ClinicalTrials.gg
CompletedNCT07771374Updated Nov 3, 2026

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

An interventional study of Lidocaine Hydrochloride 2% Injection Solution and Dexamethasone 4 Mg/mL Injectable Solution in Lumbar Disc Herniation With Radiculopathy, sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jul 2025, registered Aug 2026).
Updated Nov 3, 2026Now CompletedStart date movedGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 59 studies in Radiculopathy with a site in Turkey — 16 open to participants now, 19 under way, none of them phase 3. Radiculopathy · Turkey.

Enrollment
31st of 33
33 · median 60
Started
2025
with 11 others
No phase
30 of 59
7 open now
Registered
53rd of 59
by date
Lead sponsor
2 of 59
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Among the 59 studies in Radiculopathy with a site in Turkey, this one is the 31st largest by enrollment of the 33 interventional ones that give a count, is one of 12 that started in 2025, is one of 30 with no phase, and was the 53rd registered.

Radiculopathy

484 studies on the registry are indexed under Radiculopathy; 144 are open to participants now.

Browse Radiculopathy studies →

Open to participants now

16 of the 59 studies in Radiculopathy with a site in Turkey are open now. Recruiting first, the newest first:

11 more — sign in →

All 16 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 79 Radiculopathy studies recruiting now, 23 (29%) set no upper age limit and 48 (61%) stop at 75 or younger; 3 take children under 18; 7 take healthy volunteers.

This study: 25 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

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.

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.

03

Conditions studied

  • Lumbar Disc Herniation With Radiculopathy

Keywords

  • Radiculopathy
  • Disc Herniation
  • Ultrasonographic Imaging
  • Dexamethasone
  • Spinal Injections
04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Lumbar epidural injection within the previous 6 months or a history of major trauma
  • History of allergy to any of the medications to be administered
  • (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
  • 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
33 participants (actual)

Study arms

  • Active comparator
    Lidocaine + Dexamethasone

    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

  • Experimental
    Lidocaine + Dexamethasone + Dextrose

    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

  • Experimental
    Lidocaine + Dexamethasone + Normal Saline

    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

  • 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

  • DrugDexamethasone 4 Mg/mL Injectable Solution

    Drug page: Dexamethasone

    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

  • 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

  • 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 1 hour, 1 month, and 3 months after the intervention

  2. 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.

    Time frame: Baseline, 1 hour, 1 month, and 3 months after the intervention

Secondary outcomes

  1. 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.

    Time frame: Baseline, 1 month, and 3 months after the intervention

  2. 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.

    Time frame: Baseline, 1 month, and 3 months after the intervention

  3. 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.

    Time frame: Baseline, 1 month, and 3 months after the intervention

07

Study locations

1 site
  • Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
    Ankara, Ankara 06800, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared due to participant confidentiality and data protection considerations.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2025 to primary completion in Sep 2026, 13 months.

Of 204 non-industry interventional studies with no phase under Radiculopathy, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's 13 months is above that.

Counting every sponsor, half of 216 studies reached it within 12 months; a quarter within 5 and three quarters within 45.

Start moved once since we started tracking on Sep 25, 2026: May 2025 → Jul 2025, on Nov 3, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2026
First posted
Aug 18, 2026
StartActual
Jul 21, 2025was May 2025
Primary completionActual
Sep 9, 2026
CompletionActual
Sep 9, 2026
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Active, not recruiting→Completed
changed Nov 3, 2026
Start date
May 21, 2025→Jul 21, 2025
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Active, not recruiting→Completed
    Start date May 21, 2025→Jul 21, 2025
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07771374
Lead sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Responsible party
Zeynep Yunusozkan (Physical Medicine and Rehabilitation Resident Physician, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital) — Principal investigator
First posted
Aug 18, 2026
Start date
Jul 21, 2025
Primary completion
Sep 9, 2026
Completion
Sep 9, 2026
Last update
Nov 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Glucose · Sodium Chloride

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