Chronic Low Back Pain, Lumbar Facet Joint Osteoarthritis
Conditions
Keywords
Lumbar facet osteoarthritis, Prolotherapy, Ultrasound guided facet joint injection, Chronic low back paın
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.
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.
Interventions
PROCEDUREDextrose 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).
PROCEDURESteroid 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).
PROCEDURESaline 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).
Sponsors
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity (Visual Analog Scale, VAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in functional disability (Oswestry Disability Index, ODI) | 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. |
| Change in flexibility (Fingertip-to-Floor distance) | 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. |
| Change in physical performance (6-Minute Walk Test) | 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. |
| Change in lumbar stability (Milgram test) | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORZulal Zor Gumus, Medical Doctor
University of Health Sciences, Istanbul Physical Therapy and Rehabilitation Training and Research Hospital
Outcome results
None listed