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Cervical Transforaminal Injection of Steroids Guided by Ultrasound

NCT ID: NCT02295709

Last Updated: 2014-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Radiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

SNR steroid (dexamethasone) injection

Intervention Type PROCEDURE

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)

Dexamethasone

Intervention Type DRUG

One of the most efficient steroids

Ultrasound

Intervention Type DEVICE

Ultrasound (S-Nerve; SonoSite, Bothell, Wash), Probe 9L (6 MHz, SonoSite, Bothell, Wash)

C arm

Intervention Type RADIATION

the needle position will be re-confirmed by C arm C arm (Philips Healthcare, Best, the Netherlands）

UCTF steroid injection

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

Group Type EXPERIMENTAL

CTF steroid (dexamethasone) injection

Intervention Type PROCEDURE

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)

Dexamethasone

Intervention Type DRUG

One of the most efficient steroids

Ultrasound

Intervention Type DEVICE

Ultrasound (S-Nerve; SonoSite, Bothell, Wash), Probe 9L (6 MHz, SonoSite, Bothell, Wash)

C arm

Intervention Type RADIATION

the needle position will be re-confirmed by C arm C arm (Philips Healthcare, Best, the Netherlands）

XCTF steroid injection

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

Group Type EXPERIMENTAL

CTF steroid (dexamethasone) injection

Intervention Type PROCEDURE

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)

Dexamethasone

Intervention Type DRUG

One of the most efficient steroids

C arm

Intervention Type RADIATION

the needle position will be re-confirmed by C arm C arm (Philips Healthcare, Best, the Netherlands）

Interventions

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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)

Intervention Type 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)

Intervention Type PROCEDURE

Dexamethasone

One of the most efficient steroids

Intervention Type DRUG

Ultrasound

Ultrasound (S-Nerve; SonoSite, Bothell, Wash), Probe 9L (6 MHz, SonoSite, Bothell, Wash)

Intervention Type DEVICE

C arm

the needle position will be re-confirmed by C arm C arm (Philips Healthcare, Best, the Netherlands）

Intervention Type RADIATION

Other Intervention Names

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DXM

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dongping Du

Pain Management Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2014-46

Identifier Type: -

Identifier Source: org_study_id