Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04544683
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2020-08-28
Brief Title:
Effectiveness of Cervical Transforaminal Epidural Steroid Injection
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
The Effectiveness of Cervical Transforaminal Epidural Steroid Injection for the Treatment of Cervical Radicular Pain A Prospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study Purpose
This study is intended to monitor outcomes for 1 year following cervical TFESI Based on current clinic volume and enrollment rates into a current study of cervical epidural injections that is nearing completion we conservatively estimate a study enrollment period of 18 months and a total period of 25 years from enrollment to final follow-up data collection If the study were to theoretically start enrolling in July 2019 we would anticipate completion by February 2022
Objectives
1 Determine the proportion of patients with an 80 or greater improvement in arm and neck numerical rating scale pain NRS score following an initial cervical transforaminal steroid injection TFESI at 4 weeks post-injection and the duration of response up to 12 months
2 Determine the proportion of patients with a 50-79 improvement in arm and neck NRS score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months
3 Determine the proportion of patients with less than 50 improvement in arm and neck NRS score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months
4 Determine the proportion of patients with an initial injection plus up to 3 additional injections that maintain 80 or greater as well as 50-79 improvement in arm and neck NRS score for up to 12 months
5 Determine the proportion of patients with a clinically significant change in function defined by a minimally clinically significant change MCIC 10 point improvement or 30 improvement in Neck Disability Index NDI score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months
6 Determine the proportion of patients with clinically significant improvement in the Medication Quantification Scale MQS III score 68 point change equivalent to 10 oral morphine equivalents following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months
6 Determine the proportion of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool EQ-5D defined by 003 following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months
7 Compare patient demographic clinical and imaging characteristics between response groups and perform predictive modeling to better understand variables that increase the likelihood of a successful clinical outcome
8 Report adverse effects
This study is intended to monitor outcomes for 1 year following cervical TFESI Based on current clinic volume and enrollment rates into a current study of cervical epidural injections that is nearing completion we conservatively estimate a study enrollment period of 18 months and a total period of 25 years from enrollment to final follow-up data collection If the study were to theoretically start enrolling in July 2019 we would anticipate completion by February 2022
Objectives
1 Determine the proportion of patients with an 80 or greater improvement in arm and neck numerical rating scale pain NRS score following an initial cervical transforaminal steroid injection TFESI at 4 weeks post-injection and the duration of response up to 12 months
2 Determine the proportion of patients with a 50-79 improvement in arm and neck NRS score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months
3 Determine the proportion of patients with less than 50 improvement in arm and neck NRS score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months
4 Determine the proportion of patients with an initial injection plus up to 3 additional injections that maintain 80 or greater as well as 50-79 improvement in arm and neck NRS score for up to 12 months
5 Determine the proportion of patients with a clinically significant change in function defined by a minimally clinically significant change MCIC 10 point improvement or 30 improvement in Neck Disability Index NDI score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months
6 Determine the proportion of patients with clinically significant improvement in the Medication Quantification Scale MQS III score 68 point change equivalent to 10 oral morphine equivalents following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months
6 Determine the proportion of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool EQ-5D defined by 003 following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months
7 Compare patient demographic clinical and imaging characteristics between response groups and perform predictive modeling to better understand variables that increase the likelihood of a successful clinical outcome
8 Report adverse effects
Detailed Description:
Background and Project Justification Neck pain is now the fourth leading cause of years lost to disability shortly after back pain depression and arthralgia Cervical radiculopathy a common cause of neck and radiating arm pain is estimated to afflict 83100000 individuals yearly Age-related cervical spondylosis and disc herniation are the most common causes with the C6 and C7 nerve roots most frequently affected In general patients who experience new onset radicular pain tend to improve within 4-6 months with complete recovery in over 80 of patients by 24-36 months However a significant proportion of patients experience severe pain and associated functional impairment despite conservative care which often prompts physician directed interventions
Cervical transforaminal epidural steroid injection TFESI is a target-specific treatment for refractory radicular pain Analgesic mechanisms for epidural steroid administration include reducing inflammation at the nerve root reducing nociceptive input from somatic nerves stabilization of neural membranes and blockade of C fiber activity in the dorsal root ganglion Previously this procedure was associated with rare but catastrophic neurologic injury though to be related to inadvertent deposit of particulate steroid into the vertebral artery or radiculomedullary arteries both of which traverse through or close to the cervical neuroforamina Since the physician community has adopted new guidelines that include the use of only non-particulate steroid during cervical TFESI neurologic infarction has not been reported in the literature When the Spine Intervention Society SIS clinical practice guidelines are employed large cohort study demonstrates zero prevalence of serious complications associated with this procedure
While high-quality outcome literature demonstrates both efficacy and effectiveness for analogous use of this intervention in the lumbar spine far fewer studies have addressed clinical outcomes associated with cervical TFESI in which appropriate procedure technique outcome measurement data analysis and results interpretation have been reported Outcome literature reporting on the use of cervical TFESI is limited by small sample size retrospective design with loss of follow-up lack of categorical data analysis and a failure to stratify results by demographic and clinical variables that potentially influence pain and functional outcomes Further outcome literature reports on the effect of particulate steroid injectate during cervical TFESI is no longer relevant to appropriate clinical practice in the context of unequivocal guidelines Pragmatic studies with a cervical TFESI arm in which dexamethasone was use do allow for some insight regarding success rates associated with this procedure calculates of success rates in these studies arms demonstrate responder rates of 60 achieving 50 pain relief CI95 35-85 at 4 weeks 55 achieving 50 CI95 43-67 at 8 weeks and 65 achieving 50 at 12 weeks CI95 48-81 These responder rates are encouraging but limited by wide 95 confidence intervals due to small sample size Prior systematic review has concluded that the evidence for treatment benefit of radicular pain by cervical TFESI is of very low quality due to multiple limitations in study design introducing risk of bias but does overall suggest approximately 50 patients experience 50 relief of radicular pain for at least 4 weeks after cervical TFESI
Additional clinical outcome literature is needed particularly given recent policy decisions such as that of Oregon State in relation to ending coverage of epidural steroid injections at any spinal level Without expansion of the evidence-basis for this important procedure there is a risk that this treatment option may be taken away from patients suffering from cervical radicular pain by further policy change A sham-controlled trial similar to the Ghahreman study would be ideal however due to cost considerations germane to a study designed and conducted in a manner that would prevent any possible criticism from the larger medical community we instead propose a high-quality large prospective cohort study as a significant contribution to the literature Even the best designed trials such as Dreyfuss 2006 study have been underpowered to definitively demonstrate effectiveness notably the lower bound of the 95 confidence interval of the proportion of treatment responders in this study was 35 The investigators aim to conduct a large enough cohort study narrow the 95 confidence interval of the proportion of responders substantially Preliminary data from our center demonstrates a responder rate of 55 at 4-week follow-up n22 based on a definition of 50 improvement in index pain Appendix A These data represent analysis of consecutive patients who underwent cervical TFESI for unilateral radicular pain as a part of a different prospective outcome study at our center nearing completion This responder rate represents a conservative estimate of what might be expected in the proposed work as the current study includes less stringent inclusion and exclusion criteria
Further the investigators intend to use the results of this study as foundational data from which to propose a randomized controlled study through a large federal funding mechanism It is imperative that such a trial be conducted by investigators who are experienced with this procedure and understand the appropriate standards for the design and interpretation of the results of a study of a treatment intervention for pain Our spine research group is well-positioned for this and we absolutely welcome the input and mentorship of the Spine Intervention Society Research Division Board of Directors and other leadership towards this mutual goal
Cervical transforaminal epidural steroid injection TFESI is a target-specific treatment for refractory radicular pain Analgesic mechanisms for epidural steroid administration include reducing inflammation at the nerve root reducing nociceptive input from somatic nerves stabilization of neural membranes and blockade of C fiber activity in the dorsal root ganglion Previously this procedure was associated with rare but catastrophic neurologic injury though to be related to inadvertent deposit of particulate steroid into the vertebral artery or radiculomedullary arteries both of which traverse through or close to the cervical neuroforamina Since the physician community has adopted new guidelines that include the use of only non-particulate steroid during cervical TFESI neurologic infarction has not been reported in the literature When the Spine Intervention Society SIS clinical practice guidelines are employed large cohort study demonstrates zero prevalence of serious complications associated with this procedure
While high-quality outcome literature demonstrates both efficacy and effectiveness for analogous use of this intervention in the lumbar spine far fewer studies have addressed clinical outcomes associated with cervical TFESI in which appropriate procedure technique outcome measurement data analysis and results interpretation have been reported Outcome literature reporting on the use of cervical TFESI is limited by small sample size retrospective design with loss of follow-up lack of categorical data analysis and a failure to stratify results by demographic and clinical variables that potentially influence pain and functional outcomes Further outcome literature reports on the effect of particulate steroid injectate during cervical TFESI is no longer relevant to appropriate clinical practice in the context of unequivocal guidelines Pragmatic studies with a cervical TFESI arm in which dexamethasone was use do allow for some insight regarding success rates associated with this procedure calculates of success rates in these studies arms demonstrate responder rates of 60 achieving 50 pain relief CI95 35-85 at 4 weeks 55 achieving 50 CI95 43-67 at 8 weeks and 65 achieving 50 at 12 weeks CI95 48-81 These responder rates are encouraging but limited by wide 95 confidence intervals due to small sample size Prior systematic review has concluded that the evidence for treatment benefit of radicular pain by cervical TFESI is of very low quality due to multiple limitations in study design introducing risk of bias but does overall suggest approximately 50 patients experience 50 relief of radicular pain for at least 4 weeks after cervical TFESI
Additional clinical outcome literature is needed particularly given recent policy decisions such as that of Oregon State in relation to ending coverage of epidural steroid injections at any spinal level Without expansion of the evidence-basis for this important procedure there is a risk that this treatment option may be taken away from patients suffering from cervical radicular pain by further policy change A sham-controlled trial similar to the Ghahreman study would be ideal however due to cost considerations germane to a study designed and conducted in a manner that would prevent any possible criticism from the larger medical community we instead propose a high-quality large prospective cohort study as a significant contribution to the literature Even the best designed trials such as Dreyfuss 2006 study have been underpowered to definitively demonstrate effectiveness notably the lower bound of the 95 confidence interval of the proportion of treatment responders in this study was 35 The investigators aim to conduct a large enough cohort study narrow the 95 confidence interval of the proportion of responders substantially Preliminary data from our center demonstrates a responder rate of 55 at 4-week follow-up n22 based on a definition of 50 improvement in index pain Appendix A These data represent analysis of consecutive patients who underwent cervical TFESI for unilateral radicular pain as a part of a different prospective outcome study at our center nearing completion This responder rate represents a conservative estimate of what might be expected in the proposed work as the current study includes less stringent inclusion and exclusion criteria
Further the investigators intend to use the results of this study as foundational data from which to propose a randomized controlled study through a large federal funding mechanism It is imperative that such a trial be conducted by investigators who are experienced with this procedure and understand the appropriate standards for the design and interpretation of the results of a study of a treatment intervention for pain Our spine research group is well-positioned for this and we absolutely welcome the input and mentorship of the Spine Intervention Society Research Division Board of Directors and other leadership towards this mutual goal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None