Cervical RadiculopathyPhase 4NCT03382821
Comparative Trial Via Tranforaminal Approach Versus Epidural Catheter Via Interlaminar Approach
A Phase 4 study testing Transforaminal ESI with dexamethasone, Transforaminal catheter-targeted ESI with triamcinolone and Dexamethasone Sodium Phosphate 10 MG/ML in people with Cervical Radiculopathy, run by University of Utah at 1 site in United States.
Trial summary
Do cervical epidural steroid injections done by transforaminal catheter targeted approach improve pain and function in patients with cervical radicular pain? 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?
- Transforaminal ESI with dexamethasone, Transforaminal catheter-targeted ESI with triamcinolone and Dexamethasone Sodium Phosphate 10 MG/ML
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2017to 19 Aug 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18-80.
- Clinical diagnosis of unilateral C4-C8 radicular pain.
- Magnetic resonance imaging pathology consistent with clinical symptoms/signs.
- Numerical Rating Scale (NRS) pain score of 4 or higher.
- Pain duration of more than 6 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care).
Who cannot join
- Refusal to participate, provide consent, or provide follow-up information for the 6-month duration of the study.
- Contraindications to Cervical Epidural Steroid Iinjection (CESI) (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to medications used for Cervical epidural steroid injection (CESI), and pregnancy).
- Cervical spinal cord lesions; cerebrovascular, demyelinating, or other neuro-muscular muscular disease.
- Current glucocorticoid use or Epidural Steroid Injection (ESI) within past 6 months.
- Prior cervical spine surgery.
- Patient request for or requirement of conscious sedation for the injection procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
About this study
Official title: A Prospective Randomized Comparative Trial of Targeted Injection Via a Transforaminal Approach With Dexamethasone Versus an Epidural Catheter Via an Interlaminar Approach With Particulate Steroid for the Treatment of Cervical Radicular Pain
Do cervical epidural steroid injections done by transforaminal catheter targeted approach improve pain and function in patients with cervical radicular pain?
Read the detailed description
Two distinct techniques used to administer epidural steroids specifically to the nerve root affected in a radicular pain syndrome, which include transforaminal access at the level of pathology and interlaminar interlaminar access at the C7-T1 level with subsequent advancement of an epidural cathether to the level of pathology. Use of an epidural catheter is necessary in order to achieve a targeted injection via an interlaminar approach in order to prevent dural puncture or direct spinal cord trauma. Anatomic studies confirm the distance between the ligamentum flavum and dura is on average, 4 mm at the C7-T1 or C6-C7 levels, but 1mm or smaller at C5-C6 and more rostral levels. Therefore, there is likely greater risk of dural puncture and spinal cord injury when "targeting" steroid delivery using only the interlaminar technique directly at the level where pathology is located (C4-C5, or C5-C6, for example). Thus, the interlaminar placement of a needle rostral to the C6-C7 level has been strongly discouraged.
Both the transforaminal injection approach and the targeted catheter approach demonstrate effectiveness. Studies have demonstrated the effectiveness of transforaminal epidural steroid injection for the treatment of cervical radicular pain. Our own recent work demonstrates the clinical effectiveness of the catheter-based targeted approach. However, these two approaches have never been directly compared. Thus, we aim to compare the differences in pain reduction, medication utilization, functional outcomes, patient satisfaction, and surgical rate reduction between these two approaches to the treatment of cervical radicular pain.
Cervical radicular pain is a common syndrome, often treated with epidural steroid injection (ESI). An approach that targets the therapeutic agent, corticosteroid, at the site of spinal pathology can be performed via a transforaminal approach or via a interlaminar approach at C7-T1 with subsequent epidural catheter advancement to the symptomatic level. There are no universal guidelines that recommend the use of one technique over the other. We will directly compare the clinical effectiveness of these two approaches as measured by pain reduction, medication utilization, functional outcomes, patient satisfaction, and surgical rate reduction. The results of this study will potentially influence clinical practice recommendations regarding the treatment of cervical radicular pain. If one technique proves superior, instating this technique will have implications potentially for reducing opioid use, surgery and other healthcare utilization, and general healthcare cost related to the treatment of cervical radicular pain.
- Conditions
- Cervical Radiculopathy
- Being tested
- Transforaminal ESI with dexamethasone, Transforaminal catheter-targeted ESI with triamcinolone, Dexamethasone Sodium Phosphate 10 MG/ML, Lidocaine, Triamcinolone Acetonide 40mg/mL
- Keywords
- cervical epidural steroid injection, transforaminal approach, epidural catheter targeted, interlaminar approach, cervical radicular pain
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforaminal ESI with dexamethasoneProcedure or surgery
Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL).
Transforaminal catheter-targeted ESI with triamcinoloneProcedure or surgery
Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL).
Dexamethasone Sodium Phosphate 10 MG/MLDrug
Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1
LidocaineDrug
Also called Xylocaine
1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
Triamcinolone Acetonide 40mg/mLDrug
Also called Kenalog
Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2
| Study group | Role | What they receive |
|---|---|---|
| Transforaminal ESI with dexamethasone | Active comparator | Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate Receives: Procedure: Transforaminal ESI with dexamethasone; Drug: Dexamethasone Sodium Phosphate 10 MG/ML; Drug: Lidocaine |
| Transforaminal catheter-targeted ESI with triamcinolone | Active comparator | Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide Receives: Procedure: Transforaminal catheter-targeted ESI with triamcinolone; Drug: Lidocaine; Drug: Triamcinolone Acetonide 40mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score
The Percentage of Participants with Reduction of 50% or More of Neck and Arm Pain NRS score
Measured: 1 month follow up
Secondary outcomes (3)
Neck Disability Index-5
Percentage of patients with >30% improvement in Neck Disability Index-5 score.
Measured: 1 month, 3 month, 6 month, and 1 year follow up
Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III
The Medication Quantification Scale (MQS) is an instrument used for clinical and research applications for quantifying medication regimen use in chronic pain populations. A 6.8 point reduction is considered equivalent to 10 morphine eqivalents.
Measured: 1 month, 3 month, 6 month, and 1 year follow up
The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating "Much Improved" and "Very Much Improved")
Patient Global Impression of Change is a scale which measures participant reported satisfaction after an intervention. The outcome was measured as the percent of patients reporting a PGIC score of 6-7 (indicating "much improved" and "very much improved")
Measured: 1 month, 3 month, 6 month, and 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start15 Sep 2017
- Primary completion15 Apr 2020
- Study completion19 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, comparative trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Epimed
- Responsible party
- Principal investigator, Zack McCormick, University of Utah
- Investigators
- Zachary L McCormick, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382821
- Sponsor's protocol ID
- 105766
- Status last verified
- Nov 2022
- First submitted
- 4 Dec 2017
- Last updated
- 25 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Radhakrishnan K, Litchy WJ, O'Fallon WM, Kurland LT. Epidemiology of cervical radiculopathy. A population-based study from Rochester, Minnesota, 1976 through 1990. Brain. 1994 Apr;117 ( Pt 2):325-35. doi: 10.1093/brain/117.2.325.
PubMed 8186959Carette S, Fehlings MG. Clinical practice. Cervical radiculopathy. N Engl J Med. 2005 Jul 28;353(4):392-9. doi: 10.1056/NEJMcp043887. No abstract available.
PubMed 16049211Heckmann JG, Lang CJ, Zobelein I, Laumer R, Druschky A, Neundorfer B. Herniated cervical intervertebral discs with radiculopathy: an outcome study of conservatively or surgically treated patients. J Spinal Disord. 1999 Oct;12(5):396-401.
PubMed 10549703Johnston MM, Jordan SE, Charles AC. Pain referral patterns of the C1 to C3 nerves: implications for headache disorders. Ann Neurol. 2013 Jul;74(1):145-8. doi: 10.1002/ana.23869. Epub 2013 Jun 17.
PubMed 23424170Mizutamari M, Sei A, Tokiyoshi A, Fujimoto T, Taniwaki T, Togami W, Mizuta H. Corresponding scapular pain with the nerve root involved in cervical radiculopathy. J Orthop Surg (Hong Kong). 2010 Dec;18(3):356-60. doi: 10.1177/230949901001800320.
PubMed 21187551Rhee JM, Yoon T, Riew KD. Cervical radiculopathy. J Am Acad Orthop Surg. 2007 Aug;15(8):486-94. doi: 10.5435/00124635-200708000-00005.
PubMed 17664368Malanga GA. The diagnosis and treatment of cervical radiculopathy. Med Sci Sports Exerc. 1997 Jul;29(7 Suppl):S236-45. doi: 10.1097/00005768-199707001-00006.
PubMed 9247921Renfrew DL, Moore TE, Kathol MH, el-Khoury GY, Lemke JH, Walker CW. Correct placement of epidural steroid injections: fluoroscopic guidance and contrast administration. AJNR Am J Neuroradiol. 1991 Sep-Oct;12(5):1003-7.
PubMed 1719788Mehta M, Salmon N. Extradural block. Confirmation of the injection site by X-ray monitoring. Anaesthesia. 1985 Oct;40(10):1009-12. doi: 10.1111/j.1365-2044.1985.tb10558.x.
PubMed 4061788Stojanovic MP, Vu TN, Caneris O, Slezak J, Cohen SP, Sang CN. The role of fluoroscopy in cervical epidural steroid injections: an analysis of contrast dispersal patterns. Spine (Phila Pa 1976). 2002 Mar 1;27(5):509-14. doi: 10.1097/00007632-200203010-00011.
PubMed 11880836Van Zundert J, Huntoon M, Patijn J, Lataster A, Mekhail N, van Kleef M; Pain Practice. 4. Cervical radicular pain. Pain Pract. 2010 Jan-Feb;10(1):1-17. doi: 10.1111/j.1533-2500.2009.00319.x. Epub 2009 Oct 5.
PubMed 19807874Johansson A, Hao J, Sjolund B. Local corticosteroid application blocks transmission in normal nociceptive C-fibres. Acta Anaesthesiol Scand. 1990 Jul;34(5):335-8. doi: 10.1111/j.1399-6576.1990.tb03097.x.
PubMed 2167604Benyamin RM, Singh V, Parr AT, Conn A, Diwan S, Abdi S. Systematic review of the effectiveness of cervical epidurals in the management of chronic neck pain. Pain Physician. 2009 Jan-Feb;12(1):137-57.
PubMed 19165300Stav A, Ovadia L, Sternberg A, Kaadan M, Weksler N. Cervical epidural steroid injection for cervicobrachialgia. Acta Anaesthesiol Scand. 1993 Aug;37(6):562-6. doi: 10.1111/j.1399-6576.1993.tb03765.x.
PubMed 8213020Castagnera L, Maurette P, Pointillart V, Vital JM, Erny P, Senegas J. Long-term results of cervical epidural steroid injection with and without morphine in chronic cervical radicular pain. Pain. 1994 Aug;58(2):239-243. doi: 10.1016/0304-3959(94)90204-6.
PubMed 7816491
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparative Trial of Targeted Injection Via a Transforaminal Approach With Dexamethasone Versus an Epidural Catheter Via an Interlaminar Approach With Particulate Steroid for the Treatment of Cervical Radicular Pain
- ClinicalTrials.gov ID
- NCT03382821
- Acronym / sponsor ID
- 105766
- Conditions
- Cervical Radiculopathy
- Keywords
- cervical epidural steroid injection, transforaminal approach, epidural catheter targeted, interlaminar approach, cervical radicular pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Epimed
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 19 Aug 2020 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Posted 22 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Do cervical epidural steroid injections done by transforaminal catheter targeted approach improve pain and function in patients with cervical radicular pain?
Detailed description
Two distinct techniques used to administer epidural steroids specifically to the nerve root affected in a radicular pain syndrome, which include transforaminal access at the level of pathology and interlaminar interlaminar access at the C7-T1 level with subsequent advancement of an epidural cathether to the level of pathology. Use of an epidural catheter is necessary in order to achieve a targeted injection via an interlaminar approach in order to prevent dural puncture or direct spinal cord trauma. Anatomic studies confirm the distance between the ligamentum flavum and dura is on average, 4 mm at the C7-T1 or C6-C7 levels, but 1mm or smaller at C5-C6 and more rostral levels. Therefore, there is likely greater risk of dural puncture and spinal cord injury when "targeting" steroid delivery using only the interlaminar technique directly at the level where pathology is located (C4-C5, or C5-C6, for example). Thus, the interlaminar placement of a needle rostral to the C6-C7 level has been strongly discouraged.
Both the transforaminal injection approach and the targeted catheter approach demonstrate effectiveness. Studies have demonstrated the effectiveness of transforaminal epidural steroid injection for the treatment of cervical radicular pain. Our own recent work demonstrates the clinical effectiveness of the catheter-based targeted approach. However, these two approaches have never been directly compared. Thus, we aim to compare the differences in pain reduction, medication utilization, functional outcomes, patient satisfaction, and surgical rate reduction between these two approaches to the treatment of cervical radicular pain.
Cervical radicular pain is a common syndrome, often treated with epidural steroid injection (ESI). An approach that targets the therapeutic agent, corticosteroid, at the site of spinal pathology can be performed via a transforaminal approach or via a interlaminar approach at C7-T1 with subsequent epidural catheter advancement to the symptomatic level. There are no universal guidelines that recommend the use of one technique over the other. We will directly compare the clinical effectiveness of these two approaches as measured by pain reduction, medication utilization, functional outcomes, patient satisfaction, and surgical rate reduction. The results of this study will potentially influence clinical practice recommendations regarding the treatment of cervical radicular pain. If one technique proves superior, instating this technique will have implications potentially for reducing opioid use, surgery and other healthcare utilization, and general healthcare cost related to the treatment of cervical radicular pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, randomized, comparative trial
| Arm | Type | Receives |
|---|---|---|
| Transforaminal ESI with dexamethasone | Active comparator | Procedure: Transforaminal ESI with dexamethasone, Drug: Dexamethasone Sodium Phosphate 10 MG/ML, Drug: LidocaineGroup 1: Transforaminal cervical ESI with dexamethasone sodium phosphate |
| Transforaminal catheter-targeted ESI with triamcinolone | Active comparator | Procedure: Transforaminal catheter-targeted ESI with triamcinolone, Drug: Lidocaine, Drug: Triamcinolone Acetonide 40mg/mLGroup 2: Catheter-targeted cervical ESI with triamcinolone acetonide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80.
- Clinical diagnosis of unilateral C4-C8 radicular pain.
- Magnetic resonance imaging pathology consistent with clinical symptoms/signs.
- Numerical Rating Scale (NRS) pain score of 4 or higher.
- Pain duration of more than 6 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care).
Key exclusion criteria (6 listed)
- Refusal to participate, provide consent, or provide follow-up information for the 6-month duration of the study.
- Contraindications to Cervical Epidural Steroid Iinjection (CESI) (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to medications used for Cervical epidural steroid injection (CESI), and pregnancy).
- Cervical spinal cord lesions; cerebrovascular, demyelinating, or other neuro-muscular muscular disease.
- Current glucocorticoid use or Epidural Steroid Injection (ESI) within past 6 months.
- Prior cervical spine surgery.
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 |
|---|---|---|
| Transforaminal ESI with dexamethasoneCatheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL). | Procedure or surgery | Transforaminal ESI with dexamethasone |
| Transforaminal catheter-targeted ESI with triamcinoloneCatheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL). | Procedure or surgery | Transforaminal catheter-targeted ESI with triamcinolone |
| Dexamethasone Sodium Phosphate 10 MG/MLTransforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1 | Drug | Transforaminal ESI with dexamethasone |
| LidocaineAlso: Xylocaine1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2 | Drug | Transforaminal ESI with dexamethasone, Transforaminal catheter-targeted ESI with triamcinolone |
| Triamcinolone Acetonide 40mg/mLAlso: KenalogTransforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2 | Drug | Transforaminal catheter-targeted ESI with triamcinolone |
Primary outcome
The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score
Time frame: 1 month follow up
The Percentage of Participants with Reduction of 50% or More of Neck and Arm Pain NRS score
3 secondary outcomes
Neck Disability Index-5
Time frame: 1 month, 3 month, 6 month, and 1 year follow up
Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III
Time frame: 1 month, 3 month, 6 month, and 1 year follow up
The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating "Much Improved" and "Very Much Improved")
Time frame: 1 month, 3 month, 6 month, and 1 year follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8186959Radhakrishnan K, Litchy WJ, O'Fallon WM, Kurland LT. Epidemiology of cervical radiculopathy. A population-based study from Rochester, Minnesota, 1976 through 1990. Brain. 1994 Apr;117 ( Pt 2):325-35. doi: 10.1093/brain/117.2.325.
- Background: PubMed 16049211Carette S, Fehlings MG. Clinical practice. Cervical radiculopathy. N Engl J Med. 2005 Jul 28;353(4):392-9. doi: 10.1056/NEJMcp043887. No abstract available.
- Background: PubMed 10549703Heckmann JG, Lang CJ, Zobelein I, Laumer R, Druschky A, Neundorfer B. Herniated cervical intervertebral discs with radiculopathy: an outcome study of conservatively or surgically treated patients. J Spinal Disord. 1999 Oct;12(5):396-401.
- Background: PubMed 23424170Johnston MM, Jordan SE, Charles AC. Pain referral patterns of the C1 to C3 nerves: implications for headache disorders. Ann Neurol. 2013 Jul;74(1):145-8. doi: 10.1002/ana.23869. Epub 2013 Jun 17.
- Background: PubMed 21187551Mizutamari M, Sei A, Tokiyoshi A, Fujimoto T, Taniwaki T, Togami W, Mizuta H. Corresponding scapular pain with the nerve root involved in cervical radiculopathy. J Orthop Surg (Hong Kong). 2010 Dec;18(3):356-60. doi: 10.1177/230949901001800320.
- Background: PubMed 17664368Rhee JM, Yoon T, Riew KD. Cervical radiculopathy. J Am Acad Orthop Surg. 2007 Aug;15(8):486-94. doi: 10.5435/00124635-200708000-00005.
- Background: PubMed 9247921Malanga GA. The diagnosis and treatment of cervical radiculopathy. Med Sci Sports Exerc. 1997 Jul;29(7 Suppl):S236-45. doi: 10.1097/00005768-199707001-00006.
- Background: PubMed 1719788Renfrew DL, Moore TE, Kathol MH, el-Khoury GY, Lemke JH, Walker CW. Correct placement of epidural steroid injections: fluoroscopic guidance and contrast administration. AJNR Am J Neuroradiol. 1991 Sep-Oct;12(5):1003-7.
- Background: PubMed 4061788Mehta M, Salmon N. Extradural block. Confirmation of the injection site by X-ray monitoring. Anaesthesia. 1985 Oct;40(10):1009-12. doi: 10.1111/j.1365-2044.1985.tb10558.x.
- Background: PubMed 11880836Stojanovic MP, Vu TN, Caneris O, Slezak J, Cohen SP, Sang CN. The role of fluoroscopy in cervical epidural steroid injections: an analysis of contrast dispersal patterns. Spine (Phila Pa 1976). 2002 Mar 1;27(5):509-14. doi: 10.1097/00007632-200203010-00011.
- Background: PubMed 19807874Van Zundert J, Huntoon M, Patijn J, Lataster A, Mekhail N, van Kleef M; Pain Practice. 4. Cervical radicular pain. Pain Pract. 2010 Jan-Feb;10(1):1-17. doi: 10.1111/j.1533-2500.2009.00319.x. Epub 2009 Oct 5.
- Background: PubMed 2167604Johansson A, Hao J, Sjolund B. Local corticosteroid application blocks transmission in normal nociceptive C-fibres. Acta Anaesthesiol Scand. 1990 Jul;34(5):335-8. doi: 10.1111/j.1399-6576.1990.tb03097.x.
- Individual participant dataSharing planned: Undecided
Related trials for Cervical Radiculopathy
Recruiting
Ultrasound-Guided Electrical Dry Needling for Chronic Cervical Radiculopathy
Cervical Radiculopathy
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
Recruiting
Myo-Electrical and Nerve Root Function Response to Focused Extracorpeal Shock Wave in Cervical Radiculopathy
Cervical Radiculopathy
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
RecruitingObservational study
Cervical Spinal Cord Signal Abnormalities in Patients With Cervical Radicular Pain
Cervical Radiculopathy, Cervical Myelomalacia
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.
Zachary L McCormick, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transforaminal ESI with dexamethasone, Transforaminal catheter-targeted ESI with triamcinolone and Dexamethasone Sodium Phosphate 10 MG/ML in people with Cervical Radiculopathy, run by University of Utah at 1 site in United States.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score (time frame: 1 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03382821, which also lists 29 linked publications.
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 25 Nov 2022.