Cervical Transforaminal Injection of Steroids Guided by Ultrasound

Shanghai Jiao Tong University

Status

Unknown

Conditions

Cervical Radiculopathy

Treatments

Procedure: CTF steroid (dexamethasone) injection

Device: Ultrasound

Drug: Dexamethasone

Procedure: SNR steroid (dexamethasone) injection

Radiation: C arm

Study type

Interventional

Funder types

Other

Identifiers

NCT02295709

2014-46

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 3 patient groups

USNR steroid injection

Experimental group

Description:

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

Treatment:

Device: Ultrasound

Drug: Dexamethasone

Procedure: SNR steroid (dexamethasone) injection

Radiation: C arm

UCTF steroid injection

Experimental group

Description:

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

Treatment:

Device: Ultrasound

Drug: Dexamethasone