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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain; Lumbar Facet Joint Osteoarthritis
• Intervention / Treatment: Procedure: Dextrose Injection; Procedure: Steroid Injection; Procedure: Saline Injection

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34186
      • University of Health Sciences, Istanbul Physical Therapy and Rehabilitation Training and Research Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Adults aged 40-70 years Chronic low back pain lasting at least 3 months Inadequate response to at least 2 months of conservative treatment Predominantly axial low back pain aggravated by lumbar extension and rotation Absence of radicular symptoms No objective neurological deficits on physical examination

Clinical findings consistent with facet-mediated pain, including:

Localized facet joint tenderness Positive Kemp (lumbar extension-rotation) test Supportive positive Milgram test MRI evidence of lumbar facet joint osteoarthritis (L2-3 to L5-S1), including degenerative changes such as joint space narrowing, osteophytes, subchondral sclerosis, or facet hypertrophy

Exclusion Criteria:

• Significant lumbar disc herniation with nerve root compression Central canal or foraminal stenosis Vertebral fractures Inflammatory spinal diseases (e.g., spondyloarthritis) Predominant discogenic or vertebrogenic pain Neurogenic claudication Spinal deformities Objective neurological deficits Systemic inflammatory or neurological disorders Severe comorbid conditions that may affect functional outcomes Previous lumbar spinal interventions or injections Pregnancy Any other condition that may interfere with study participation or outcome assessment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prolotherapy Group; Participants receive ultrasound-guided bilateral lumbar facet joint injections with 5% dextrose (1 mL per joint) at L2-3, L3-4, L4-5, and L5-S1 levels (total 8 mL per participant).	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).
Active Comparator: Steroid Group; Participants receive ultrasound-guided bilateral lumbar facet joint injections with dexamethasone phosphate (2 mg/mL, 1 mL per joint) 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).
Placebo Comparator: Saline Group; Participants receive ultrasound-guided bilateral lumbar facet joint injections with 0.9% saline (1 mL per joint) 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain intensity (Visual Analog Scale, VAS)	Pain intensity is assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Changes from baseline are evaluated at 1-month and 3-month follow-up visits.	Baseline, 1 month, and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in functional disability (Oswestry Disability Index, ODI)	Functional disability is assessed using the Oswestry Disability Index (ODI), a validated questionnaire ranging from 0 to 100, with higher scores indicating greater disability. Changes from baseline are evaluated at 1-month and 3-month follow-up visits.	Baseline, 1 month, and 3 months
Change in flexibility (Fingertip-to-Floor distance)	Flexibility is assessed using the Fingertip-to-Floor Test, which measures the distance between the fingertips and the floor in centimeters during forward flexion. Lower values indicate better flexibility.	Baseline, 1 month, and 3 months
Change in physical performance (6-Minute Walk Test)	Physical performance is assessed using the 6-Minute Walk Test, measuring the distance walked in meters over six minutes. Greater distances indicate better functional capacity.	Baseline, 1 month, and 3 months
Change in lumbar stability (Milgram test)	Lumbar stability is assessed using the Milgram test, which evaluates the ability to maintain bilateral leg elevation in a supine position. Improvement is defined as increased ability to maintain the position without pain.	Baseline, 1 month, and 3 months

Collaborators and Investigators

• Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Investigators: Principal Investigator: Zulal Zor Gumus, Medical Doctor, University of Health Sciences, Istanbul Physical Therapy and Rehabilitation Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2021
• Primary Completion (Actual): March 17, 2023
• Study Completion (Actual): March 17, 2023

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Prolotherapy; Lumbar facet osteoarthritis; Ultrasound guided facet joint injection; Chronic low back paın
• Additional Relevant MeSH Terms: Carbohydrates; Polycyclic Compounds; Inorganic Chemicals; Chlorine Compounds; Fused-Ring Compounds; Sugars; Sodium Compounds; Hexoses; Monosaccharides; Chlorides; Hydrochloric Acid; Steroids; Glucose; Sodium Chloride
• Other Study ID Numbers: 2021/159 March 15, 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data (IPD) may be shared upon reasonable request, subject to institutional policies and ethical considerations.

Drug and device information, study documents

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