Cervical Transforaminal Injection of Steroids Guided by Ultrasound

Not Applicable

• Conditions: Cervical Radiculopathy
• Interventions: Procedure: SNR steroid (dexamethasone) injection; Procedure: CTF steroid (dexamethasone) injection; Drug: Dexamethasone; Device: Ultrasound; Radiation: C arm

• Registration Number: NCT02295709
• Lead Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Status Verified: 2014-11
• Study First Submitted: 2014-11-16
• Study First Submitted QC: 2014-11-18
• Last Update Submitted: 2014-11-19
• Study First Posted: 2014-11-20
• Last Update Posted: 2014-11-21
• Primary Completion: 2015-01
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
USNR steroid injection	SNR steroid (dexamethasone) injection	the patient who are treated with steroid (dexamethasone) injection through selected cervical spinal nerve block approach guided by ultrasound and C arm.
UCTF steroid injection	Ultrasound	the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided by ultrasound and C arm.
USNR steroid injection	C arm	the patient who are treated with steroid (dexamethasone) injection through selected cervical spinal nerve block approach guided by ultrasound and C arm.
UCTF steroid injection	CTF steroid (dexamethasone) injection	the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided by ultrasound and C arm.
XCTF steroid injection	CTF steroid (dexamethasone) injection	the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided only by C arm.
USNR steroid injection	Ultrasound	the patient who are treated with steroid (dexamethasone) injection through selected cervical spinal nerve block approach guided by ultrasound and C arm.
UCTF steroid injection	C arm	the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided by ultrasound and C arm.
XCTF steroid injection	C arm	the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided only by C arm.
USNR steroid injection	Dexamethasone	the patient who are treated with steroid (dexamethasone) injection through selected cervical spinal nerve block approach guided by ultrasound and C arm.
UCTF steroid injection	Dexamethasone	the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided by ultrasound and C arm.
XCTF steroid injection	Dexamethasone	the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided only by C arm.

Primary Outcome Measures

Name	Time	Method
change of pain severity rated on a Visual Analog Scale (VAS)	1 day before, 1day after, 1week after and 4 weeks after the intervention

Secondary Outcome Measures

Name	Time	Method
change of medication use rated on Medication Quantitative Scale (MQS)	1 day before, 1day after, 1week after and 4 weeks after the intervention
change of neck actives rated on Neck Disability Index (NDI)	1 day before, 1day after, 1week after and 4 weeks after the intervention