Ultrasound-Guided Thoracolumbar Fascia Injection for Chronic Low Back Pain in Patients With Type 2 Diabetes
Key facts
- Where
- Küçükçekmece, TürkiyeSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07927530, who can take part
Where in Türkiye
- Kanuni Sultan Suleyman Training and Research HospitalKüçükçekmece, TürkiyeTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hatice Zehra FERHATLAR
- Trial code
- NCT07927530
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
Efficacy of Ultrasound-Guided Thoracolumbar Fascia Injection in the Treatment of Chronic Low Back Pain in Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
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.
**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.