Lumbosacral Radiculopathy Clinical Trial
Lumbosacral radiculopathy is one of the leading of cause of disability in the U.S. and
worldwide. Among recent reviews evaluating epidural steroid injections, some 1 but not all 2
concluded them to be effective in the long-term. In our own double-blind, placebo-controlled
study evaluating epidural etanercept, the results showed significant benefit in favor of the
etanercept group, but no subject was included with a duration of pain > 9 months, and the
results of this study have yet to be replicated.
Currently, epidural steroid injections are the most frequently performed procedures in pain
clinics across the U.S. However, epidural steroids may benefit only a select group of
patients. The literature on treating sciatica is notable for a lack of randomized
comparative studies involving various treatments. The objective of this project is to
conduct a 3-arm study to determine the efficacy of 1) transforaminal epidural
corticosteroids; and 2) transforaminal epidural etanercept, in patients with lumbosacral
radiculopathy.
This is a 3-arm multi-center, randomized, double-blind, placebo-controlled study comparing
two treatments with transforaminal epidural saline. Each group will receive a 2nd procedure
identical to the first 2 weeks after the initial procedure.
Seventy-eight study participants will be randomized via a computerized randomization system
using SPSS software in groups of 6 at each institution by a research nurse not involved in
patient care. There will be 26 patients in each of the 3 groups. A physician unaware of the
patient's treatment group will place 22-gauge needles in the relevant foramen under
fluoroscopic guidance as determined by patient's symptoms and MRI findings. Once correct
placement is confirmed by contrast injection, the blinded physician will leave the room and
another physician will inject the medication. In group I, this will be 60 mg of
depo-methylprednisolone. In group II, this will be 4 mg of etanercept reconstituted in 2 ml
of sterile water. In group III, this will be normal saline.
Two weeks after the initial procedure, an identical procedure to the first one will be done
by the same physician or his designate. In addition to the study medication, each patient in
each group will receive 0.5 ml of 0.5% bupivacaine local anesthetic for immediate pain
relief during both injections before the study drug is delivered. The efficacy of blinding
will be assessed by a disinterested observer unaware of the randomization results after the
second procedure before discharge. Follow-up visits will be conducted one, three and six
months after the second injection, for those subjects who continue to experience > 50% pain
relief.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05654428 -
Effects of Mackenzie Extension and William Flexion Exercises in Lumbo-sarcal Radiculopathy
|
N/A | |
Terminated |
NCT01267825 -
CT Guided Injection for Low Back Radiculopathy: A Randomized Clinical Trial
|
Phase 4 | |
Completed |
NCT02935608 -
Study to Evaluate the Efficacy and Safety of BIIB074 in Neuropathic Pain From Lumbosacral Radiculopathy
|
Phase 2 | |
Completed |
NCT03727100 -
Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults
|
Phase 3 | |
Terminated |
NCT02951377 -
Mechanical Diagnosis and Treatment and/or Steroid Injections for Lumbar Radiculopathy
|
Phase 1 | |
Completed |
NCT03776318 -
Long-Term Follow-up Safety of Clonidine Micropellets
|
||
Active, not recruiting |
NCT04238793 -
Single Ascending Doses Study of KLS-2031 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
|
Phase 1/Phase 2 | |
Terminated |
NCT05614648 -
Sciatica Epidural Radiculopathy Experimental New Interventional TherapY Clonidine Micropellet
|
Phase 3 | |
Completed |
NCT06058806 -
Effects of Multimodal Physical Therapy in Patients With Lumbosacral Radiculopathy
|
N/A | |
Enrolling by invitation |
NCT05613569 -
A Long-term, 3-Year, Follow-up Study for Patients Completing the KS-GIG-001-01 Study
|
||
Completed |
NCT01917825 -
A Study of the Pharmacokinetics, Safety, and Preliminary Efficacy of MDT-15 in Subjects With Lumbosacral Radiculopathy
|
Phase 2 | |
Recruiting |
NCT06167044 -
Effect of Thoracic Mobilization on Lumbar Radiculopathy
|
N/A | |
Completed |
NCT00826124 -
Does Magnetic Resonance Imaging (MRI) Improve Interventional Outcomes for Lumbosacral Radiculopathy?
|
N/A | |
Recruiting |
NCT06216288 -
Effect of Combined Lumbar Traction and Repetitive Back Extension Exercise on H-reflex in Lumbosacral Radiculopathy
|
N/A | |
Completed |
NCT04778592 -
Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain
|
Phase 2 | |
Recruiting |
NCT05711121 -
Caudal Versus S1 Transforaminal Epidural Steroid Injection for the Treatment of Unilateral S1 Radiculopathy
|
N/A | |
Terminated |
NCT03514277 -
A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief
|
Phase 4 | |
Completed |
NCT01655849 -
Phase 2 Efficacy Trial of Z160 in Lumbosacral Radiculopathy
|
Phase 2 | |
Terminated |
NCT01836770 -
Epidural Contrast Flow Patterns of TESI Using the Inferior-Anterior Position as the Final Needle Tip Position.
|
N/A | |
Completed |
NCT01561027 -
Crossover Study of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
|
Phase 2 |