Cervical Transforaminal Injection of Steroids Guided by Ultrasound

Shanghai Jiao Tong University Affiliated Sixth People's Hospital60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cervical Radiculopathy

Interventions

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)

CTF steroid (dexamethasone) injectionPROCEDURE

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)

DexamethasoneDRUG

One of the most efficient steroids

UltrasoundDEVICE

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

C armRADIATION

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 Outcomes

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

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

Data from ClinicalTrials.gov

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