Chronic Low Back PainESP-TLFNCT07900347
Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain
A study testing Ultrasound-Guided ESP Block and Thoracolumbar Fascia Interfascial Injection in people with Chronic Low Back Pain, run by Damla Yürük at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate whether adding a thoracolumbar fascia (TLF) interfascial injection to an erector spinae plane (ESP) block improves pain relief and functional outcomes in patients with chronic axial low back pain. A total of 72 patients will be randomly assigned to one of two groups. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Ultrasound-Guided ESP Block and Thoracolumbar Fascia Interfascial Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years
- Chronic low back pain lasting at least 3 months
- Diagnosis of nonspecific chronic axial low back pain based on clinical evaluation and available imaging findings
- No specific spinal, neurological, inflammatory, infectious, or malignant pathology explaining the pain
- Baseline Visual Analog Scale (VAS) pain score >4
- Clinically identifiable symptomatic side with more pronounced pain
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- Inadequate pain relief despite conservative treatment
- Ability to attend both intervention sessions and follow-up visits
- Willingness to participate and provision of written informed consent
Who cannot join
- Significant lumbar disc herniation or radiculopathy
- Spinal stenosis, spondylolisthesis, or advanced degenerative spinal disease
- Vertebral fracture, spinal infection, malignancy, or inflammatory rheumatic disease
- Polyneuropathy or other neurological conditions affecting assessment
- Fibromyalgia or widespread pain syndrome
- Previous lumbar spine surgery
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- Active systemic infection or infection at the injection site
- Coagulation disorders or anticoagulant/antiplatelet therapy that cannot be appropriately managed for the procedure
- Known allergy to lidocaine or dexamethasone
- Uncontrolled diabetes mellitus or hypertension
- Severe hepatic, renal, or cardiac disease
- Local anesthetic or steroid-containing interventional treatment in the lumbar region within the previous 3 months
- Cognitive or psychiatric conditions preventing reliable completion of assessment scales
- Inability to comply with the study protocol or follow-up visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Ankara, 06500
AYSE BETUL ACAR, 05326685180, betulbozann@gmail.com
AYSE BETUL ACAR
About this study
Official title: Effects of Adding Thoracolumbar Fascia Interfascial Injection to Erector Spinae Plane Block on Pain and Functional Outcomes in Patients With Chronic Axial Low Back Pain: A Prospective Randomized Controlled Trial
This study aims to investigate whether adding a thoracolumbar fascia (TLF) interfascial injection to an erector spinae plane (ESP) block improves pain relief and functional outcomes in patients with chronic axial low back pain.
A total of 72 patients will be randomly assigned to one of two groups. The first group will receive ultrasound-guided ESP blocks alone, while the second group will receive ultrasound-guided ESP blocks combined with TLF interfascial injections. Both groups will undergo two treatment sessions one week apart.
Pain intensity, functional disability, analgesic consumption, treatment success, and adverse events will be evaluated during a three-month follow-up period.
Read the detailed description
Chronic axial low back pain is a common condition associated with persistent pain, functional limitations, and reduced quality of life. Ultrasound-guided erector spinae plane (ESP) block and thoracolumbar fascia (TLF) interfascial injection are regional interventional techniques that may provide pain relief in patients with chronic low back pain.
This prospective, randomized, controlled, single-center study will include 72 patients aged 18-65 years with nonspecific chronic axial low back pain lasting at least three months and an inadequate response to conservative treatments.
Eligible participants will be randomly allocated in a 1:1 ratio to two parallel groups:
- Group 1 (Active Comparator): Ultrasound-guided ESP block alone.
- Group 2 (Experimental): Ultrasound-guided ESP block combined with TLF interfascial injection.
All interventions will be performed on the symptomatic side at the L3 transverse process level. Each participant will receive two treatment sessions at a one-week interval.
Pain intensity will be assessed using the Visual Analog Scale (VAS), and functional disability will be evaluated using the Oswestry Disability Index (ODI). Additional outcomes will include analgesic consumption, treatment success, need for additional treatment, and procedure-related adverse events.
Participants will be evaluated at baseline, one week, and at one and three months after the second intervention.
The study aims to determine whether adding TLF interfascial injection to ESP block provides additional clinical benefits compared with ESP block alone in patients with chronic axial low back pain.
- Conditions
- Chronic Low Back Pain
- Being tested
- Ultrasound-Guided ESP Block, Thoracolumbar Fascia Interfascial Injection
- Keywords
- Chronic Axial Low Back Pain, Erector Spinae Plane Block, Thoracolumbar Fascia, Interfascial Injection, Ultrasound-Guided Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided ESP BlockProcedure or surgery
Ultrasound-guided erector spinae plane block performed at the L3 transverse process level on the symptomatic side, with two treatment sessions one week apart.
Thoracolumbar Fascia Interfascial InjectionProcedure or surgery
Ultrasound-guided thoracolumbar fascia interfascial injection administered in addition to the erector spinae plane block on the symptomatic side, with two treatment sessions one week apart.
| Study group | Role | What they receive |
|---|---|---|
| ESP Block Alone | Active comparator | Participants will receive ultrasound-guided erector spinae plane (ESP) block on the symptomatic side at the L3 transverse process level. Two treatment sessions will be performed one week apart. Receives: Procedure: Ultrasound-Guided ESP Block |
| ESP Block Plus TLF Injection | Active comparator | Participants will receive ultrasound-guided erector spinae plane (ESP) block combined with thoracolumbar fascia (TLF) interfascial injection on the symptomatic side at the L3 level. Two treatment sessions will be performed one week apart. Receives: Procedure: Thoracolumbar Fascia Interfascial Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale (VAS) Pain Score
Pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Changes in VAS scores from baseline to 1 month and 3 months after the second intervention will be evaluated and compared between the two treatment groups. Greater reductions in VAS scores indicate better pain relief.
Measured: Baseline, 1 month, and 3 months after the second intervention
Secondary outcomes (1)
Change in Oswestry Disability Index (ODI) Score
Functional disability will be assessed using the Oswestry Disability Index (ODI), with scores ranging from 0 to 100. Higher scores indicate greater disability. Changes in ODI scores from baseline to 1 month and 3 months after the second intervention will be evaluated and compared between the two treatment groups. Greater reductions indicate better functional improvement.
Measured: Baseline, 1 month, and 3 months after the second intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 will be randomly assigned in a 1:1 ratio to two parallel groups: ultrasound-guided erector spinae plane block alone or erector spinae plane block combined with thoracolumbar fascia interfascial injection. Kopyala
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Damla Yürük
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Damla Yürük, Diskapi Teaching and Research Hospital
- Investigators
- AYSE BETUL ACAR, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900347
- Sponsor's protocol ID
- ESP-TLF-RCT-2026
- Acronym
- ESP-TLF
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a prospective, single-center, randomized, open-label, parallel-group controlled trial. A total of 72 participants will be randomly allocated in a 1:1 ratio to receive either ultrasound-guided erector spinae plane (ESP) block alone or ESP block combined with thoracolumbar fascia (TLF) interfascial injection. Both groups will receive two intervention sessions one week apart. Pain intensity and functional outcomes will be assessed at baseline and at 1 and 3 months after the second intervention.
Publications
Okmen BM, Okmen K. Effectiveness of the Ultrasound-Guided Interfascial Injection Applied in Addition to Physical Therapy Applications in Chronic Low Back Pain: A Quasi-Experimental Study. Eurasian J Med. 2024 Feb;56(1):56-60. doi: 10.5152/eurasianjmed.2024.23286.
PubMed 39128044Pirri C, Pirri N, Guidolin D, Macchi V, Porzionato A, De Caro R, Stecco C. Ultrasound Imaging of Thoracolumbar Fascia Thickness: Chronic Non-Specific Lower Back Pain versus Healthy Subjects; A Sign of a "Frozen Back"? Diagnostics (Basel). 2023 Apr 16;13(8):1436. doi: 10.3390/diagnostics13081436.
PubMed 37189537Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6.
PubMed 33403545
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adding Thoracolumbar Fascia Interfascial Injection to Erector Spinae Plane Block on Pain and Functional Outcomes in Patients With Chronic Axial Low Back Pain: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07900347
- Acronym / sponsor ID
- ESP-TLF / ESP-TLF-RCT-2026
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic Axial Low Back Pain, Erector Spinae Plane Block, Thoracolumbar Fascia, Interfascial Injection, Ultrasound-Guided Block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Damla YürükUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 28 Oct 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 investigate whether adding a thoracolumbar fascia (TLF) interfascial injection to an erector spinae plane (ESP) block improves pain relief and functional outcomes in patients with chronic axial low back pain.
A total of 72 patients will be randomly assigned to one of two groups. The first group will receive ultrasound-guided ESP blocks alone, while the second group will receive ultrasound-guided ESP blocks combined with TLF interfascial injections. Both groups will undergo two treatment sessions one week apart.
Pain intensity, functional disability, analgesic consumption, treatment success, and adverse events will be evaluated during a three-month follow-up period.
Detailed description
Chronic axial low back pain is a common condition associated with persistent pain, functional limitations, and reduced quality of life. Ultrasound-guided erector spinae plane (ESP) block and thoracolumbar fascia (TLF) interfascial injection are regional interventional techniques that may provide pain relief in patients with chronic low back pain.
This prospective, randomized, controlled, single-center study will include 72 patients aged 18-65 years with nonspecific chronic axial low back pain lasting at least three months and an inadequate response to conservative treatments.
Eligible participants will be randomly allocated in a 1:1 ratio to two parallel groups:
- Group 1 (Active Comparator): Ultrasound-guided ESP block alone.
- Group 2 (Experimental): Ultrasound-guided ESP block combined with TLF interfascial injection.
All interventions will be performed on the symptomatic side at the L3 transverse process level. Each participant will receive two treatment sessions at a one-week interval.
Pain intensity will be assessed using the Visual Analog Scale (VAS), and functional disability will be evaluated using the Oswestry Disability Index (ODI). Additional outcomes will include analgesic consumption, treatment success, need for additional treatment, and procedure-related adverse events.
Participants will be evaluated at baseline, one week, and at one and three months after the second intervention.
The study aims to determine whether adding TLF interfascial injection to ESP block provides additional clinical benefits compared with ESP block alone in patients with chronic axial low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to two parallel groups: ultrasound-guided erector spinae plane block alone or erector spinae plane block combined with thoracolumbar fascia interfascial injection. Kopyala
| Arm | Type | Receives |
|---|---|---|
| ESP Block Alone | Active comparator | Procedure: Ultrasound-Guided ESP BlockParticipants will receive ultrasound-guided erector spinae plane (ESP) block on the symptomatic side at the L3 transverse process level. Two treatment sessions will be performed one week apart. |
| ESP Block Plus TLF Injection | Active comparator | Procedure: Thoracolumbar Fascia Interfascial InjectionParticipants will receive ultrasound-guided erector spinae plane (ESP) block combined with thoracolumbar fascia (TLF) interfascial injection on the symptomatic side at the L3 level. Two treatment sessions will be performed one week apart. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults aged 18-65 years
- Chronic low back pain lasting at least 3 months
- Diagnosis of nonspecific chronic axial low back pain based on clinical evaluation and available imaging findings
- No specific spinal, neurological, inflammatory, infectious, or malignant pathology explaining the pain
- Baseline Visual Analog Scale (VAS) pain score >4
Key exclusion criteria (14 listed)
- Significant lumbar disc herniation or radiculopathy
- Spinal stenosis, spondylolisthesis, or advanced degenerative spinal disease
- Vertebral fracture, spinal infection, malignancy, or inflammatory rheumatic disease
- Polyneuropathy or other neurological conditions affecting assessment
- Fibromyalgia or widespread pain syndrome
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 |
|---|---|---|
| Ultrasound-Guided ESP BlockUltrasound-guided erector spinae plane block performed at the L3 transverse process level on the symptomatic side, with two treatment sessions one week apart. | Procedure or surgery | ESP Block Alone |
| Thoracolumbar Fascia Interfascial InjectionUltrasound-guided thoracolumbar fascia interfascial injection administered in addition to the erector spinae plane block on the symptomatic side, with two treatment sessions one week apart. | Procedure or surgery | ESP Block Plus TLF Injection |
Primary outcome
Change in Visual Analog Scale (VAS) Pain Score
Time frame: Baseline, 1 month, and 3 months after the second intervention
Pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Changes in VAS scores from baseline to 1 month and 3 months after the second intervention will be evaluated and compared between the two treatment groups. Greater reductions in VAS scores indicate better pain relief.
1 secondary outcome
Change in Oswestry Disability Index (ODI) Score
Time frame: Baseline, 1 month, and 3 months after the second intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Results publication: PubMed 39128044Okmen BM, Okmen K. Effectiveness of the Ultrasound-Guided Interfascial Injection Applied in Addition to Physical Therapy Applications in Chronic Low Back Pain: A Quasi-Experimental Study. Eurasian J Med. 2024 Feb;56(1):56-60. doi: 10.5152/eurasianjmed.2024.23286.
- Results publication: PubMed 37189537Pirri C, Pirri N, Guidolin D, Macchi V, Porzionato A, De Caro R, Stecco C. Ultrasound Imaging of Thoracolumbar Fascia Thickness: Chronic Non-Specific Lower Back Pain versus Healthy Subjects; A Sign of a "Frozen Back"? Diagnostics (Basel). 2023 Apr 16;13(8):1436. doi: 10.3390/diagnostics13081436.
- Results publication: PubMed 33403545Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6.
- Individual participant dataSharing planned: No. This is a prospective, single-center, randomized, open-label, parallel-group controlled trial. A total of 72 participants will be randomly allocated in a 1:1 ratio to receive either ultrasound-guided erector spinae plane (ESP) block alone or ESP block combined with thoracolumbar fascia (TLF) interfascial injection. Both groups will receive two intervention sessions one week apart. Pain intensity and functional outcomes will be assessed at baseline and at 1 and 3 months after the second intervention.
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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.
AYSE BETUL ACAR principal investigator
Ankara Etlik City 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 Ultrasound-Guided ESP Block and Thoracolumbar Fascia Interfascial Injection in people with Chronic Low Back Pain, run by Damla Yürük 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 9 inclusion and 14 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: opening soon, as of the sponsor's last update on 28 Oct 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AYSE BETUL ACAR, MD (05326685180, betulbozann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (VAS) Pain Score (time frame: Baseline, 1 month, and 3 months after the second intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07900347, which also lists 3 linked publications.
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 28 Oct 2026.