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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Not applicable

Age range

18 years - 65 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

60 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

\*\*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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Single masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Hatice Zehra FERHATLAR

Study start

Oct 23, 2026 Actual

Primary completion

Apr 30, 2027 Estimated

Study completion

Apr 30, 2027 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts