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Cervical RadiculopathyNCT07275320

Cervical Retrolaminar Block Versus Cervical Epidural Injection for Cervical Radiculopathy

A study testing Fluoroscopy-guided cervical interlaminar epidural injection, Cervical Retrolaminar Block and Bupivacaine 0.25% in people with Cervical Radiculopathy, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cervical radiculopathy is a common clinical condition, affecting approximately 1 in 1,000 individuals each year, and is typically characterized by neck pain radiating to the upper extremities. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cervical Radiculopathy
What is being tested?
Fluoroscopy-guided cervical interlaminar epidural injection, Cervical Retrolaminar Block and Bupivacaine 0.25%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Dec 2024to 30 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a diagnosis of cervical radiculopathy confirmed by magnetic resonance imaging (MRI).
  • Visual Analog Scale (VAS) pain score ≥ 5 and an elevated Neck Disability Index (NDI) score.
  • Age between 18 and 80 years.
  • Patients without motor weakness or clinical signs of myelopathy.
  • Patients who did not respond to conservative treatments such as analgesics, physical therapy, or traction.

Who cannot join

  • Patients who do not provide informed consent or who have coagulopathy.
  • Patients with a known allergy to the study medications, organ failure, pregnancy, or lactation.
  • Patients with infection in the cervical spine or surrounding tissues, or those with rheumatologic, neurologic, or neuromuscular diseases.
  • Patients with a history of cervical spine surgery or with shoulder/peripheral nerve pathology that may confound the diagnosis.
  • Patients using neuropathic pain medications (such as pregabalin or gabapentin) or those with a cardiac pacemaker.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Goztepe Suleyman Yalcin City Hospital, Department of Anesthesiology and Reanimation, Interventional Pain Management Unit

    Istanbul, Kadikoy, Istanbul, 34722

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Effects of Ultrasound-Guided Cervical Retrolaminar Block and Fluoroscopy-Guided Cervical Epidural Injection in Cervical Radiculopathy

Cervical radiculopathy is a common clinical condition, affecting approximately 1 in 1,000 individuals each year, and is typically characterized by neck pain radiating to the upper extremities. Although about 90% of patients respond to conservative treatment, cervical epidural steroid injection is widely used as an interventional alternative to surgery in those with symptoms refractory to conservative management. However, concerns regarding the safety of cervical epidural steroid injection have increased in recent years. Ultrasound-guided cervical retrolaminar block, which does not require entry into the neuraxial space, is considered a theoretically safer technique.

In this prospective, randomized study, 70 patients with cervical radiculopathy refractory to conservative treatment were enrolled and randomly assigned to receive either ultrasound-guided cervical retrolaminar block (n = 35) or fluoroscopy-guided cervical epidural steroid injection (n = 35). The study aimed to compare the clinical efficacy and safety of these two interventional approaches.

Read the detailed description

Cervical radiculopathy is the fourth leading cause of disability in the United States. In the general population, the lifetime risk of developing neck pain is approximately 50%. Cervical radiculopathy is a common clinical condition, often presenting with neck pain radiating to the upper extremities, with an annual incidence of approximately 1.79 per 1,000 individuals. The natural course of cervical radiculopathy tends toward spontaneous recovery in more than 90% of patients. First-line treatment options are generally non-surgical and include analgesics, cervical stabilizing exercises, traction, and physical therapy. In patients requiring surgery, the most frequently applied procedures are decompression with or without fusion. However, cervical spine surgery carries important risks and complications. Reported complication rates include surgical site infection (0.7-4%), dysphagia in more than 20% of patients, nerve root injury in up to 12%, and spinal cord injury in approximately 0.01%. Cervical epidural steroid injection is one of the most widely used cervical interventions and provides a non-surgical alternative. In patients refractory to conservative treatment but without progressive neurological deficit, cervical epidural steroid injections are commonly recommended. Nevertheless, there is currently no consensus on the optimal technique that best balances safety and efficacy. In recent years, paraneuraxial interfascial blocks performed under ultrasound guidance have gained popularity due to their anatomical and clinical advantages. Cervical retrolaminar block belongs to this group. In this technique, the injectate is administered between the lamina of C6 or C7 and the multifidus muscle, where there are no critical vascular or neural structures; for example, the deep cervical artery courses more laterally. A more medial approach may also reduce the risk of phrenic nerve paresis. In contrast, cervical epidural injections are less localized and may be associated with systemic side effects such as hypotension, urinary retention, and motor impairment. Ultrasound-guided cervical retrolaminar block offers several potential advantages, including technical simplicity due to clear bony landmarks, a lower risk of vascular injury, a reduced likelihood of phrenic nerve involvement or systemic adverse effects, and avoidance of radiation exposure. The hypothesis of this study was that ultrasound-guided cervical retrolaminar block is non-inferior to fluoroscopy-guided cervical epidural steroid injection in terms of pain relief and functional improvement in patients with cervical radiculopathy refractory to conservative treatment, while potentially offering a safer alternative. This trial was conducted as a prospective, randomized, controlled study at Istanbul Medeniyet University, Faculty of Medicine, Goztepe Prof. Dr. Suleyman Yalcin City Hospital. Written informed consent was obtained from all participants prior to enrollment, and the study was performed in accordance with international ethical standards and the Declaration of Helsinki. A total of 70 patients were included. Eligible participants were between 18 and 80 years of age, had MRI-confirmed cervical radiculopathy with a clearly identified affected level, and presented with pain intensity of at least 5 on the Visual Analog Scale (VAS) and an elevated Neck Disability Index (NDI) score. Additional inclusion criteria were absence of motor weakness, absence of signs or symptoms of myelopathy, and refractoriness to conservative treatments including manipulation, traction, physical therapy, and oral analgesics. Exclusion criteria included refusal to provide consent; coagulopathy; allergy or intolerance to local anesthetics; severe organ failure; pregnancy or lactation; cervical spine or adjacent soft tissue infection; inflammatory rheumatologic disease; fibromyalgia; neurological or neuromuscular disorders; demyelinating diseases; polyneuropathy; congenital malformations; prior cervical spine surgery; and comorbidities such as carpal tunnel syndrome, cubital tunnel syndrome, thoracic outlet syndrome, brachial plexus injury, or shoulder pathology. Patients who had previously received local corticosteroid injections, those using neuropathic pain agents (e.g., pregabalin, gabapentin), and those with cardiac pacemakers were also excluded. Patients were randomized into two groups. Group 1 (n = 35) received interlaminar cervical epidural steroid injection under fluoroscopic guidance, and Group 2 (n = 35) underwent ultrasound-guided cervical retrolaminar block. Randomization was performed using a sealed-envelope method. Following group allocation, all patients were informed about the assigned procedure and signed a standardized written informed consent form that detailed the study objectives, duration, interventions, and potential risks. Patient assessments included baseline and post-procedural evaluations using the Visual Analog Scale and the Neck Disability Index. Measurements were recorded at baseline (VAS-0, NDI-0) and at weeks 1 (VAS-1, NDI-1), 4 (VAS-4, NDI-4), 8 (VAS-8, NDI-8), and 12 (VAS-12, NDI-12). Additional recorded variables included patient age, sex, side of block application, need for surgery during follow-up, and adverse effects or complications related to the procedures or local anesthetics.

Being tested
Fluoroscopy-guided cervical interlaminar epidural injection, Cervical Retrolaminar Block, Bupivacaine 0.25%, Dexamethasone
Keywords
Cervical retrolaminar block, Cervical epidural steroid injection, Cervical Radiculopathy
Medical subject headings
Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluoroscopy-guided cervical interlaminar epidural injectionProcedure or surgery

    A fluoroscopy-guided cervical interlaminar epidural injection was performed as a non-surgical treatment option for cervical radiculopathy. Under C-arm fluoroscopic guidance, the C7-T1 intervertebral space was identified. An 18-gauge Tuohy needle was advanced into the epidural space via a medial approach using the hanging drop technique. After confirming epidural spread with the injection of 1 mL of non-ionic contrast solution, an epidural injection was performed with a total of 8 mL of solution containing 0.25% bupivacaine and 8 mg dexamethasone.

  • Cervical Retrolaminar BlockProcedure or surgery

    patients who received a cervical retrolaminar block were administered a solution containing 0.25% bupivacaine and 8 mg dexamethasone under ultrasound guidance. The injectate was applied unilaterally with 4 mL or bilaterally with a total of 8 mL, depending on the patient's symptoms

  • Bupivacaine 0.25%Drug

    Bupivacaine 0.25% solution is used as the local anesthetic component of both the fluoroscopy-guided cervical interlaminar epidural injection and the ultrasound-guided cervical retrolaminar block.

  • DexamethasoneDrug

    Dexamethasone 8 mg is used as the corticosteroid component of both the fluoroscopy-guided cervical interlaminar epidural injection and the ultrasound-guided cervical retrolaminar block.

Study groups in NCT07275320
Study groupRoleWhat they receive
GRUP 1: Fluoroscopy-guided cervical interlaminar epidural InjectionActive comparatorParticipants in Group 1 are treated with a fluoroscopy-guided cervical interlaminar epidural injection consisting of 8 mL of a solution containing 0.25% bupivacaine and 8 mg dexamethasone.
Receives: Procedure: Fluoroscopy-guided cervical interlaminar epidural injection; Drug: Bupivacaine 0.25%; Drug: Dexamethasone
Group 2 - Ultrasound-guided cervical retrolaminar blockActive comparatorParticipants in Group 2 are treated with an ultrasound-guided cervical retrolaminar block using a solution containing 0.25% bupivacaine and 8 mg dexamethasone. The injectate is administered either unilaterally with 4 mL or bilaterally with a total of 8 mL, depending on the patient's symptoms.
Receives: Procedure: Cervical Retrolaminar Block; Drug: Bupivacaine 0.25%; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pain intensity assessed by the Visual Analog Scale (VAS)

    Pain intensity will be assessed in both groups using a 10-cm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst imaginable pain." VAS scores will be recorded before the procedure (baseline) and at 1, 4, 8, and 12 weeks after the intervention. The primary outcome is the change in VAS pain scores from baseline at 1, 4, 8, and 12 weeks and the comparison of these changes between the two treatment groups.

    Measured: At baseline and at 1, 4, 8, and 12 weeks after the procedure.

Secondary outcomes (2)
  1. Change in Neck Disability Index (NDI) score

    Functional disability will be evaluated using the Neck Disability Index (NDI). NDI scores will be recorded in both groups before the procedure (baseline) and at 1, 4, 8, and 12 weeks after the intervention. The secondary outcome is the change in NDI score from baseline at 1, 4, 8, and 12 weeks and the comparison of these changes between the two treatment groups.

    Measured: At baseline and at 1, 4, 8, and 12 weeks after the procedure.

  2. Incidence of treatment-related adverse events in both groups

    All procedure-related adverse events were recorded in both groups from the day of the procedure to 12 weeks after the intervention.

    Measured: Day of the procedure (baseline) to 12 weeks after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2025
  2. Study start5 Dec 2024
  3. Primary completion30 Mar 2025
  4. Study completion30 Jul 2025

Resources

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
This study was conducted using a parallel assignment design. A total of 70 patients with cervical radiculopathy unresponsive to conservative management were randomized in a 1:1 ratio to two groups using a sealed-envelope method. Group 1 was assigned to receive fluoroscopy-guided cervical epidural injection (ESI), and Group 2 was assigned to receive ultrasound-guided cervical retrolaminar block (CRLB). All participants were prospectively followed for 12 weeks.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07275320
Sponsor's protocol ID
CRLB-ANEST-NA-O1
Status last verified
Sep 2025
First submitted
17 Nov 2025
Last updated
11 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Fluoroscopy-guided cervical interlaminar epidural injection, Cervical Retrolaminar Block and Bupivacaine 0.25% in people with Cervical Radiculopathy, run by Istanbul Medeniyet University 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 11 Dec 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 pain intensity assessed by the Visual Analog Scale (VAS) (time frame: At baseline and at 1, 4, 8, and 12 weeks after the procedure.). 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 11 Dec 2025.

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