NCT07476235

Brief Summary

Purpose: Stellate ganglion block (SGB) is a procedure that uses ultrasound to guide a needle near a group of nerves in the neck called the stellate ganglion. A local anesthetic is then injected to block pain signals. This procedure has recently shown promise as a treatment for cervical radicular pain - pain that travels from the neck down into the arm, usually caused by a pinched nerve in the spine. While SGB appears to be effective for many patients, not all patients respond equally well. Currently, there is no way to predict before the procedure which patients are likely to benefit and which are not. Identifying such predictors would help doctors select the right patients for this treatment and avoid unnecessary procedures. Study Question: This study aimed to determine whether specific clinical characteristics or imaging findings on MRI could predict whether a patient would have a successful pain response after receiving SGB for cervical radicular pain. Methods: This was a retrospective study that reviewed the medical records of patients who received ultrasound-guided SGB at a single medical center between October 2018 and April 2023. Patients were included if they had one-sided arm pain caused by a pinched nerve confirmed on MRI and had not improved after at least one month of standard treatments such as medication and physical therapy. Information collected from medical records included patient age, sex, body mass index, presence of diabetes or hypertension, pain severity (measured on a 0-to-10 scale), duration of symptoms, and neck disability scores. Imaging findings from cervical MRI were also evaluated, including the degree of nerve compression, the cause of the compression (soft disc herniation versus bony overgrowth), the condition of the spinal canal, disc degeneration, and the amount of fatty changes in the small muscles along the back of the neck (called the multifidus muscles). Hypothesis: The study hypothesized that certain imaging-based factors - specifically, significant fatty degeneration of the cervical multifidus muscles and bony overgrowth as the main cause of nerve compression - would be associated with a poorer response to SGB at 3 months after the procedure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

March 12, 2026

Last Update Submit

March 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Successful response

    Successful response was defined as either a reduction of ≥4 points on the numerical rating scale or a ≥50% decrease in pain intensity at 3 months post-procedure.

    At 3 months post-procedure

Study Arms (2)

Successful responder

Successful responders were defined as patients who demonstrated either a reduction of ≥4 points on the numerical rating scale or a ≥50% decrease in pain at 3 months post-procedure.

Other: Cervical multifidus fatty degenerationOther: Primary etiology of foraminal stenosisDrug: Steroid use during stellate ganglion blockOther: Other collected data

Unsuccessful responder

Patients who did not achieve a successful response or who underwent additional interventional procedures within 3 months were classified as unsuccessful responders.

Other: Cervical multifidus fatty degenerationOther: Primary etiology of foraminal stenosisDrug: Steroid use during stellate ganglion blockOther: Other collected data

Interventions

Cervical multifidus fatty degeneration was assessed by evaluating the degree of fatty infiltration in the bilateral multifidus muscles at the C5-C6 level, which is a region noted for its high mechanical load and flexibility, rendering it susceptible to degenerative changes.T2-weighted axial MRI images were analyzed, and fatty infiltration of the cervical multifidus muscle was graded using the Goutallier classification as follows: grade 0 (no fat signal), grade 1 (minimal fat signal), grade 2 (more muscle than fat), grade 3 (equal amounts of fat and muscle), and grade 4 (more fat than muscle) (Fig. 1). For the analysis, cervical multifidus fatty degeneration was defined as minimal (Goutallier grades 0-1) or substantial (Goutallier grades 2-4).

Successful responderUnsuccessful responder

The primary etiology of foraminal stenosis was determined by differentiating between disc herniation and bony hypertrophy at the uncovertebral or facet joint, based on the more prominent lesion.

Successful responderUnsuccessful responder

Use of dexamethasone 5 mg added to 6 mL of 1% lidocaine versus 1% lidocaine alone during ultrasound-guided stellate ganglion block, based on the treating physician's clinical decision.

Successful responderUnsuccessful responder

Other collected data included patient demographics, such as age, sex, body mass index, and comorbidities, including diabetes and hypertension, pre-procedural symptoms such as radicular pain with or without neck pain, neck disability index, pain duration, cervical curvature types, central stenosis grade, foraminal stenosis grade, and disc degeneration.

Successful responderUnsuccessful responder

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 19 years or older with unilateral cervical radicular pain who underwent ultrasound-guided stellate ganglion block at the pain clinic of Asan Medical Center, Seoul, Korea, between October 2018 and April 2023. All patients had MRI-confirmed cervical foraminal stenosis consistent with their symptoms and had failed at least 1 month of conservative treatment including medication and physical therapy. Patients were excluded if they had a history of cervical spine surgery, bilateral or multi-segment involvement, neck pain exceeding arm pain, other contributing pain conditions, or insufficient medical records.

You may qualify if:

  • Unilateral cervical radicular pain
  • Evidence of cervical foraminal stenosis on magnetic resonance imaging (MRI) consistent with radicular pain
  • Age ≥ 19 years
  • Symptoms unresponsive to at least 1 month of conservative treatment, including medication and physical therapy

You may not qualify if:

  • History of cervical spine surgery
  • Bilateral symptoms or involvement of three or more segments
  • Neck pain intensity greater than arm-pain intensity
  • Other conditions, such as facet joint syndrome or myofascial pain syndrome, contributing to the symptoms
  • Insufficient documentation in the electronic medical records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 17, 2026

Study Start

October 8, 2024

Primary Completion

September 15, 2025

Study Completion

September 15, 2025

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations