Cervical Radiculopathy
Conditions
Keywords
cervical epidural steroid injection, transforaminal approach, epidural catheter targeted, interlaminar approach, cervical radicular pain
Brief summary
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.
Interventions
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).
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
Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2
Sponsors
Study design
Masking description
Each subject will be randomized into a group assignment in a 1:1 manner, #1 or #2, as outlined in the Methods section
Intervention model description
Prospective, randomized, comparative trial
Eligibility
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score | 1 month follow up | The Percentage of Participants with Reduction of 50% or More of Neck and Arm Pain NRS score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neck Disability Index-5 | 1 month, 3 month, 6 month, and 1 year follow up | Percentage of patients with \>30% improvement in Neck Disability Index-5 score. |
| Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III | 1 month, 3 month, 6 month, and 1 year follow up | 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. |
| The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved) | 1 month, 3 month, 6 month, and 1 year follow up | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transforaminal ESI With Dexamethasone Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate
Transforaminal ESI with dexamethasone: 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).
Dexamethasone Sodium Phosphate 10 MG/ML: Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1
Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2 | 60 |
| Interlaminar Catheter-targeted ESI With Triamcinolone Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide
Transforaminal catheter-targeted ESI with triamcinolone: 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).
Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
Triamcinolone Acetonide 40mg/mL: Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2 | 57 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not receive allocated intervention. | 0 | 3 |
Baseline characteristics
| Characteristic | Interlaminar Catheter-targeted ESI With Triamcinolone | Total | Transforaminal ESI With Dexamethasone |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 18 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 99 Participants | 51 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 57 participants | 117 participants | 60 participants |
| Sex: Female, Male Female | 32 Participants | 66 Participants | 34 Participants |
| Sex: Female, Male Male | 25 Participants | 51 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 57 |
| other Total, other adverse events | 0 / 60 | 0 / 57 |
| serious Total, serious adverse events | 0 / 60 | 0 / 57 |
Outcome results
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
Population: \>50% Pain Reduction scored with 95% Confidence Interval.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transforaminal ESI With Dexamethasone | The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score | 49.1 percentage of participants |
| Interlaminar Catheter-targeted ESI With Triamcinolone | The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score | 68.5 percentage of participants |
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
Population: Analysis was done for different timelines of one month, three months, six months, and one year.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Transforaminal ESI With Dexamethasone | Neck Disability Index-5 | One month | 48 percentage of participants |
| Transforaminal ESI With Dexamethasone | Neck Disability Index-5 | Three month | 56 percentage of participants |
| Transforaminal ESI With Dexamethasone | Neck Disability Index-5 | Six month | 55 percentage of participants |
| Transforaminal ESI With Dexamethasone | Neck Disability Index-5 | One year | 47 percentage of participants |
| Interlaminar Catheter-targeted ESI With Triamcinolone | Neck Disability Index-5 | One year | 60 percentage of participants |
| Interlaminar Catheter-targeted ESI With Triamcinolone | Neck Disability Index-5 | One month | 62 percentage of participants |
| Interlaminar Catheter-targeted ESI With Triamcinolone | Neck Disability Index-5 | Six month | 56 percentage of participants |
| Interlaminar Catheter-targeted ESI With Triamcinolone | Neck Disability Index-5 | Three month | 58 percentage of participants |
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
Population: Analysis was done for different timelines of one month, three months, six months, and one year.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Transforaminal ESI With Dexamethasone | Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III | Three month | 20 percentage of participants |
| Transforaminal ESI With Dexamethasone | Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III | One month | 16 percentage of participants |
| Transforaminal ESI With Dexamethasone | Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III | Six month | 15 percentage of participants |
| Transforaminal ESI With Dexamethasone | Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III | One year | 7 percentage of participants |
| Interlaminar Catheter-targeted ESI With Triamcinolone | Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III | One year | 8 percentage of participants |
| Interlaminar Catheter-targeted ESI With Triamcinolone | Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III | One month | 19 percentage of participants |
| Interlaminar Catheter-targeted ESI With Triamcinolone | Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III | Three month | 17 percentage of participants |
| Interlaminar Catheter-targeted ESI With Triamcinolone | Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III | Six month | 19 percentage of participants |
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
Population: Analysis was done for different timelines of one month, three months, six months, and one year.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Transforaminal ESI With Dexamethasone | The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved) | One month | 41 percentage of participants |
| Transforaminal ESI With Dexamethasone | The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved) | Three months | 42 percentage of participants |
| Transforaminal ESI With Dexamethasone | The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved) | Six months | 55 percentage of participants |
| Transforaminal ESI With Dexamethasone | The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved) | One year | 57 percentage of participants |
| Interlaminar Catheter-targeted ESI With Triamcinolone | The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved) | One year | 61 percentage of participants |
| Interlaminar Catheter-targeted ESI With Triamcinolone | The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved) | One month | 59 percentage of participants |
| Interlaminar Catheter-targeted ESI With Triamcinolone | The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved) | Six months | 53 percentage of participants |
| Interlaminar Catheter-targeted ESI With Triamcinolone | The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved) | Three months | 57 percentage of participants |