Ultrasound-Guided Thoracolumbar Fascia Injection for Chronic Low Back Pain in Type 2 Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, controlled trial will compare ultrasound-guided thoracolumbar fascia injections plus standard conservative treatment to standard conservative treatment alone in adults aged 18-65 with type 2 diabetes and chronic nonspecific low back pain. Participants will receive injections in addition to education and a structured exercise program, with assessments at baseline, 1 month, and 3 months measuring pain intensity and other outcomes. The study aims to determine if adding the injection provides greater pain relief than standard care alone. Enrollment targets 60 participants across a single center in Istanbul, Turkey. The lead sponsor is Hatice Zehra Ferhatlar, with no listed collaborators.

Why it matters

Who can join: the full rules

\*\*Inclusion Criteria:\*\*

* Age between 18 and 65 years.
* Diagnosis of type 2 diabetes mellitus for at least 1 year.
* Chronic low back pain lasting at least 3 months.
* Nonspecific or mechanical low back pain.
* Baseline pain intensity of ≥4 on the Numeric Rating Scale (NRS).
* Pain or tenderness on palpation over the thoracolumbar fascia region.
* Willingness to participate in the study.
* Provision of written informed consent.

\*\*Exclusion Criteria:\*\*

* Radiculopathy or significant neurological deficits.
* Neurogenic claudication due to spinal stenosis.
* Spinal tumor or infection.
* History or presence of vertebral fracture.
* Inflammatory rheumatic disease.
* Spinal surgery within the previous 6 months.
* Injection in the lumbar region within the previous 3 months.
* Anticoagulant therapy or conditions contraindicating injection.
* Active infection at the injection site.
* Severe systemic disease, including advanced renal failure.
* Uncontrolled diabetic metabolic condition.
* Pregnancy.

Where it's running

• Kanuni Sultan Suleyman Training and Research Hospital
  Küçükçekmece, Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Hatice Zehra FERHATLAR, MD
• Email: haticezehraferhatlar@gmail.com
• Phone: 05367387869

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.