NCT05340179

Brief Summary

Cervical epidural steroid injections are an accepted treatment modality for radicular pain secondary to disc pathology. With the developing ultrasound technology, ultrasound guided cervical selective nerve root block has been successfully used in the treatment of cervical radiculopathy. We aimed to compare the efficacy of cervical interlaminar epidural injections and cervical selective nerve root block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

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

First Submitted

Initial submission to the registry

April 14, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

11 months

First QC Date

April 14, 2022

Last Update Submit

May 1, 2023

Conditions

Cervical Radiculopathy

Outcome Measures

Primary Outcomes (1)

  • Reduction in pain

    Pain assessment will be performed using the Numerical Rating Scale (NRS) score (0 = no pain, 10 = the most severe pain felt).

    Change from baseline pain score to 6months

Secondary Outcomes (1)

  • Neck Disability Index

    baseline to 6 months post-procedure

Study Arms (2)

Interlaminar cervical epidural steroid injection

ACTIVE COMPARATOR
Procedure: Interlaminar cervical epidural injection

Cervical selective nerve root block

EXPERIMENTAL
Procedure: Cervical selective nerve root block

Interventions

Interlaminar cervical epidural injectionPROCEDURE

Fluoroscopy-guided interlaminar cervical epidural injection

Interlaminar cervical epidural steroid injection
Cervical selective nerve root blockPROCEDURE

Ultrasound-guided cervical selective nerve root block

Cervical selective nerve root block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cervical radicular pain based on history and physical exam
  • NRS pain score \> 3

You may not qualify if:

  • Previous spine surgery
  • Allergic reactions to drugs used in procedure
  • Epidural steroid injection within past 2 years
  • Radiculopathy not resulting from disc pathology (e.g. foraminal stenosis or tumor)
  • Untreated coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Yildirim Beyazit Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • selin guven kose

    Diskapi Yildirim Beyazit Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal Investigator

Study Record Dates

First Submitted

April 14, 2022

First Posted

April 22, 2022

Study Start

April 25, 2022

Primary Completion

April 1, 2023

Study Completion

April 30, 2023

Last Updated

May 3, 2023

Record last verified: 2023-05

Locations

TU(1)