Clinical Trial Evaluates Spinal Cord Burst Stimulation for Back Pain after Spine Surgery

According to studies, approximately 30% of the patients who undergo surgery for degenerative spine disease do not achieve the desired results. This residual or worsened pain after spinal surgery is notoriously difficult to treat.

Chronic back pain is a serious condition affecting millions of people worldwide. It can affect your ability to work, play with your kids, or even just enjoy a good night's sleep. For many people, lumbar spine surgery can be a solution to this problem, but some patients still experience pain after the surgery.

It is estimated that up to 50,000 patients currently undergo spinal cord stimulation treatment per year worldwide, and one of the most common indications is persistent radicular pain following lumbar spine surgery. While the use of spinal cord burst stimulation is increasing, rigorous clinical evidence of its efficacy is lacking.

Clinical Trial

A clinical trial has aimed to investigate the efficacy of spinal cord burst stimulation in patients with chronic radiculopathy after surgery for degenerative lumbar spine disorders.

The trial involved 50 patients who had chronic radicular pain after lumbar spine surgery. Radicular pain is a type of pain that radiates from the spine to other parts of the body, such as the legs or arms. The patients underwent two 3-month periods with spinal cord burst stimulation and two 3-month periods with placebo stimulation in a randomized order.

Spinal cord burst stimulation involves implanting electrodes near the spinal cord and using them to deliver electrical pulses to the nerves that transmit pain signals. This can help to interrupt the pain signals and reduce the amount of pain that a person experiences.

Results

At the end of the 12-month period, the researchers found that patients who received spinal cord burst stimulation did not have a significant reduction in disability compared to those who received placebo stimulation.

Disability was measured using a scale called the Oswestry Disability Index (ODI), which assesses a person's ability to perform everyday activities such as walking, standing, and sitting. The average changes in ODI score were -10.6 points for the burst stimulation periods and -9.3 points for the placebo stimulation periods. These differences between the two groups were not statistically significant.

The results of the clinical trial also suggested that patients in the spinal cord burst stimulation group did not have lower pain or better quality of life compared to those in the placebo group. Additionally, nine patients (18%) experienced adverse events, including 4 (8%) who required surgical revision of the implanted system.

Conclusion

In conclusion, chronic back pain can have a significant impact on a person's quality of life, and lumbar spine surgery may not always provide complete relief. The results of this clinical trial suggest that spinal cord burst stimulation may not be a promising treatment option for patients who experience chronic radicular pain after surgery.

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