ESP-TLF
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
Sponsor study identifier
interventional
72
1 country
1
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
February 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 21, 2026
Actual (reported)October 28, 2026
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Baseline, 1 month, and 3 months after the second intervention
Change in Oswestry Disability Index (ODI) Score
Baseline, 1 month, and 3 months after the second intervention
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.
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.
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.
Ankara Etlik City Hospital
Ankara, Ankara, 06500, Turkey (Türkiye)
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.
Pirri 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.
AYSE BETUL ACAR
Ankara Etlik City Hospital
First Submitted
October 21, 2026
First Posted
October 28, 2026
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Effectiveness of Electrotherapy Treatment in Chronic Low Back Pain
Contact the study team to confirm eligibility.
Chin 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.
Primary Completion
February 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 28, 2026
Record last verified: 2026-10
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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Source: ClinicalTrials.gov.
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