Cervical Transforaminal Injection of Steroids Guided by Ultrasound

NCT02295709 | Unknown DMC

• 1 other identifier: 2014-46
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Radiculopathy

Keywords

ultrasound; cervical Transformational Epidural Steroid Injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (3)

USNR steroid injection

EXPERIMENTAL

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; Drug: Dexamethasone; Device: Ultrasound; Radiation: C arm

UCTF steroid injection

EXPERIMENTAL

the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided by ultrasound and C arm.

Procedure: CTF steroid (dexamethasone) injection; Drug: Dexamethasone; Device: Ultrasound; Radiation: C arm

XCTF steroid injection

EXPERIMENTAL

the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided only by C arm.

Procedure: CTF steroid (dexamethasone) injection; Drug: Dexamethasone; Radiation: C arm

Interventions

SNR steroid (dexamethasone) injection PROCEDURE

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)

USNR steroid injection

CTF steroid (dexamethasone) injection PROCEDURE

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)

UCTF steroid injection; XCTF steroid injection

Dexamethasone DRUG

One of the most efficient steroids

Also known as: DXM

UCTF steroid injection; USNR steroid injection; XCTF steroid injection

Ultrasound DEVICE

Ultrasound (S-Nerve; SonoSite, Bothell, Wash), Probe 9L (6 MHz, SonoSite, Bothell, Wash)

UCTF steroid injection; USNR steroid injection

C arm RADIATION

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

UCTF steroid injection; USNR steroid injection; XCTF steroid injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead

MeSH Terms

Conditions

Radiculopathy

Interventions

Dexamethasone; Injections; Ultrasonography

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Drug Administration Routes; Drug Therapy; Therapeutics; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pain Management Center

Study Record Dates

• First Submitted: November 16, 2014
• First Posted: November 20, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 21, 2014

Record last verified: 2014-11