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Epidural Steroids for Back Pain

Phase 3

Recruiting

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients scheduled to undergo 1 to 2 level laminectomy

Between the ages of 18-85

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 month

Awards & highlights

Study Summary

This trial will study whether giving patients epidural steroids during lumbar laminectomy surgery reduces post-operative pain and opioid use.

Who is the study for?

This trial is for adults aged 18-85 undergoing a specific back surgery called lumbar laminectomy. It's not for those who don't speak English, have had daily opioid use in the last six months, need additional spine procedures, have chronic pain conditions, uncontrolled diabetes (A1C > 6.5), weakened immune systems, prostate issues causing urinary problems or are allergic to Depo-Medrol and steroids.Check my eligibility

What is being tested?

The study tests if applying Depo-Medrol steroid directly to the spinal area during surgery can reduce post-surgery opioid use and improve recovery outcomes like hospital stay duration and return-to-work time compared to a placebo (no active medication).See study design

What are the potential side effects?

Potential side effects of Depo-Medrol may include increased blood sugar levels, risk of infection due to immune system suppression, mood swings, weight gain around the face or abdomen, insomnia and potential increase in blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a surgery to remove part of one or two vertebrae.

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I am between 18 and 85 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 month 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 consumption [Both Groups]

Opioid use total [Both Groups]

Secondary outcome measures

Medical Complications [Both Groups]

Numeric Rating Pain Scale [Both Groups]

Oswestry Low Back Pain Disability Questionnaire [Both Groups]

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 1: Topical SteroidExperimental Treatment1 Intervention

Group II: Group 2: Topical Normal SalinePlacebo Group1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor

243 Previous Clinical Trials

59,180 Total Patients Enrolled

6 Trials studying Postoperative Pain

333 Patients Enrolled for Postoperative Pain

Media Library

Depo-Medrol 40Mg/Ml Suspension for Injection Clinical Trial Eligibility Overview. Trial Name: NCT05058287 — Phase 3

Postoperative Pain Research Study Groups: Group 1: Topical Steroid, Group 2: Topical Normal Saline

Postoperative Pain Clinical Trial 2023: Depo-Medrol 40Mg/Ml Suspension for Injection Highlights & Side Effects. Trial Name: NCT05058287 — Phase 3

Depo-Medrol 40Mg/Ml Suspension for Injection 2023 Treatment Timeline for Medical Study. Trial Name: NCT05058287 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Will this research study take in patients that are octogenarians or younger?

"This trial is open to patients that are within the age range of 18 to 85 years old. Out of the 1,128 total studies, 128 are for patients below 18 years old and 928 are for patients that are over the age of 65."

Answered by AI

Are there any ineligibility requirements to participate in this research?

"Around 150 individuals will be accepted into this study that looks at postoperative pain. To be eligible, participants must be aged 18 to 85 and experience pain."

Answered by AI

Is Depo-Medrol 40Mg/Ml Suspension for Injection accepted by the FDA?

"There is some evidence to support the efficacy of Depo-Medrol 40Mg/Ml Suspension for Injection, as this is a Phase 3 trial. Furthermore, there have been multiple rounds of data supporting its safety, so it received a score of 3."

Answered by AI

Is Depo-Medrol 40Mg/Ml Suspension for Injection a new medication?

"Currently, there are 151 clinical trials studying the effects of Depo-Medrol 40Mg/Ml Suspension for Injection. Of these, 40 are in Phase 3. Duarte, California is home to several of these trials, but there are 6753 locations across the globe researching Depo-Medrol 40Mg/Ml Suspension for Injection."

Answered by AI

What condition does Depo-Medrol 40Mg/Ml Suspension for Injection usually alleviate?

"Depo-Medrol 40Mg/Ml Suspension for Injection is a medication used to treat ophthalmia, sympathetic. Additionally, this drug can help patients with scalp structure, temporal arteritis, and lupus erythematosus."

Answered by AI

Who else is applying?

What state do they live in?

New Jersey

What site did they apply to?

Hospital for Special Surgery

What portion of applicants met pre-screening criteria?

Met criteria

Did not meet criteria

Why did patients apply to this trial?

I've tried everything to control my pain. I have CHIARI MALFORMATION /SYRINGOMYELIA I JUST HAD MY 3RD DECOMPRESSION LAMINECTOMY ON JULY 5TH I SUFFER CHRONIC BACK PAIN IM PRESCRIBED STRONG OPIODS AN DREAM OF THE DAY I NO LONGER HAVE TO BE ON OPIODS I WANT SOME OF MY LIFE BACK AN ARE WILLING TO TRY ANYTHING TO HELP THAT HAPPEN.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

2021. "Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05058287.

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