Epidural Steroids for Back Pain
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Hospital for Special Surgery, New York
Must not be taking: Opioids, Steroids
Disqualifiers: Chronic pain, Uncontrolled diabetes, Cancer, others
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial tests if applying a steroid during back surgery helps patients recover faster and need less pain medication. It focuses on patients having a specific type of back surgery and looks at their recovery and pain levels.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on chronic steroid therapy or immunosuppressants, you may not be eligible to participate.
What data supports the effectiveness of the drug Depo-Medrol 40Mg/Ml Suspension for Injection in treating back pain?
Research shows that patients receiving Depo-Medrol injections for low back pain reported significant pain and disability reduction after 4 weeks compared to those receiving another steroid, betamethasone. Additionally, Depo-Medrol was found to provide greater and earlier improvement in patients with chronic sciatica compared to another treatment.
12345Is it safe to use epidural steroids like Depo-Medrol for back pain?
Epidural steroid injections like Depo-Medrol are generally considered safe, with studies showing no side effects in patients treated for back pain. However, rare complications can occur, such as accidental injection into the wrong area, which can lead to serious issues like retinal detachment.
12367How does the drug used in epidural steroid injections for back pain differ from other treatments?
Epidural steroid injections, specifically using methylprednisolone (Depo-Medrol), are unique because they deliver the medication directly into the epidural space around the spinal cord, providing targeted anti-inflammatory effects. This method can offer significant pain relief and improved function, especially in the short term, compared to other steroids like betamethasone, which may not be as effective when administered epidurally.
12348Eligibility Criteria
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.Inclusion Criteria
I am scheduled for a surgery to remove part of one or two vertebrae.
I am between 18 and 85 years old.
Exclusion Criteria
Your diabetes is not well controlled, with an A1C level higher than 6.5.
You are allergic to Depo-Medrol, glucocorticoids, or other steroids.
You have used opioid medication daily in the past 6 months.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo 1-2 level lumbar laminectomy with either 40 mg Depo-Medrol or 1 mL of sterile normal saline applied to the surgical wound
During surgery
1 visit (in-person)
Post-operative Monitoring
Participants are assessed daily for two weeks post-operatively for opioid usage and other outcomes
2 weeks
Daily assessments (in-person or virtual)
Follow-up
Participants are monitored for safety and effectiveness, including pain and return to work, at 1 and 3 months post-operation
3 months
2 visits (in-person)
Participant Groups
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).
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1: Topical SteroidExperimental Treatment1 Intervention
Group II: Group 2: Topical Normal SalinePlacebo Group1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hospital for Special SurgeryNew York, NY
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Who Is Running the Clinical Trial?
Hospital for Special Surgery, New YorkLead Sponsor
References
Comparison of epidural Depo-Medrol vs. aqueous betamethasone in patients with low back pain. [2006]Despite the popularity of epidural steroid injections for low back pain, there still remains a lack of consensus on which type of steroid to inject. Most comparison studies regarding epidural steroids are based on an assumption that different types of steroids are equal as long as equipotent doses are utilized. In the spring of 2002, a national shortage of all depo steroids allowed the authors to compare epidural methylprednisolone (Depo-Medrol) to a non depo form of betamethasone in patients with low back pain. Patients who received epidural methylprednisolone (Depo-Medrol) reported significant reduction in pain ratings as well as disability scores after 4 weeks, while patients receiving betamethasone showed no significant difference in pain or disability scores. This study shows that the aqueous steroid betamethasone is not an effective alternative to the commonly used depo-steroid methylprednisolone (Depo-Medrol) when injected epidurally in patients with lumbar pain. The study also shows that the anti-inflammatory effect of a depo-steroid can be greater than a non-depo steroid, even at equipotent doses. This should be an important factor to consider when reviewing epidural steroid outcome studies, where the type of steroid might affect results as much as other variables such as route of administration, volume of injectate, or use of fluoroscopy.
Management of diskogenic pain using epidural and intrathecal steroids. [2019]The use of methylprednisolone acetate (Depo-Medrol) injected by the epidural or intrathecal route for the relief of diskogenic back pain with or without radiculopathy is an adjunct to conservative management useful when conservative measures fail and surgical treatment is under consideration. This is especially true when symptoms have been present for only a few months. Corticosteroids injected in the same manner seem to have little effect on patients with symptoms persisting for periods longer than 3 months or in patients treated previously by surgical methods.
[Epidural injections of steroids in the treatment of patients with chronic sciatica in discopathy]. [2018]The authors tried to assess the effectiveness of the treatment with epidural steroid injections in cases with lumbar discopathy and chronic ischialgia++. Thirty patients were given one or two injections of Depo-Medrol or Polcortolon with added bupivacaine++ into the epidural space. The same number of patients were treated without such injections. Control examinations after 21 days showed greater and earlier improvement after Depo-Medrol . The results of Polcortolon were less evident. No side effects were observed.
Epidural application of cortico-steroids in low-back pain and sciatica. [2019]Seven women and nine men, aged 27-59 years (mean 45), with lumbar pain and sciatica had epidural blocks once with 80 mg of depo-medrol and lidocaine in individual doses. All had static and kinetic lumbar pain up to 16 years and all but four also pain radiating to the lower limbs. Radiculography was "negative" in all patients, but three exhibited minor neurological abnormalities. Five patients had had a lumbar hemilaminectomy previously. In case of segmental pain in the lower limbs the appropriate level was used, in all other patients injection was done in L3-4 interspace. By means of a visual analogous scale 10 patients (62%) stated relief of half the pain the following day. One month later only 7 patients (43%) stated relief of one third of the pain. Only one patient benefited ultimately (after 6 months). In the remainder complaints were unaffected by the epidural injection. These discouraging results are not compatible with other reports, and a planned double-blind randomized investigation was abandoned. For the present category of patients (long-lasting complaints, previous "disc" operations) we found the epidural steroid injection useless.
Use of epidural corticosteroids in low back pain. [2017]To review the literature regarding the safety and efficacy of epidural corticosteroid injections in the treatment of low back pain (LBP) of various etiologies.
Complications associated with epidural steroid injections. [2022]Warnings about the hazards of epidural steroid injections occasionally appear in both medical and lay literature despite a lack of objective data to support such concerns. This literature review was undertaken to survey reports of adverse reactions associated with that procedure.
[Retinal detachment after accidental intra-vitreous Depo-Medrol injection. A case report]. [2018]Accidental Depo-Medrol injection into vitreous cavity is a very rare complication and early retinal detachment, associated with it, has a very poor prognosis.
Clinical and histological effects of the intrathecal administration of methylprednisolone in dogs. [2013]Methylprednisolone is one of the most commonly used steroids for management of chronic back pain via epidural injection. Its inadvertent injection into the intrathecal space is associated with complications such as adhesive arachnoiditis.