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Cervical Transforaminal Injection of Steroids Guided by Ultrasound

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ClinicalTrials.gov Identifier: NCT02295709
Recruitment Status : Unknown
Verified November 2014 by Dongping Du, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 20, 2014
Last Update Posted : November 21, 2014
Sponsor:
Information provided by (Responsible Party):
Dongping Du, 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.

Condition or disease Intervention/treatment Phase
Cervical Radiculopathy Procedure: SNR steroid (dexamethasone) injection Procedure: CTF steroid (dexamethasone) injection Drug: Dexamethasone Device: Ultrasound Radiation: C arm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Cervical Transforaminal Injection of Steroids Guided by Ultrasound
Study Start Date : January 2014
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: USNR steroid injection
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

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)


Drug: Dexamethasone
One of the most efficient steroids
Other Name: DXM

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)

Experimental: UCTF steroid injection
the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided by ultrasound and C arm.
Procedure: 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
Other Name: DXM

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)

Experimental: XCTF steroid injection
the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided only by C arm.
Procedure: 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
Other Name: DXM

Radiation: C arm
the needle position will be re-confirmed by C arm C arm (Philips Healthcare, Best, the Netherlands)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Responsible Party: Dongping Du, Pain Management Center, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
ClinicalTrials.gov Identifier: NCT02295709     History of Changes
Other Study ID Numbers: 2014-46
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: November 2014

Keywords provided by Dongping Du, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital:
ultrasound
cervical Transformational Epidural Steroid Injection

Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Agents
Radiculopathy
Neuromuscular Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action