Cervical RadiculopathyNCT02295709
Cervical Transforaminal Injection of Steroids Guided by Ultrasound
A study testing SNR steroid (dexamethasone) injection, CTF steroid (dexamethasone) injection and Dexamethasone in people with Cervical Radiculopathy, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- SNR steroid (dexamethasone) injection, CTF steroid (dexamethasone) injection and Dexamethasone
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
- Being tested
- SNR steroid (dexamethasone) injection, CTF steroid (dexamethasone) injection, Dexamethasone, Ultrasound, C arm
- Keywords
- ultrasound, cervical Transformational Epidural Steroid Injection
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNR steroid (dexamethasone) injectionProcedure or surgery
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)
CTF steroid (dexamethasone) injectionProcedure or surgery
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)
DexamethasoneDrug
Also called DXM
One of the most efficient steroids
UltrasoundDevice
Ultrasound (S-Nerve; SonoSite, Bothell, Wash), Probe 9L (6 MHz, SonoSite, Bothell, Wash)
C armRadiation
the needle position will be re-confirmed by C arm C arm (Philips Healthcare, Best, the Netherlands）
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: CTF steroid (dexamethasone) injection; Drug: Dexamethasone; Radiation: C arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of pain severity rated on a Visual Analog Scale (VAS)
Measured: 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)
Measured: 1 day before, 1day after, 1week after and 4 weeks after the intervention
change of medication use rated on Medication Quantitative Scale (MQS)
Measured: 1 day before, 1day after, 1week after and 4 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongping Du, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295709
- Sponsor's protocol ID
- 2014-46
- Status last verified
- Nov 2014
- First submitted
- 16 Nov 2014
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Transforaminal Injection of Steroids Guided by Ultrasound
- ClinicalTrials.gov ID
- NCT02295709
- Acronym / sponsor ID
- 2014-46
- Conditions
- Cervical Radiculopathy
- Keywords
- ultrasound, cervical Transformational Epidural Steroid Injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| USNR steroid injection | Experimental | Procedure: SNR steroid (dexamethasone) injection, Drug: Dexamethasone, Device: Ultrasound, Radiation: C armthe patient who are treated with steroid (dexamethasone) injection through selected cervical spinal nerve block approach guided by ultrasound and C arm. |
| UCTF steroid injection | Experimental | Procedure: CTF steroid (dexamethasone) injection, Drug: Dexamethasone, Device: Ultrasound, Radiation: C armthe patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided by ultrasound and C arm. |
| XCTF steroid injection | Experimental | Procedure: CTF steroid (dexamethasone) injection, Drug: Dexamethasone, Radiation: C armthe patients who are treated with steroid (dexamethasone) injection through cervical transforaminal approach guided only by C arm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNR steroid (dexamethasone) injectiondeliver 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) | Procedure or surgery | USNR steroid injection |
| CTF steroid (dexamethasone) injectiondeliver 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) | Procedure or surgery | UCTF steroid injection, XCTF steroid injection |
| DexamethasoneAlso: DXMOne of the most efficient steroids | Drug | UCTF steroid injection, USNR steroid injection, XCTF steroid injection |
| UltrasoundUltrasound (S-Nerve; SonoSite, Bothell, Wash), Probe 9L (6 MHz, SonoSite, Bothell, Wash) | Device | UCTF steroid injection, USNR steroid injection |
| C armthe needle position will be re-confirmed by C arm C arm (Philips Healthcare, Best, the Netherlands） | Radiation | UCTF steroid injection, USNR steroid injection, XCTF steroid injection |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing SNR steroid (dexamethasone) injection, CTF steroid (dexamethasone) injection and Dexamethasone in people with Cervical Radiculopathy, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.