections in patients with lumbar facet joint-related low back pain. The study is designed as a randomized, double-blind clinical trial conducted in a tertiary physical medicine and rehabilitation center. Participants will be randomly assigned to receive one of the three treatments. Clinical outcomes including pain intensity, functional status, and physical performance will be assessed at baseline, 1 month, and 3 months. The results of this study may help determine the short-term effectiveness of prolotherapy as a treatment option for chronic low back pain.

Detailed description

Lumbar facet joint osteoarthritis is a significant contributor to chronic low back pain and is associated with functional limitation and reduced quality of life. Interventional treatment options such as corticosteroid injections are commonly used; however, alternative approaches such as prolotherapy have gained attention due to their potential regenerative and neuromodulatory effects. This study is a prospective, randomized, double-blind clinical trial designed to compare the effectiveness of 5% dextrose prolotherapy with steroid and saline injections in patients with chronic low back pain predominantly related to lumbar facet joint osteoarthritis. A total of 60 patients with symptoms lasting at least three months and inadequate response to conservative treatment are included. Participants are randomly allocated into three groups (1:1:1) using a computer-generated block randomization method. All participants undergo ultrasound-guided bilateral facet joint injections at L2-3, L3-4, L4-5, and L5-S1 levels with a standardized volume per joint. Outcome measures include pain intensity assessed by the Visual Analog Scale (VAS), functional status evaluated using the Oswestry Disability Index (ODI), and physical performance tests such as the Fingertip-to-Floor Test, 6-Minute Walk Test, and Milgram test. Assessments are performed at baseline, 1 month, and 3 months. The primary objective of this study is to evaluate the short-term clinical effectiveness of prolotherapy compared to steroid and placebo injections in lumbar facet joint-related low back pain.

Conditions

• Chronic Low Back Pain
• Lumbar Facet Joint Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	Dextrose Injection	Ultrasound-guided lumbar facet joint injection with 5% dextrose (1 mL per joint) administered bilaterally at L2-3, L3-4, L4-5, and L5-S1 levels (total 8 mL per participant).
PROCEDURE	Steroid Injection	Ultrasound-guided lumbar facet joint injection with dexamethasone phosphate (2 mg/mL, 1 mL per joint) administered bilaterally at L2-3, L3-4, L4-5, and L5-S1 levels (total 8 mL per participant).
PROCEDURE	Saline Injection	Ultrasound-guided lumbar facet joint injection with 0.9% saline (1 mL per joint) administered bilaterally at L2-3, L3-4, L4-5, and L5-S1 levels (total 8 mL per participant).

Timeline

• Start date: 2021-04-02
• Primary completion: 2023-03-17
• Completion: 2023-03-17
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: Turkey (Türkiye)