Cervical Radiculopathy
Conditions
Keywords
ultrasound, cervical Transformational Epidural Steroid Injection
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.
Interventions
PROCEDURESNR 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)
PROCEDURECTF 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)
DRUGDexamethasone
One of the most efficient steroids
DEVICEUltrasound
Ultrasound (S-Nerve; SonoSite, Bothell, Wash), Probe 9L (6 MHz, SonoSite, Bothell, Wash)
RADIATIONC arm
the needle position will be re-confirmed by C arm C arm (Philips Healthcare, Best, the Netherlands）
Sponsors
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| change of neck actives rated on Neck Disability Index (NDI) | 1 day before, 1day after, 1week after and 4 weeks after the intervention |
| change of medication use rated on Medication Quantitative Scale (MQS) | 1 day before, 1day after, 1week after and 4 weeks after the intervention |
Outcome results
None listed