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Completed

NCT Number: NCT07528794

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

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Istanbul, 34186, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

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).

Primary outcomes

  1. Change in pain intensity (Visual Analog Scale, VAS)

    Time frame: Baseline, 1 month, and 3 months

    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.

Secondary outcomes

  1. Change in functional disability (Oswestry Disability Index, ODI)

    Time frame: Baseline, 1 month, and 3 months

    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.

  2. Change in flexibility (Fingertip-to-Floor distance)

    Time frame: Baseline, 1 month, and 3 months

    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.

  3. Change in physical performance (6-Minute Walk Test)

    Time frame: Baseline, 1 month, and 3 months

    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.

  4. Change in lumbar stability (Milgram test)

    Time frame: Baseline, 1 month, and 3 months

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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