Cervical Transforaminal Injection of Steroids Guided by Ultrasound
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Primary Endpoint
- change of pain severity rated on a Visual Analog Scale (VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: SNR steroid (dexamethasone) injection (Procedure)
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.
Intervention: Dexamethasone (Drug)
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.
Intervention: Ultrasound (Device)
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.
Intervention: C arm (Radiation)
UCTF steroid injection
the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided by ultrasound and C arm.
Intervention: CTF steroid (dexamethasone) injection (Procedure)
UCTF steroid injection
the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided by ultrasound and C arm.
Intervention: Dexamethasone (Drug)
UCTF steroid injection
the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided by ultrasound and C arm.
Intervention: Ultrasound (Device)
UCTF steroid injection
the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided by ultrasound and C arm.
Intervention: C arm (Radiation)
XCTF steroid injection
the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided only by C arm.
Intervention: CTF steroid (dexamethasone) injection (Procedure)
XCTF steroid injection
the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided only by C arm.
Intervention: Dexamethasone (Drug)
XCTF steroid injection
the patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided only by C arm.
Intervention: C arm (Radiation)
Outcomes
Primary Outcomes
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
- change of medication use rated on Medication Quantitative Scale (MQS)(1 day before, 1day after, 1week after and 4 weeks after the intervention)
- change of neck actives rated on Neck Disability Index (NDI)(1 day before, 1day after, 1week after and 4 weeks after the intervention)
Investigators
Dongping Du
Pain Management Center
Shanghai Jiao Tong University Affiliated Sixth People's Hospital