Cervical Transforaminal Injection of Steroids Guided by Ultrasound

Study Overview
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Brief Summary
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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.

Official Title
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Cervical Transforaminal Injection of Steroids Guided by Ultrasound

Conditions
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Cervical Radiculopathy

Intervention / Treatment
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* Procedure: SNR steroid (dexamethasone) injection
* Procedure: CTF steroid (dexamethasone) injection
* Drug: Dexamethasone
* Device: Ultrasound
* Radiation: C arm


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: USNR steroid injection<br>the patient who are treated with steroid (dexamethasone) injection through selected cervical spinal nerve block approach guided by ultrasound and C arm. | Procedure: SNR steroid (dexamethasone) injection<br>* 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)<br>Drug: Dexamethasone<br>* One of the most efficient steroids<br>* Other names: DXM;Device: Ultrasound<br>* Ultrasound (S-Nerve; SonoSite, Bothell, Wash), Probe 9L (6 MHz, SonoSite, Bothell, Wash)<br>Radiation: C arm<br>* the needle position will be re-confirmed by C arm C arm (Philips Healthcare, Best, the Netherlands）<br>|
| Experimental: UCTF steroid injection<br>the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided by ultrasound and C arm. | Procedure: CTF steroid (dexamethasone) injection<br>* 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)<br>Drug: Dexamethasone<br>* One of the most efficient steroids<br>* Other names: DXM;Device: Ultrasound<br>* Ultrasound (S-Nerve; SonoSite, Bothell, Wash), Probe 9L (6 MHz, SonoSite, Bothell, Wash)<br>Radiation: C arm<br>* the needle position will be re-confirmed by C arm C arm (Philips Healthcare, Best, the Netherlands）<br>|
| Experimental: XCTF steroid injection<br>the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided only by C arm. | Procedure: CTF steroid (dexamethasone) injection<br>* 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)<br>Drug: Dexamethasone<br>* One of the most efficient steroids<br>* Other names: DXM;Radiation: C arm<br>* the needle position will be re-confirmed by C arm C arm (Philips Healthcare, Best, the Netherlands）<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasound, cervical Transformational Epidural Steroid Injection