Chronic Low Back PainNCT07528794
Ultrasound-Guided Lumbar Facet Joint Injections for Facet-Related Pain: A Randomized Comparison of Saline, Steroid, and 5% Dextrose
A study testing Dextrose Injection, Steroid Injection and Saline Injection in people with Chronic Low Back Pain and Lumbar Facet Joint Osteoarthritis, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Chronic Low Back Pain, Lumbar Facet Joint Osteoarthritis
- What is being tested?
- Dextrose Injection, Steroid Injection and Saline Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Apr 2021to 17 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Istanbul Physical Therapy and Rehabilitation Training and Research Hospital
Istanbul, Istanbul, 34186
About this study
Official title: 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.
Read the 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.
- Being tested
- Dextrose Injection, Steroid Injection, Saline Injection
- Keywords
- Lumbar facet osteoarthritis, Prolotherapy, Ultrasound guided facet joint injection, Chronic low back paın
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose InjectionProcedure or surgery
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 InjectionProcedure or surgery
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 InjectionProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Procedure: Saline Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, and 3 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start2 Apr 2021
- Primary completion17 Mar 2023
- Study completion17 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zulal Zor, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- Zulal Zor Gumus, Medical Doctor, Principal investigator, University of Health Sciences, Istanbul Physical Therapy and Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528794
- Sponsor's protocol ID
- 2021/159 March 15, 2021
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) may be shared upon reasonable request, subject to institutional policies and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolotherapy for Lumbar Facet Joint-Related Low Back Pain: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07528794
- Acronym / sponsor ID
- 2021/159 March 15, 2021
- Keywords
- Lumbar facet osteoarthritis, Prolotherapy, Ultrasound guided facet joint injection, Chronic low back paın
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Prolotherapy Group | Experimental | Procedure: Dextrose InjectionParticipants 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). |
| Steroid Group | Active comparator | Procedure: Steroid InjectionParticipants 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). |
| Saline Group | Placebo comparator | Procedure: Saline InjectionParticipants 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). |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextrose InjectionUltrasound-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 or surgery | Prolotherapy Group |
| Steroid InjectionUltrasound-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 or surgery | Steroid Group |
| Saline InjectionUltrasound-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). | Procedure or surgery | Saline Group |
Primary outcome
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.
4 secondary outcomes
Change in functional disability (Oswestry Disability Index, ODI)
Time frame: Baseline, 1 month, and 3 months
Change in flexibility (Fingertip-to-Floor distance)
Time frame: Baseline, 1 month, and 3 months
Change in physical performance (6-Minute Walk Test)
Time frame: Baseline, 1 month, and 3 months
Change in lumbar stability (Milgram test)
Time frame: Baseline, 1 month, and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) may be shared upon reasonable request, subject to institutional policies and ethical considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zulal Zor Gumus, Medical Doctor principal investigator
University of Health Sciences, Istanbul Physical Therapy and Rehabilitation Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dextrose Injection, Steroid Injection and Saline Injection in people with Chronic Low Back Pain and Lumbar Facet Joint Osteoarthritis, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity (Visual Analog Scale, VAS) (time frame: Baseline, 1 month, and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.