Elsevier

World Neurosurgery

Volume 114, June 2018, Pages e29-e34
World Neurosurgery

Original Article
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

https://doi.org/10.1016/j.wneu.2018.01.162Get rights and content

Highlights

  • 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.

  • 85 eligible patients were categorized with a randomization schedule into the Catheter Group and No-Catheter Group.

  • The Catheter Group showed more significant decrease in VAS and greater changes in JOA and ODI scores of short/term follow-up, compared with the No-Catheter group.

  • The therapy project was safe.

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.

Section snippets

Background

Lumbosacral radiculopathy, developing from compression of ≥1 spinal nerve roots, is characterized by radiating leg pain, leg paresthesia, and neurologic impairment.1 Lumbar disk herniation (LDH), defined as localized disk displacement beyond the margins of the intervertebral disk space, is considered a common cause of lumbosacral radiculopathy.2, 3, 4, 5

Conservative interventions include advice, medication, traction, manipulation, stabilization exercise, physical therapy, laser, ultrasound, and

Study Design

The study was a prospective, randomized, single-blind, controlled trial. The study was conducted in accordance with the principles of the Declaration of Helsinki.13 Approval to perform the study was obtained from the ethics committee. Each participating center has obtained Institutional Review Board approval. All the participants signed informed consents before the study.

Inclusion Criteria

Inclusion criteria included 1) patients aged 18–70 years, 2) complaints of radiating leg pain, 3) correlative imaging

Patient Demographic and Clinical Characteristics

Database records of patients treated in our institution for symptomatic lumbar disk herniation between April 2016 and March 2017 were prospectively collected and analyzed. Of the 88 eligible patients, 3 did not fulfill the inclusion criteria. The remaining 85 eligible patients and their 4 weeks' follow-up at our institute were included in the study. They were categorized with a randomization schedule into the Catheter Group (43 patients, 50.6%) and No-Catheter Group (42 patients, 49.4%),

Discussion

Transforaminal ESI, also known as “nerve block,” places a needle alongside the nerve as it exits from the spine and injects medication into the “nerve sleeve.” The medication then travels up the sleeve and into the epidural space from the side. Transforaminal ESI can be modified better recovery. Caudal approach ESI, often referred as “epidural injection,” places the needle into the epidural space through the sacral hiatus, dispersing the steroid to a wider area. With the caudal approach, the

Conclusion

We conducted a prospective, randomized, single-blind controlled trial to assess the efficacy of caudal ESI with a targeted indwelling catheter combined with “4-step” manipulative therapy for patients with LDH. Both methods were effective in reducing pain intensity (VAS) and functional disability (JOA and ODI scores) compared with pretreatment. And the Catheter Group showed more significant decrease in VAS (back and leg) and greater changes in JOA and ODI scores of short/term follow-up, compared

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Conflict of interest statement: The authors received the following funding support: development of Chinese medicine in Shanghai 3-year action plan (2014–2016): Shanghai TCM clinical research base construction ZY3-LCPT-1-1003; construction of famous traditional Chinese medicine doctor “Mo Wen” and workshop in Pudong New Area PDZYXK-3-2014018; Natural Science Foundation of China (81403419); Clinical Research Plan of SHDC (16CR4011A, 16CR3074B,12012205); Shanghai Municipal Commission of Health and Family Planning (20164Y0081); Science and Technology Committee of Shanghai(17401934400, 16401930600).

Mengchen Yin, Wen Mo, Haiyang Wu, Jinhai Xu, and Jie Ye contributed equally to this work and should be considered as equal first authors.

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