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

NCT07528794 | Completed

• 1 other identifier: 2021/159 March 15, 2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Low Back Pain; Lumbar Facet Joint Osteoarthritis

Keywords

Lumbar facet osteoarthritis; Prolotherapy; Ultrasound guided facet joint injection; Chronic low back paın

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in functional disability (Oswestry Disability Index, ODI)

  Baseline, 1 month, and 3 months

• Change in flexibility (Fingertip-to-Floor distance)

  Baseline, 1 month, and 3 months

• Change in physical performance (6-Minute Walk Test)

  Baseline, 1 month, and 3 months

• Change in lumbar stability (Milgram test)

  Baseline, 1 month, and 3 months

Study Arms (3)

Prolotherapy Group

EXPERIMENTAL

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

Steroid Group

ACTIVE COMPARATOR

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

Saline Group

PLACEBO COMPARATOR

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

Interventions

Dextrose Injection PROCEDURE

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).

Prolotherapy Group

Steroid Injection PROCEDURE

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).

Steroid Group

Saline Injection PROCEDURE

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).

Saline Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences, Istanbul Physical Therapy and Rehabilitation Training and Research Hospital

Istanbul, Istanbul, 34186, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Glucose; Steroids; Sodium Chloride

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Zulal Zor Gumus, Medical Doctor

  University of Health Sciences, Istanbul Physical Therapy and Rehabilitation Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Allocation concealment was achieved using identical opaque syringes labeled with participant codes. Syringes were prepared by an independent assistant who was not involved in outcome assessment or data analysis. Participants, care providers, investigators, and outcome assessors were blinded to group allocation throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Physical Medicine and Rehabilitation

Model Details: Participants are randomly assigned in a 1:1:1 ratio to three parallel groups to receive prolotherapy with 5% dextrose, steroid injection, or saline injection. Each participant receives only one type of intervention and remains in the assigned group throughout the study period.

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: April 2, 2021
• Primary Completion: March 17, 2023
• Study Completion: March 17, 2023
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

TU (1)