search
Back to results

Cervical Transforaminal Injection of Steroids Guided by Ultrasound

Primary Purpose

Cervical Radiculopathy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SNR steroid (dexamethasone) injection
CTF steroid (dexamethasone) injection
Dexamethasone
Ultrasound
C arm
Sponsored by
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy focused on measuring ultrasound, cervical Transformational Epidural Steroid Injection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • evidence of a cervical radiculopathy involving 1 spinal nerve of at least 1 month's duration refractory to medical treatment
  • symptoms of cervical pain radiating to the upper limb
  • and signs of altered sensations, ab- normal reflexes, or motor weakness caused by degenerative spondylosis and/or disk herniation as documented at CT or MR imaging and a current mean pain VAS score of six.

Exclusion criteria:

  • evidence of vertebral fracture, tumor, or infection of the cervical spine
  • treatment with cervical corticosteroid injections within the past 3 months
  • coagulopathy
  • allergy to iodinated contrast media.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    USNR steroid injection

    UCTF steroid injection

    XCTF steroid injection

    Arm Description

    the patient who are treated with steroid (dexamethasone) injection through selected cervical spinal nerve block approach guided by ultrasound and C arm.

    the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided by ultrasound and C arm.

    the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided only by C arm.

    Outcomes

    Primary Outcome Measures

    change of pain severity rated on a Visual Analog Scale (VAS)

    Secondary Outcome Measures

    change of neck actives rated on Neck Disability Index (NDI)
    change of medication use rated on Medication Quantitative Scale (MQS)

    Full Information

    First Posted
    November 16, 2014
    Last Updated
    November 19, 2014
    Sponsor
    Shanghai Jiao Tong University Affiliated Sixth People's Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02295709
    Brief Title
    Cervical Transforaminal Injection of Steroids Guided by Ultrasound
    Official Title
    Cervical Transforaminal Injection of Steroids Guided by Ultrasound
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    January 2015 (Anticipated)
    Study Completion Date
    March 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Jiao Tong University Affiliated Sixth People's Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Cervical transforaminal epidural steroid injections (TFESI) are indicated in cervical radicular pain resistant to conservation therapy, by which steroids can be delivered into anterior epidural space surrounding target spinal nerve roots to help alleviate pain in the upper limb or neck. Cervical TFESI is traditionally commended to perform with guidance of fluoroscopy or CT. As fluoroscopy can not monitor the injection route whether it pass vessel or not, many serious neurological complications caused by inadvertent intra-arterial injection have been reported2. Here, the investigators will introduce a novel cervical TFESI guided by ultrasound, which incidence of inadvertent vessel injury or injection might be lower than those guided by fluoroscopy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Radiculopathy
    Keywords
    ultrasound, cervical Transformational Epidural Steroid Injection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    USNR steroid injection
    Arm Type
    Experimental
    Arm Description
    the patient who are treated with steroid (dexamethasone) injection through selected cervical spinal nerve block approach guided by ultrasound and C arm.
    Arm Title
    UCTF steroid injection
    Arm Type
    Experimental
    Arm Description
    the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided by ultrasound and C arm.
    Arm Title
    XCTF steroid injection
    Arm Type
    Experimental
    Arm Description
    the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided only by C arm.
    Intervention Type
    Procedure
    Intervention Name(s)
    SNR steroid (dexamethasone) injection
    Intervention Description
    deliver steroids (dexamethasone) into spinal nerve root with the guidance of ultrasound. Device: Ultrasound (S-Nerve; SonoSite, Bothell, Wash), Probe 9L (6 MHz, SonoSite, Bothell, Wash)
    Intervention Type
    Procedure
    Intervention Name(s)
    CTF steroid (dexamethasone) injection
    Intervention Description
    deliver steroids (dexamethasone) into spinal epidural space with the guidance of ultrasound. Device: Ultrasound (S-Nerve; SonoSite, Bothell, Wash), Probe 9L (6 MHz, SonoSite, Bothell, Wash)
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Other Intervention Name(s)
    DXM
    Intervention Description
    One of the most efficient steroids
    Intervention Type
    Device
    Intervention Name(s)
    Ultrasound
    Intervention Description
    Ultrasound (S-Nerve; SonoSite, Bothell, Wash), Probe 9L (6 MHz, SonoSite, Bothell, Wash)
    Intervention Type
    Radiation
    Intervention Name(s)
    C arm
    Intervention Description
    the needle position will be re-confirmed by C arm C arm (Philips Healthcare, Best, the Netherlands）
    Primary Outcome Measure Information:
    Title
    change of pain severity rated on a Visual Analog Scale (VAS)
    Time Frame
    1 day before, 1day after, 1week after and 4 weeks after the intervention
    Secondary Outcome Measure Information:
    Title
    change of neck actives rated on Neck Disability Index (NDI)
    Time Frame
    1 day before, 1day after, 1week after and 4 weeks after the intervention
    Title
    change of medication use rated on Medication Quantitative Scale (MQS)
    Time Frame
    1 day before, 1day after, 1week after and 4 weeks after the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: evidence of a cervical radiculopathy involving 1 spinal nerve of at least 1 month's duration refractory to medical treatment symptoms of cervical pain radiating to the upper limb and signs of altered sensations, ab- normal reflexes, or motor weakness caused by degenerative spondylosis and/or disk herniation as documented at CT or MR imaging and a current mean pain VAS score of six. Exclusion criteria: evidence of vertebral fracture, tumor, or infection of the cervical spine treatment with cervical corticosteroid injections within the past 3 months coagulopathy allergy to iodinated contrast media.

    12. IPD Sharing Statement

    Learn more about this trial

    Cervical Transforaminal Injection of Steroids Guided by Ultrasound

    We'll reach out to this number within 24 hrs