Comparison of the Effectiveness of Ultrasound-Guided Periradicular Injections in Patients With Lumbar Radicular Pain

NCT07771374 | Active Not Recruiting

• 1 other identifier: E2-25-11164
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lumbar Disc Herniation With Radiculopathy

Keywords

Radiculopathy; Disc Herniation; Ultrasonographic Imaging; Dexamethasone; Spinal Injections

Outcome Measures

Primary Outcomes (2)

• Change in Leg Pain Intensity Assessed by Visual Analog Scale (VAS)

  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.

  Baseline, 1 hour, 1 month, and 3 months after the intervention

• Change in Low Back Pain Intensity Assessed by Visual Analog Scale (VAS)

  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.

  Baseline, 1 hour, 1 month, and 3 months after the intervention

Secondary Outcomes (3)

• Change in Disability Assessed by the Oswestry Disability Index (ODI)

  Baseline, 1 month, and 3 months after the intervention

• Change in Health-Related Quality of Life Assessed by the 36-Item Short Form Health Survey (SF-36)

  Baseline, 1 month, and 3 months after the intervention

• Change in Analgesic Medication Use

  Baseline, 1 month, and 3 months after the intervention

Study Arms (3)

Lidocaine + Dexamethasone

ACTIVE COMPARATOR

Participants receive a single ultrasound-guided periradicular injection containing 1 mL of 0.2% lidocaine hydrochloride and 8 mg/2 mL dexamethasone.

Drug: Lidocaine Hydrochloride 2% Injection Solution; Drug: Dexamethasone 4 Mg/mL Injectable Solution

Lidocaine + Dexamethasone + Dextrose

EXPERIMENTAL

Participants receive a single ultrasound-guided periradicular injection containing 1 mL of 0.2% lidocaine hydrochloride, 8 mg/2 mL dexamethasone, and 7 mL 5% dextrose.

Drug: Lidocaine Hydrochloride 2% Injection Solution; Drug: Dexamethasone 4 Mg/mL Injectable Solution; Drug: Dextrose 5% Injection

Lidocaine + Dexamethasone + Normal Saline

EXPERIMENTAL

Participants receive a single ultrasound-guided periradicular injection containing 1 mL of 0.2% lidocaine hydrochloride, 8 mg/2 mL dexamethasone, and 7 mL 0.9% sodium chloride.

Drug: Lidocaine Hydrochloride 2% Injection Solution; Drug: Dexamethasone 4 Mg/mL Injectable Solution; Drug: Sodium Chloride 0.9% Injection Solution

Interventions

Lidocaine Hydrochloride 2% Injection Solution DRUG

1 mL of lidocaine hydrochloride 20 mg/mL (2%) injection solution was administered as a component of the ultrasound-guided periradicular injection.

Also known as: Jetokain Simplex 20 mg/mL

Lidocaine + Dexamethasone; Lidocaine + Dexamethasone + Dextrose; Lidocaine + Dexamethasone + Normal Saline

Dexamethasone 4 Mg/mL Injectable Solution DRUG

2 mL of dexamethasone 4 mg/mL injection solution (total dose: 8 mg) was administered as a component of the ultrasound-guided periradicular injection.

Also known as: Dekort 8 mg/2 mL

Lidocaine + Dexamethasone; Lidocaine + Dexamethasone + Dextrose; Lidocaine + Dexamethasone + Normal Saline

Dextrose 5% Injection DRUG

7 mL of 5% dextrose solution was administered as a component of the ultrasound-guided periradicular injection.

Also known as: POLİFLEKS 5% Dextrose 100 mL

Lidocaine + Dexamethasone + Dextrose

Sodium Chloride 0.9% Injection Solution DRUG

7 mL of 0.9% sodium chloride solution was administered as a component of the ultrasound-guided periradicular injection.

Also known as: POLİFLEKS 0.9% Sodium Chloride 100 mL Solution for Infusion

Lidocaine + Dexamethasone + Normal Saline

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

Ankara, Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Radiculopathy; Intervertebral Disc Displacement

Interventions

Lidocaine; Dexamethasone; Glucose; Injections; Sodium Chloride; Solutions

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hexoses; Monosaccharides; Sugars; Carbohydrates; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were unaware of the assigned injection solution.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Resident Physician

Model Details: Three parallel groups receive different ultrasound-guided periradicular injection solutions and are followed for 3 months.

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 18, 2026
• Study Start: May 21, 2025
• Primary Completion: September 9, 2026
• Study Completion: September 9, 2026
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)