Preliminary results of a randomized, equivalence trial of fluoroscopic caudal epidural injections in managing chronic low back pain: Part 3 - Post surgery syndrome

Pain Management Center of Paducah, Paducah, KY 42003, USA.
Pain physician (Impact Factor: 3.54). 01/2008; 11(6):817-31.
Source: PubMed


Post surgery syndrome resulting in persistent pain following lumbar spine surgery is common. Speculated causes of post lumbar surgery syndrome include stenosis, degeneration of adjacent segments, internal disc disruption, recurrent disc herniation, retained disc fragment, epidural or intraneural fibrosis, radiculopathy, and various other causes. Epidural injections are most commonly used in post surgery syndrome. There is lack of evidence for the effectiveness of epidural injections in managing chronic low back pain with or without lower extremity pain secondary to post surgery syndrome.
A randomized, double-blind, equivalence trial.
An interventional pain management practice, a specialty referral center, a private practice setting in the United States.
To evaluate the effectiveness of caudal epidural injections in patients with chronic low back and lower extremity pain after surgical intervention with post lumbar surgery syndrome.
Patients were randomly assigned to one of 2 groups; Group I patients received caudal epidural injections with local anesthetic (lidocaine 0.5%), whereas Group II patients received caudal epidural injections with 0.5% lidocaine 9 mL mixed with 1 mL of 6 mg non-particulate Celestone. Randomization was performed by computer-generated random allocation sequence by simple randomization.
Multiple outcome measures were utilized which included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3 months, 6 months, and 12 months post-treatment. Significant pain relief was described as 50% or more, whereas significant improvement in the disability score was defined as a reduction of 40% or more.
Significant pain relief (> or =50%) was recorded in 60% to 70% of the patients with no significant differences noted with or without steroid over a period of one-year. In addition, functional assessment measured by the ODI also showed significant improvement with at least 40% reduction in Oswestry scores in 40% to 55% of the patients. The average procedures per year were 3.4 with an average total relief per year of 31.7 +/- 19.10 weeks in Group I and 26.2 +/- 18.34 weeks in Group II over a period of 52 weeks.
The results of this study are limited by the lack of a placebo group and the preliminary report size of only 20 patients in each group.
Caudal epidural injections in chronic function-limiting low back pain in post surgery syndrome without facet joint pain demonstrated effectiveness with over 55% of the patients showing improvement in functional status with significant pain relief in 60% to 70%.


Available from: Sukdeb Datta, Apr 17, 2015
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    • "Particularly, there are no studies evaluating the effectiveness of fluoroscopically directed caudal epidural injections under optimal conditions of contemporary interventional pain management practice in a large number of patients. Multiple studies have been criticized, most importantly for their design and their inability to confirm the location of the injectate by not using fluoroscopy 11,58,60,62,63,72-74. Multiple systematic reviews have been criticized for their methodology by evaluating studies inappropriately, thus, reaching inaccurate conclusions based on inappropriate evidence synthesis 11-13,44-64,71,75. "
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    ABSTRACT: Study Design: A randomized, active control, double-blind trial. Objective: To evaluate the effectiveness of fluoroscopically directed caudal epidural injections with or without steroids in managing chronic low back and lower extremity pain secondary to post lumbar surgery syndrome. Summary of Background Data: There is a paucity of evidence concerning caudal epidural injections for managing chronic persistent low back pain with or without lower extremity pain caused by post lumbar surgery syndrome. Methods: This active control randomized study included 140 patients with 70 patients in each group. Group I received 0.5% lidocaine, 10 mL; Group II received 9 mL of 0.5% lidocaine mixed with 1 mL of 6 mg of nonparticulate betamethasone. The multiple outcome measures included the numeric rating scale, the Oswestry Disability Index 2.0, employment status, and opioid intake with assessments at 3, 6, 12, 18, and 24 months posttreatment. Primary outcome was defined as at least 50% improvement in pain and Oswestry Disability Index scores. Patients with a positive response to the first 2 procedures with at least 3 weeks of relief were considered to be successful. All others were considered as failures. Results: Overall in Group I, 53% and 47% of the patients and in Group II, 59% and 58% of the patients, showed significant improvement with reduction in pain scores and disability index at 12 months and 24 months. In contrast, in the successful groups, significant pain relief and improvement in function were observed in 70% and 62% of Group I at one and 2 years; in 75% and 69% of Group II at one and 2 years. The results in the successful group showed that at the end of the first year patients experienced approximately 38 weeks of relief and at the end of 2 years Group I had 62 weeks and Group II had 68 weeks of relief. Overall total relief for 2 years was 48 weeks in Group I and 54 weeks in Group II. The average procedures in the successful groups were at 4 in one year and 6 at the end of 2 years. Conclusion: Caudal epidural injections of local anesthetic with or without steroid might be effective in patients with chronic persistent low back and/or lower extremity pain in patients with post lumbar surgery syndrome.
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