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Treatment for Lumbar Radiculopathy

N/A
Waitlist Available
Led By Erica J Bial, M.D., M.S.
Research Sponsored by Lahey Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week post-op, 1 month post-op, 3 months post-op
Awards & highlights

Summary

This randomized control trial will compare opioid use, pain, and functional outcomes following decompression surgery for single-level lumbar radiculopathy in patients who undergo placement of corticosteroid epidural injection within 2 weeks prior to surgery compared to those who do not. The hypothesis of this study is that patients who receive the preoperative corticosteroid injection will have less reduced postoperative opioid use, as well as earlier mobilization, reduced length of stay, and faster return to work compared to control patients who do not receive the injection.

Eligible Conditions
  • Lumbar Radiculopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week post-op, 1 month post-op, 3 months post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week post-op, 1 month post-op, 3 months post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Opioid Use - conversion to oral morphine equivalents using standard table
Secondary outcome measures
Disability - Oswestry Disability Index (ODI)
Pain - Visual Analog Scale (VAS)
Quality of Life - EuroQol-5D
Other outcome measures
Cost Analysis - Health Resource Diary

Side effects data

From 2022 Phase 3 trial • 475 Patients • NCT03818737
26%
Procedural pain
25%
Arthralgia
18%
Joint swelling
12%
Joint stiffness
10%
Post procedural contusion
3%
Post procedural haematoma
1%
Migraine
1%
Angina pectoris
1%
Cholecystitis
1%
Acute myocardial infarction
1%
Nephrolithiasis
1%
Invasive ductal breast carcinoma
1%
Traumatic pneumothorax
1%
Hypertension urgency
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bone Marrow Derived MSCs
Adipose-derived MSCs
Umbilical Cord Tissue (UCT) MSCs
Corticosteroid Injection

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
Patients will receive a corticosteroid epidural injection within 2 weeks of their scheduled lumbar surgery
Group II: ControlActive Control1 Intervention
Patients will not receive a corticosteroid injection within 2 weeks of their scheduled lumbar surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Corticosteroid injection
2018
Completed Phase 4
~1410

Find a Location

Who is running the clinical trial?

Lahey ClinicLead Sponsor
72 Previous Clinical Trials
245,245 Total Patients Enrolled
Erica J Bial, M.D., M.S.Principal InvestigatorLahey Clinic
Robert G Whitmore, M.D.Principal InvestigatorLahey Clinic
~0 spots leftby Sep 2025
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