An interventional study of Ultrasound-Guided Thoracolumbar Fascia Injection and Standard Conservative Treatment in Chronic Low Back Pain and Type 2 Diabetes Mellitus (DM), sponsored by Hatice Zehra FERHATLAR. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Hatice Zehra FERHATLAR · Not applicable, Interventional, and Treatment
This prospective, randomized, controlled clinical trial aims to evaluate the efficacy of ultrasound-guided thoracolumbar fascia (TLF) injection as an adjunct to standard conservative treatment in patients with type 2 diabetes mellitus and chronic nonspecific low back pain.
A total of 60 patients aged 18-65 years, diagnosed with type 2 diabetes mellitus for at least one year and experiencing chronic nonspecific low back pain for at least three months, will be enrolled. Eligible participants will be randomly assigned to two groups. The intervention group will receive ultrasound-guided thoracolumbar fascia injection in addition to standard conservative treatment, while the control group will receive standard conservative treatment alone, consisting of patient education and a structured exercise program.
Clinical assessments will be performed at baseline and at 1 and 3 months after treatment. Treatment outcomes will include pain intensity measured using the Numeric Rating Scale (NRS), functional disability assessed using the Oswestry Disability Index (ODI), pressure pain threshold (PPT) measured by algometry, and analgesic consumption.
Thoracolumbar fascia thickness will be measured using ultrasonography at baseline to investigate its potential association with treatment response. Diabetes-related characteristics, including HbA1c levels, diabetes duration, and peripheral neuropathy status, will also be recorded.
The primary objective is to determine whether adding ultrasound-guided thoracolumbar fascia injection to standard conservative treatment provides greater improvement in pain intensity and functional disability compared with standard conservative treatment alone. The study will also explore whether baseline thoracolumbar fascia thickness and diabetes-related characteristics are associated with clinical outcomes.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Hatice Zehra FERHATLAR is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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**Inclusion Criteria:**
**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.
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.
Procedure: Ultrasound-Guided Thoracolumbar Fascia Injection · Behavioral: Standard Conservative Treatment
Behavioral: Standard Conservative Treatment
A single ultrasound-guided thoracolumbar fascia injection will be performed with the patient in the prone position under aseptic conditions. Using an in-plane technique, a 22-gauge needle will be advanced into the middle layer of the thoracolumbar fascia between the quadratus lumborum and erector spinae muscles at the L4 level. Correct needle placement will be confirmed by hydrodissection using approximately 2 mL of local anesthetic. Subsequently, 10 mL of 0.25% bupivacaine and 40 mg of methylprednisolone acetate will be administered into the interfascial plane.
Standard conservative treatment will consist of structured patient education and a home-based exercise program. The exercise program will include lumbopelvic and core stabilization exercises, abdominal and paraspinal muscle strengthening, hip muscle strengthening, lower extremity stretching, and aerobic activity as tolerated. Participants will receive instructions on correct exercise techniques, maintaining daily activities, and avoiding prolonged bed rest. The program will be recommended for regular home practice throughout the study period.
Change in Low Back Pain Intensity Measured by the Numeric Rating Scale (NRS)
Time frame: Baseline, Month 1, and Month 3
Change in Functional Disability Measured by the Oswestry Disability Index (ODI)
Time frame: Baseline, Month 1, and Month 3
Change in Pressure Pain Threshold (PPT) Measured by Algometry
Time frame: Baseline, Month 1, and Month 3
Change in Analgesic Consumption During Follow-up
Time frame: Baseline to Month 3
Plan to share: No
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 ↗
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Hatice Zehra FERHATLAR