Cervical Transforaminal Injection of Steroids Guided by Ultrasound

Cervical Radiculopathy Clinical Trial

Official title:

Cervical Transforaminal Injection of Steroids Guided by Ultrasound

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02295709
• Other study ID #: 2014-46
• Status: Active, not recruiting
• Phase: N/A
• First received: November 16, 2014
• Last updated: November 19, 2014
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: November 2014
• Source: Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Shanghai Jiao Tong University.
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

Intervention

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)
• 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)

Drug:
• Dexamethasone
One of the most efficient steroids

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of pain severity rated on a Visual Analog Scale (VAS)		1 day before, 1day after, 1week after and 4 weeks after the intervention	Yes
Secondary	change of neck actives rated on Neck Disability Index (NDI)		1 day before, 1day after, 1week after and 4 weeks after the intervention	Yes
Secondary	change of medication use rated on Medication Quantitative Scale (MQS)		1 day before, 1day after, 1week after and 4 weeks after the intervention	Yes