Overview

This trial is active, not recruiting.

Condition cervical radiculopathy
Treatments snr steroid (dexamethasone) injection, ctf steroid (dexamethasone) injection, dexamethasone, ultrasound, c arm
Sponsor Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
Start date January 2014
End date January 2015
Trial size 60 participants
Trial identifier NCT02295709, 2014-46

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
the patient who are treated with steroid (dexamethasone) injection through selected cervical spinal nerve block approach guided by ultrasound and C arm.
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)
dexamethasone DXM
One of the most efficient steroids
ultrasound
Ultrasound (S-Nerve; SonoSite, Bothell, Wash), Probe 9L (6 MHz, SonoSite, Bothell, Wash)
c arm
the needle position will be re-confirmed by C arm C arm (Philips Healthcare, Best, the Netherlands)
(Experimental)
the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided by ultrasound and C arm.
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)
dexamethasone DXM
One of the most efficient steroids
ultrasound
Ultrasound (S-Nerve; SonoSite, Bothell, Wash), Probe 9L (6 MHz, SonoSite, Bothell, Wash)
c arm
the needle position will be re-confirmed by C arm C arm (Philips Healthcare, Best, the Netherlands)
(Experimental)
the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided only by C arm.
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)
dexamethasone DXM
One of the most efficient steroids
c arm
the needle position will be re-confirmed by C arm C arm (Philips Healthcare, Best, the Netherlands)

Primary Outcomes

Measure
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

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title Cervical Transforaminal Injection of Steroids Guided by Ultrasound
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Shanghai Jiao Tong University Affiliated Sixth People’s Hospital.