Lidocaine Hydrochloride 2% Injection Solution: 1 mL of lidocaine hydrochloride 20 mg/mL (2%) injection solution was administered as a component of the ultrasound-guided periradicular injection.
Dexamethasone 4 Mg/mL Injectable Solution: 2 mL of dexamethasone 4 mg/mL injection solution (total dose: 8 mg) was administered as a component of the ultrasound-guided periradicular injection.
Dextrose 5% Injection: 7 mL of 5% dextrose solution was administered as a component of the ultrasound-guided periradicular injection.
Sodium Chloride 0.9% Injection Solution: 7 mL of 0.9% sodium chloride solution was administered as a component of the ultrasound-guided periradicular injection.
Study summary
This study aims to compare the effects of different ultrasound-guided periradicular injection solutions in patients with chronic unilateral radicular pain caused by a single-level lumbar disc herniation.
Participants receive an ultrasound-guided periradicular injection containing lidocaine and dexamethasone, either alone or combined with 5% dextrose or 0.9% sodium chloride. The study evaluates whether adding dextrose or sodium chloride provides additional benefit in reducing pain and improving function and quality of life.
Pain intensity, disability, quality of life, and analgesic use are assessed before treatment and during follow-up. The main hypothesis is that the addition of 5% dextrose or 0.9% sodium chloride may improve the clinical effectiveness of the injection compared with lidocaine and dexamethasone alone.
Eligibility
Sex
ALL
Min age
25 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* Age between 25 and 65 years
* Persistent low back and leg pain despite conservative treatment
* Unilateral radicular pain accompanying chronic low back pain lasting longer than 3 months
* Single-level lumbar disc herniation (LDH) confirmed by clinical evaluation and magnetic resonance imaging (MRI)
* Low back pain and unilateral radicular leg pain with a Visual Analog Scale (VAS) score ≥4
* Provision of written informed consent to participate in the study
Exclusion Criteria:
* Lumbar epidural steroid injection within the previous 6 months or a history of major trauma
* History of allergy to any of the medications to be administered
* Body mass index (BMI) \>30 kg/m²
* Unstable chronic medical disease, such as diabetes mellitus, hypertension, or heart failure
* History of lumbar spine surgery
* History of coagulopathy
* History of malignancy
* History of polyneuropathy
* History of peripheral vascular disease
* Presence of a psychiatric disorder or cognitive impairment that would prevent completion of questionnaires and assessment scales, including dementia or significant visual or hearing impairment
* Local infection at the injection site or systemic infection
* Pregnancy and/or breastfeeding
* Neurological deficit in the lower extremities
* Unwillingness to participate in the study
Primary outcome measure(s)
Change in Leg Pain Intensity Assessed by Visual Analog Scale (VAS) — Baseline, 1 hour, 1 month, and 3 months after the intervention Leg pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. The change in VAS score from baseline will be evaluated at 1 hour, 1 month, and 3 months after the intervention.
Change in Low Back Pain Intensity Assessed by Visual Analog Scale (VAS) — Baseline, 1 hour, 1 month, and 3 months after the intervention Low back pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. The change in VAS score from baseline will be evaluated at 1 hour, 1 month, and 3 months after the intervention.
Trial sites (1)
Facility
City
Region
Status
Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
Ankara
Ankara
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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