Particulate vs. Nonparticulate Epidural Steroid Injections for Lumbar Foraminal Stenosis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03245671
• Date of registration: 07/08/2017
• Prospective Registration: Yes
• Primary sponsor: Hospital for Special Surgery, New York
• Public title: Particulate vs. Nonparticulate Epidural Steroid Injections for Lumbar Foraminal Stenosis
• Scientific title: Particulate vs. Nonparticulate Epidural Steroid Injections for the Treatment of Symptomatic Unilateral Lumbar Foraminal Stenosis: a Prospective Double-blinded Randomized Study
• Date of first enrolment: December 2017
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03245671
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 4

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- English speaking/reading adults age 18-90 years

- Patients with complaints of unilateral radicular lower extremity symptoms

- NRS pain score >= 5

- Pain symptoms for at least 1 month's duration

- Patients deemed appropriate for lumbar transforaminal epidural steroid injections by
treating spine specialist

- Targeted injection level for L4 or L5

- MRI of lumbosacral spine that demonstrates and confirms single-level neural
compression secondary to unilateral lumbosacral foraminal or subarticular stenosis
consistent with clinical history and findings

- Lumbar foraminal stenosis severity of grades 1, 2, and 3

Exclusion Criteria:

- Patients with multiple symptomatic levels

- Patients who are deemed not appropriate to undergo lumbar transforaminal epidural
steroid injections (e.g., allergy to local anesthetics, radiographic dye contrast,
patients with high bleeding tendency, pregnancy)

- Patients involved with litigation or worker's compensation cases

- Patients who are unable to answer the questionnaires and perform follow-up visits

- Patients who have active, concurrent painful diagnoses (e.g., hip osteoarthritis,
greater trochanteric pain syndrome, knee pain, peripheral vascular disease, or
peripheral neuropathy) that may confuse clinical picture and impact patients' rating
and perception of their low back and radicular symptoms

- Patients with other spinal pathologies confirmed on imaging that may explain patient's
pain

- Patients who have additional severe foraminal stenosis inferior to the symptomatic
level (e.g., symptomatic L4 foraminal stenosis with severe L5 foraminal stenosis) will
not have those levels injected

- Non-English speakers



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lumbar Spinal Stenosis

Intervention(s)

Drug: Decadron Phosphate, Injectable

Procedure: Epidural Steroid Injection

Drug: Kenalog Injectable Product

Primary Outcome(s)

Improvement in function (2 weeks post-injection) [Time Frame: 2 weeks post-injection]

Improvement in function (3 months post-injection) [Time Frame: 3 months post-injection]

Improvement in function (6 weeks post-injection) [Time Frame: 6 weeks post-injection]

Improvement in function (6 months post-injection) [Time Frame: 6 months post-injection]

Secondary Outcome(s)

Side effects [Time Frame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection]

Patient satisfaction with the procedure [Time Frame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection]

Medication use [Time Frame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection]

Quality of life [Time Frame: 2 weeks, 6 weeks, 3 months, and 6 months post-injection]

Secondary ID(s)

2016-0615

Source(s) of Monetary Support

Please refer to primary and secondary sponsors