A Phase 4 interventional study of Transforaminal ESI with dexamethasone and Transforaminal catheter-targeted ESI with triamcinolone in Cervical Radiculopathy, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-11-25.
Sponsored by University of Utah · Phase 4, Interventional, and Treatment
Do cervical epidural steroid injections done by transforaminal catheter targeted approach improve pain and function in patients with cervical radicular pain?
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.
498 studies on the registry are indexed under Radiculopathy; 144 are open to participants now.
This study's enrollment of 120 is above the median of 60 across 385 interventional studies indexed under Radiculopathy.
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Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate
Procedure: Transforaminal ESI with dexamethasone · Drug: Dexamethasone Sodium Phosphate 10 MG/ML · Drug: Lidocaine
Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide
Procedure: Transforaminal catheter-targeted ESI with triamcinolone · Drug: Lidocaine · Drug: Triamcinolone Acetonide 40mg/mL
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).
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).
Drug page: Dexamethasone phosphate
Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1
1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
Also known as: Xylocaine
Drug page: Triamcinolone Acetonide
Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2
Also known as: Kenalog
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
Time frame: 1 month follow up
Neck Disability Index-5
Percentage of patients with \>30% improvement in Neck Disability Index-5 score.
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
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.
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")
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")
Time frame: 1 month, 3 month, 6 month, and 1 year follow up
| Milestone | Transforaminal ESI With Dexamethasone | Transforaminal Catheter-targeted ESI With Triamcinolone |
|---|---|---|
| Started | 60 | 60 |
| Completed | 60 | 57 |
| Not completed | 0 | 3 |
| Withdrew: Did not receive allocated intervention. | 0 | 3 |
The Percentage of Participants with Reduction of 50% or More of Neck and Arm Pain NRS score
| percentage of participants | Transforaminal ESI With Dexamethasone | Interlaminar Catheter-targeted ESI With Triamcinolone |
|---|---|---|
| The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score | 49.1 (36.4 to 62.0) | 68.5 (54.9 to 79.5) |
Percentage of patients with \>30% improvement in Neck Disability Index-5 score.
| percentage of participants | Transforaminal ESI With Dexamethasone | Transforaminal Catheter-targeted ESI With Triamcinolone |
|---|---|---|
| One month | 48 (35 to 61) | 62 (49 to 75) |
| Three month | 56 (43 to 69) | 58 (45 to 72) |
| Six month | 55 (41 to 69) | 56 (43 to 69) |
| One year | 47 (33 to 61) | 60 (47 to 74) |
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.
| percentage of participants | Transforaminal ESI With Dexamethasone | Transforaminal Catheter-targeted ESI With Triamcinolone |
|---|---|---|
| One month | 16 (6 to 25) | 19 (8 to 29) |
| Three month | 20 (9 to 31) | 17 (7 to 27) |
| Six month | 15 (5 to 24) | 19 (8 to 29) |
| One year | 7 (4 to 22) | 8 (6 to 27) |
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")
| percentage of participants | Transforaminal ESI With Dexamethasone | Transforaminal Catheter-targeted ESI With Triamcinolone |
|---|---|---|
| One month | 41 (28 to 54) | 59 (46 to 72) |
| Three months | 42 (28 to 56) | 57 (43 to 70) |
| Six months | 55 (40 to 69) | 53 (39 to 67) |
| One year | 57 (42 to 73) | 61 (45 to 76) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Transforaminal ESI With Dexamethasone | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
| Interlaminar Catheter-targeted ESI With Triamcinolone | 0/57 (0%) | 0/57 (0%) | 0/57 (0%) |
| Age, Categorical(Participants) | Transforaminal ESI With Dexamethasone | Interlaminar Catheter-targeted ESI With Triamcinolone | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 51 | 48 | 99 |
| >=65 years | 9 | 9 | 18 |
| Sex: Female, Male(Participants) | Transforaminal ESI With Dexamethasone | Interlaminar Catheter-targeted ESI With Triamcinolone | Total |
|---|---|---|---|
| Female | 34 | 32 | 66 |
| Male | 26 | 25 | 51 |
| Race and Ethnicity Not Collected(Participants) | Transforaminal ESI With Dexamethasone | Interlaminar Catheter-targeted ESI With Triamcinolone | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Transforaminal ESI With Dexamethasone | Interlaminar Catheter-targeted ESI With Triamcinolone | Total |
|---|---|---|---|
| United States | 60 | 57 | 117 |
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Studies of the drugs tested here: Dexamethasone phosphate · Triamcinolone Acetonide