Ibuprofen + Dexamethasone for Lower Back Pain

This trial tests the effectiveness of combining ibuprofen and dexamethasone (a corticosteroid) for individuals with sudden lower back pain that radiates pain or tingling to their legs. It compares this treatment to a placebo to determine which provides better pain relief. Participants will also receive a brief educational session on managing back pain. This trial suits individuals who have experienced less than two weeks of back pain affecting daily activities and have not had frequent back pain in the past three months. Participants should not have had a recent back injury and must be able to return home after their hospital visit. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment can benefit more patients.

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use pain medication daily or have chronic steroid use. It's best to discuss your specific medications with the trial team.

A previous study showed that common pain relievers like ibuprofen, known as NSAIDs (non-steroidal anti-inflammatory drugs), help reduce pain and disability in people with low back pain. The relief was modest but noticeable. Research also shows that combining ibuprofen with dexamethasone, a type of steroid, can be effective for short-term pain relief. However, some studies suggest that dexamethasone might lead to longer-lasting pain in certain cases.

Ibuprofen is well-known and generally safe when used as directed. Dexamethasone is also widely used but can sometimes cause side effects like increased blood sugar or mood changes. In this trial, both medications are given at standard doses and for a short time, which usually limits the risk of serious side effects.

Researchers are excited about combining ibuprofen with dexamethasone for lower back pain because this approach could offer faster and more effective relief than using ibuprofen alone. While ibuprofen is commonly used for its anti-inflammatory properties, adding dexamethasone, a powerful steroid, may enhance pain relief by further reducing inflammation quickly. Additionally, the treatment includes a 15-minute educational intervention, which could improve patient understanding and management of their condition, potentially leading to better outcomes. This combination aims to address pain and inflammation more comprehensively, offering a potentially superior alternative to standard care options like non-steroidal anti-inflammatory drugs (NSAIDs) alone.

In this trial, participants will receive either a combination of ibuprofen and dexamethasone or ibuprofen with a placebo, along with an educational intervention. Research has shown that using ibuprofen with dexamethasone can help manage lower back pain. For example, a study with 160 patients who underwent back surgery found that dexamethasone significantly reduced pain during movement compared to a placebo (a pill with no active medicine). Ibuprofen, a common pain reliever, has also been proven in several studies to reduce pain more effectively than a placebo. This combination targets both inflammation and pain, potentially offering better relief for sudden lower back pain than ibuprofen alone.¹²³⁶⁷