An interventional study of Ultrasound-Guided ESP Block and Thoracolumbar Fascia Interfascial Injection in Chronic Low Back Pain, sponsored by Damla Yürük. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Damla Yürük · Not applicable, Interventional, and Treatment
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.
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:
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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 72 is above the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Damla Yürük is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Ultrasound-Guided ESP Block
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.
Procedure: Thoracolumbar Fascia Interfascial Injection
Ultrasound-guided erector spinae plane block performed at the L3 transverse process level on the symptomatic side, with two treatment sessions one week apart.
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.
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.
Time frame: Baseline, 1 month, and 3 months after the second intervention
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.
Time frame: Baseline, 1 month, and 3 months after the second intervention
Plan to share: 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.
Start is estimated for Nov 2026; primary completion for Feb 2028, 15 months later.
Of 1,231 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 15 months is above that.
Counting every sponsor, half of 1,286 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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