Lumbar Disc Herniation With RadiculopathyNCT07771374
Comparison of the Effectiveness of Ultrasound-Guided Periradicular Injections in Patients With Lumbar Radicular Pain
A study testing Lidocaine Hydrochloride 2% Injection Solution, Dexamethasone 4 Mg/mL Injectable Solution and Dextrose 5% Injection in people with Lumbar Disc Herniation With Radiculopathy, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Lumbar Disc Herniation With Radiculopathy
- What is being tested?
- Lidocaine Hydrochloride 2% Injection Solution, Dexamethasone 4 Mg/mL Injectable Solution and Dextrose 5% Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 May 2025to 9 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
Ankara, Ankara, 06800
About this study
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.
Read the detailed description
The aim of this study is to evaluate whether the addition of 5% dextrose or 0.9% sodium chloride to a corticosteroid and local anesthetic solution provides additional benefit in patients with unilateral radicular pain due to single-level lumbar disc herniation. The study also evaluates whether these solutions may facilitate separation of the disc material and surrounding soft tissues from the affected nerve root and whether dextrose provides an additional analgesic effect in relieving radicular pain.
The study was designed as a randomized, controlled, prospective, single-blind clinical trial. A total of 33 patients aged 25-65 years with chronic low back pain resistant to conservative treatment and unilateral radicular leg pain, with single-level lumbar disc herniation confirmed by physical examination and magnetic resonance imaging, were included.
Participants were assigned to treatment groups according to a computer-generated randomization scheme. With n = 11 participants in each group, the first group received a total of 3 mL consisting of 1 mL of 0.2% lidocaine hydrochloride and 8 mg/2 mL of dexamethasone. The second group received a total of 10 mL consisting of 1 mL of 0.2% lidocaine hydrochloride, 8 mg/2 mL of dexamethasone, and 7 mL of 5% dextrose. The third group received a total of 10 mL consisting of 1 mL of 0.2% lidocaine hydrochloride, 8 mg/2 mL of dexamethasone, and 7 mL of 0.9% sodium chloride solution.
Participants were unaware of their assigned treatment group. In all participants, injections were administered under sterile conditions in the outpatient interventional procedure room with the participant in the prone position. All procedures were performed under ultrasound guidance using a 1-5 MHz convex probe as a single-session, unilateral, single-level periradicular injection.
Participants were evaluated at four time points: before the injection, 1 hour after the injection, and during face-to-face follow-up visits at 1 and 3 months. The primary outcome measure was pain intensity assessed using the Visual Analog Scale (VAS). Secondary outcome measures included the Oswestry Disability Index (ODI), the Short Form-36, and the amount of analgesic use.
- Being tested
- Lidocaine Hydrochloride 2% Injection Solution, Dexamethasone 4 Mg/mL Injectable Solution, Dextrose 5% Injection, Sodium Chloride 0.9% Injection Solution
- Keywords
- Radiculopathy, Disc Herniation, Ultrasonographic Imaging, Dexamethasone, Spinal Injections
- Medical subject headings
- Radiculopathy, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine Hydrochloride 2% Injection SolutionDrug
Also called Jetokain Simplex 20 mg/mL
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 SolutionDrug
Also called Dekort 8 mg/2 mL
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% InjectionDrug
Also called POLİFLEKS 5% Dextrose 100 mL
7 mL of 5% dextrose solution was administered as a component of the ultrasound-guided periradicular injection.
Sodium Chloride 0.9% Injection SolutionDrug
Also called POLİFLEKS 0.9% Sodium Chloride 100 mL Solution for Infusion
7 mL of 0.9% sodium chloride solution was administered as a component of the ultrasound-guided periradicular injection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Lidocaine Hydrochloride 2% Injection Solution; Drug: Dexamethasone 4 Mg/mL Injectable Solution; Drug: Sodium Chloride 0.9% Injection Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 1 hour, 1 month, and 3 months after the intervention
Secondary outcomes (3)
Change in Disability Assessed by the Oswestry Disability Index (ODI)
Disability related to low back pain will be assessed using the Oswestry Disability Index (ODI). The ODI consists of 10 sections, each scored from 0 to 5, with a total raw score ranging from 0 to 50. The total score is converted to a percentage, ranging from 0% to 100%, where higher scores indicate greater disability. The change in ODI score from baseline will be evaluated during follow-up.
Measured: 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)
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The questionnaire evaluates eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better health-related quality of life. Changes in SF-36 domain scores from baseline will be evaluated during follow-up.
Measured: Baseline, 1 month, and 3 months after the intervention
Change in Analgesic Medication Use
Analgesic medication use during the previous month will be recorded as the number of days of analgesic use multiplied by the number of analgesic doses taken per day (days × doses). Changes in analgesic medication use from baseline will be evaluated during follow-up.
Measured: Baseline, 1 month, and 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start21 May 2025
- Primary completion9 Sep 2026 (estimated)
- Study completion9 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc Herniation With RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three parallel groups receive different ultrasound-guided periradicular injection solutions and are followed for 3 months.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Yunusozkan, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771374
- Sponsor's protocol ID
- E2-25-11164
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to participant confidentiality and data protection considerations.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Ultrasound-Guided Periradicular Injections in Patients With Lumbar Radicular Pain
- ClinicalTrials.gov ID
- NCT07771374
- Acronym / sponsor ID
- E2-25-11164
- Keywords
- Radiculopathy, Disc Herniation, Ultrasonographic Imaging, Dexamethasone, Spinal Injections
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- 9 Sep 2026 (estimated)
- Study completion
- 9 Sep 2026 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this study is to evaluate whether the addition of 5% dextrose or 0.9% sodium chloride to a corticosteroid and local anesthetic solution provides additional benefit in patients with unilateral radicular pain due to single-level lumbar disc herniation. The study also evaluates whether these solutions may facilitate separation of the disc material and surrounding soft tissues from the affected nerve root and whether dextrose provides an additional analgesic effect in relieving radicular pain.
The study was designed as a randomized, controlled, prospective, single-blind clinical trial. A total of 33 patients aged 25-65 years with chronic low back pain resistant to conservative treatment and unilateral radicular leg pain, with single-level lumbar disc herniation confirmed by physical examination and magnetic resonance imaging, were included.
Participants were assigned to treatment groups according to a computer-generated randomization scheme. With n = 11 participants in each group, the first group received a total of 3 mL consisting of 1 mL of 0.2% lidocaine hydrochloride and 8 mg/2 mL of dexamethasone. The second group received a total of 10 mL consisting of 1 mL of 0.2% lidocaine hydrochloride, 8 mg/2 mL of dexamethasone, and 7 mL of 5% dextrose. The third group received a total of 10 mL consisting of 1 mL of 0.2% lidocaine hydrochloride, 8 mg/2 mL of dexamethasone, and 7 mL of 0.9% sodium chloride solution.
Participants were unaware of their assigned treatment group. In all participants, injections were administered under sterile conditions in the outpatient interventional procedure room with the participant in the prone position. All procedures were performed under ultrasound guidance using a 1-5 MHz convex probe as a single-session, unilateral, single-level periradicular injection.
Participants were evaluated at four time points: before the injection, 1 hour after the injection, and during face-to-face follow-up visits at 1 and 3 months. The primary outcome measure was pain intensity assessed using the Visual Analog Scale (VAS). Secondary outcome measures included the Oswestry Disability Index (ODI), the Short Form-36, and the amount of analgesic use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Three parallel groups receive different ultrasound-guided periradicular injection solutions and are followed for 3 months.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine + Dexamethasone | Active comparator | Drug: Lidocaine Hydrochloride 2% Injection Solution, Drug: Dexamethasone 4 Mg/mL Injectable SolutionParticipants receive a single ultrasound-guided periradicular injection containing 1 mL of 0.2% lidocaine hydrochloride and 8 mg/2 mL dexamethasone. |
| Lidocaine + Dexamethasone + Dextrose | Experimental | Drug: Lidocaine Hydrochloride 2% Injection Solution, Drug: Dexamethasone 4 Mg/mL Injectable Solution, Drug: Dextrose 5% InjectionParticipants 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. |
| Lidocaine + Dexamethasone + Normal Saline | Experimental | Drug: Lidocaine Hydrochloride 2% Injection Solution, Drug: Dexamethasone 4 Mg/mL Injectable Solution, Drug: Sodium Chloride 0.9% Injection SolutionParticipants 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine Hydrochloride 2% Injection SolutionAlso: Jetokain Simplex 20 mg/mL1 mL of lidocaine hydrochloride 20 mg/mL (2%) injection solution was administered as a component of the ultrasound-guided periradicular injection. | Drug | Lidocaine + Dexamethasone, Lidocaine + Dexamethasone + Dextrose, Lidocaine + Dexamethasone + Normal Saline |
| Dexamethasone 4 Mg/mL Injectable SolutionAlso: Dekort 8 mg/2 mL2 mL of dexamethasone 4 mg/mL injection solution (total dose: 8 mg) was administered as a component of the ultrasound-guided periradicular injection. | Drug | Lidocaine + Dexamethasone, Lidocaine + Dexamethasone + Dextrose, Lidocaine + Dexamethasone + Normal Saline |
| Dextrose 5% InjectionAlso: POLİFLEKS 5% Dextrose 100 mL7 mL of 5% dextrose solution was administered as a component of the ultrasound-guided periradicular injection. | Drug | Lidocaine + Dexamethasone + Dextrose |
| Sodium Chloride 0.9% Injection SolutionAlso: POLİFLEKS 0.9% Sodium Chloride 100 mL Solution for Infusion7 mL of 0.9% sodium chloride solution was administered as a component of the ultrasound-guided periradicular injection. | Drug | Lidocaine + Dexamethasone + Normal Saline |
Primary outcome
Change in Leg Pain Intensity Assessed by Visual Analog Scale (VAS)
Time frame: 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)
Time frame: 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.
3 secondary outcomes
Change in Disability Assessed by the Oswestry Disability Index (ODI)
Time frame: 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)
Time frame: Baseline, 1 month, and 3 months after the intervention
Change in Analgesic Medication Use
Time frame: Baseline, 1 month, and 3 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to participant confidentiality and data protection considerations.
Related trials for Lumbar Disc Herniation With Radiculopathy
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Not yet recruiting
Randomized Evaluation of Lumbar Injection Effectiveness and Function
Lumbar Radiculopathy, Lumbar Disc Herniation
Recruiting
Acute Effects of Neurodynamics on Strength and Endurance in Athletes
Sciatic Leg Pain, Hamstring Muscle Tightness
Recruiting
High-Intensity Laser Therapy Versus Transforaminal Epidural Steroid Injection in Chronic Lumbar Disc Herniation-Related Low Back and Radicular Pain
Lumbar Disc Herniation, Chronic Low Back Pain
Recruiting
FINDISC-Pain, Finnish Discectomy Trial on the Benefits and Harms of Surgery in Patients With Lumbar Disc Herniation
Lumbar Disc Herniation With Radiculopathy, Sciatica
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine Hydrochloride 2% Injection Solution, Dexamethasone 4 Mg/mL Injectable Solution and Dextrose 5% Injection in people with Lumbar Disc Herniation With Radiculopathy, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Leg Pain Intensity Assessed by Visual Analog Scale (VAS) (time frame: Baseline, 1 hour, 1 month, and 3 months after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.