Comparative Analysis of Early and Long-Term Outcomes of Patients with Degenerative Lumbar Spine Disease Using the DIAM Stabilizer and Standard Rehabilitation Program: A Preliminary Prospective Randomized Controlled Trial with 1-Year Follow-Up

Abstract

Low back pain (LBP) is a leading cause of disability and work absenteeism. The cause of LBP may be degeneration of the intervertebral disc. LBP is characterized by considerable variability and tends to develop into chronic pain. Treatment of LBP includes conservative and rehabilitative treatments, surgery, and so-called minimally invasive treatment. One of the most commonly performed procedures is interspinous stabilization using a dynamic interspinous DIAM (device for intervertebral assisted motion) stabilizer. There is still no clear, strong evidence for the effectiveness and superiority of surgical treatment over conservative treatment. This study aimed to compare the early and long-term outcomes of patients with LBP using the DIAM interspinous stabilizer in relation to patients treated conservatively. A group of 86 patients was prospectively randomized into two comparison groups: A (n = 43), treated with the DIAM dynamic stabilizer for degenerative lumbar spine disease (mean age = 43.4 years ± SD = 10.8 years), and B (n = 43), treated conservatively. Pain severity was assessed using the visual analog scale (VAS), whereas disability was assessed using the Oswestry disability index (ODI). The difference in preoperative and postoperative ODI scores ≥ 15 points was used as a criterion for treatment effectiveness, and the difference in VAS scores ≥ 1 point was used as a criterion for pain reduction. In patients under general anesthesia, the procedure only included implantation of the DIAM system. Patients in the control group underwent conservative treatment, which included rehabilitation, a bed regimen, analgesic drug treatment and periarticular spinal injections of anti-inflammatory drugs. It was found that all patients (n = 43) continued to experience LBP after DIAM implantation (mean VAS score of 4.2). Of the 36 patients who experienced LBP with sciatica before the procedure, 80.5% (n = 29) experienced a reduction in pain. As for the level of fitness, the average ODI score was 19.3 ± 10.3 points. As for the difference in ODI scores in the pre-treatment results vs. after treatment, the average score was 9.1 ± 10.6. None of the patients required reoperation at 12 months after surgery. There were no statistically significant differences between the two groups in either early (p = 0.45) or long-term outcomes (p = 0.37). In conclusion, neurosurgical treatment with the DIAM interspinous stabilizer was as effective as conservative treatment and rehabilitation during the one-year follow-up period.