Cervical Transforaminal Injection of Steroids Guided by Ultrasound

November 19, 2014 updated by: Dongping Du, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: USNR steroid injection
the patient who are treated with steroid (dexamethasone) injection through selected cervical spinal nerve block approach guided by ultrasound and C arm.
Procedure: SNR steroid (dexamethasone) injection

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)

Drug: Dexamethasone
One of the most efficient steroids
Other Names:
  • DXM
Device: Ultrasound
Ultrasound (S-Nerve; SonoSite, Bothell, Wash), Probe 9L (6 MHz, SonoSite, Bothell, Wash)
Radiation: C arm
the needle position will be re-confirmed by C arm C arm (Philips Healthcare, Best, the Netherlands）
Experimental: UCTF steroid injection
the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided by ultrasound and C arm.
Drug: Dexamethasone
One of the most efficient steroids
Other Names:
  • DXM
Device: Ultrasound
Ultrasound (S-Nerve; SonoSite, Bothell, Wash), Probe 9L (6 MHz, SonoSite, Bothell, Wash)
Radiation: C arm
the needle position will be re-confirmed by C arm C arm (Philips Healthcare, Best, the Netherlands）
Procedure: CTF steroid (dexamethasone) injection

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)
Experimental: XCTF steroid injection
the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided only by C arm.
Drug: Dexamethasone
One of the most efficient steroids
Other Names:
  • DXM
Radiation: C arm
the needle position will be re-confirmed by C arm C arm (Philips Healthcare, Best, the Netherlands）
Procedure: CTF steroid (dexamethasone) injection

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 day before, 1day after, 1week after and 4 weeks after the intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 day before, 1day after, 1week after and 4 weeks after the intervention
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
1 day before, 1day after, 1week after and 4 weeks after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

November 16, 2014

First Submitted That Met QC Criteria

November 18, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Estimate)

November 21, 2014

Last Update Submitted That Met QC Criteria

November 19, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-46

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervical Radiculopathy

Clinical Trials on SNR steroid (dexamethasone) injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe