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Comparative Trial Via Tranforaminal Approach Versus Epidural Catheter Via Interlaminar Approach

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03382821
Enrollment
120
Registered
2017-12-26
Start date
2017-09-15
Completion date
2020-08-19
Last updated
2022-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Radiculopathy

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

PROCEDURETransforaminal 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).

PROCEDURETransforaminal 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).

Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1

DRUGLidocaine

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

University of Utah
Lead SponsorOTHER
Epimed
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

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

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

MeasureTime frameDescription
The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score1 month follow upThe Percentage of Participants with Reduction of 50% or More of Neck and Arm Pain NRS score

Secondary

MeasureTime frameDescription
Neck Disability Index-51 month, 3 month, 6 month, and 1 year follow upPercentage of patients with \>30% improvement in Neck Disability Index-5 score.
Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III1 month, 3 month, 6 month, and 1 year follow upThe 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 upPatient 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

ArmCount
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
Total117

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDid not receive allocated intervention.03

Baseline characteristics

CharacteristicInterlaminar Catheter-targeted ESI With TriamcinoloneTotalTransforaminal ESI With Dexamethasone
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
9 Participants18 Participants9 Participants
Age, Categorical
Between 18 and 65 years
48 Participants99 Participants51 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
57 participants117 participants60 participants
Sex: Female, Male
Female
32 Participants66 Participants34 Participants
Sex: Female, Male
Male
25 Participants51 Participants26 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 600 / 57
other
Total, other adverse events
0 / 600 / 57
serious
Total, serious adverse events
0 / 600 / 57

Outcome results

Primary

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.

ArmMeasureValue (NUMBER)
Transforaminal ESI With DexamethasoneThe Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score49.1 percentage of participants
Interlaminar Catheter-targeted ESI With TriamcinoloneThe Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score68.5 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Transforaminal ESI With DexamethasoneNeck Disability Index-5One month48 percentage of participants
Transforaminal ESI With DexamethasoneNeck Disability Index-5Three month56 percentage of participants
Transforaminal ESI With DexamethasoneNeck Disability Index-5Six month55 percentage of participants
Transforaminal ESI With DexamethasoneNeck Disability Index-5One year47 percentage of participants
Interlaminar Catheter-targeted ESI With TriamcinoloneNeck Disability Index-5One year60 percentage of participants
Interlaminar Catheter-targeted ESI With TriamcinoloneNeck Disability Index-5One month62 percentage of participants
Interlaminar Catheter-targeted ESI With TriamcinoloneNeck Disability Index-5Six month56 percentage of participants
Interlaminar Catheter-targeted ESI With TriamcinoloneNeck Disability Index-5Three month58 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Transforaminal ESI With DexamethasonePercentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale IIIThree month20 percentage of participants
Transforaminal ESI With DexamethasonePercentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale IIIOne month16 percentage of participants
Transforaminal ESI With DexamethasonePercentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale IIISix month15 percentage of participants
Transforaminal ESI With DexamethasonePercentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale IIIOne year7 percentage of participants
Interlaminar Catheter-targeted ESI With TriamcinolonePercentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale IIIOne year8 percentage of participants
Interlaminar Catheter-targeted ESI With TriamcinolonePercentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale IIIOne month19 percentage of participants
Interlaminar Catheter-targeted ESI With TriamcinolonePercentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale IIIThree month17 percentage of participants
Interlaminar Catheter-targeted ESI With TriamcinolonePercentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale IIISix month19 percentage of participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Transforaminal ESI With DexamethasoneThe Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved)One month41 percentage of participants
Transforaminal ESI With DexamethasoneThe Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved)Three months42 percentage of participants
Transforaminal ESI With DexamethasoneThe Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved)Six months55 percentage of participants
Transforaminal ESI With DexamethasoneThe Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved)One year57 percentage of participants
Interlaminar Catheter-targeted ESI With TriamcinoloneThe Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved)One year61 percentage of participants
Interlaminar Catheter-targeted ESI With TriamcinoloneThe Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved)One month59 percentage of participants
Interlaminar Catheter-targeted ESI With TriamcinoloneThe Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved)Six months53 percentage of participants
Interlaminar Catheter-targeted ESI With TriamcinoloneThe Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved)Three months57 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026