Efficacy of Caudal Epidural Steroid Injection with Targeted Indwelling Catheter and Manipulation in Managing Patients with Lumbar Disk Herniation and Radiculopathy: A Prospective, Randomized, Single-Blind Controlled Trial.

BACKGROUND: Lumbar disk herniation (LDH) is considered a common cause of lumbosacral radiculopathy. Epidural steroid injection is a common method to treat inflammation associated with low back-related leg pain. Spinal manipulations are widely used, and systematic reviews have also shown that these manipulations are more effective than placebos.

OBJECTIVE: Due to the absence of clinical evidence, we designed a prospective, randomized, single-blind controlled trial in patients with LDH with radiculopathy, aiming to detect the safety and clinical efficacy of targeted indwelling catheter combined with "4-step" manipulative therapy in patients with LDH.

METHODS: Patient visits were performed at baseline and days 1, 3, 7, and 28 after treatment. Clinical outcomes were measured using visual analog scale for back and leg pain, Oswestry Disability Index (ODI), and clinical symptom scores of the Japanese Orthopedic Association (JAO).

RESULTS: The study included 85 eligible patients. They were categorized with a randomization schedule into a Catheter Group (N = 43) and No-Catheter Group (N = 42). Between the measurement points, there was a statistically significant difference in the visual analog scale (back) at days 1, 3, and 7 of follow-up after treatment between the 2 groups. The change was statistically different at days 1 and 3, and a higher change was observed in the Catheter Group compared with the No-Catheter Group. There was a statistically significant difference in change of JOA and ODI scores at day 1 of follow-up after treatment between the 2 groups, and a greater change was seen in the Catheter Group at days 1 and 3 compared with the No-Catheter Group.

LIMITATIONS: The small sample size was small, and the follow-up time was short. The study also lacked documents of adjuvant therapies, like individual patient exercise routines and analgesic drug therapy.

CONCLUSION: Both methods were effective in reducing pain intensity and functional disability compared with pretreatment. The Catheter Group showed a more significant decrease in visual analog scale and greater changes in JOA and ODI scores of short/term follow-up, compared with the No-Catheter Group. The therapy project was safe.