Small Needle Vertical Caudal Epidural Injection Method: Success Rate and Safety Profile

Abstract

Objective(s): To assess the efficacy of concurrent dextrose prolotherapy and physical therapy in reducing pain and reversing degenerative changes in participants with painful rotator cuff tendinopathy. Design: Randomized double-bind controlled trial. Setting: Outpatient pain medicine practice. Participants: Chronic shoulder pain and ultrasound-confirmed rotator cuff tendinopathy. Interventions: Delayed treatment control period, followed by concurrent physical therapy (six sessions) and three monthly solution-and-depthconcealed (participant, evaluator) or solution-concealed (injector) injections of normal saline/0.1% lidocaine either above (Superfic-Saline) or onto painful entheses (Enth-Saline), or onto entheses with 25% dextrose included (Enth-Dex). Main Outcome Measure(s): Primary: 0-10 Visual Analog Score (VAS) for pain, 0-10 Ultrasound Pathology Rating Scale (USPRS) and a 0-10 satisfaction score. Results: No baseline differences between groups in demographics or duration of delayed treatment control period (3.5 2.1months; pZ.920). The 74 participants had moderate to severe shoulder pain (7.0 2.0) for 7.6 9.6 years. Only 7 participants were both confident and correct about their group assignment with no difference between groups. Each group significantly outperformed their delayed treatment control at short term (3 month) followup. At 9 month follow-up 59 percent of Enth-Dex participants maintained a 2.8 improvement in VAS pain(twice the MCID) compared to Enth-Saline (35%;pZ.088) and Superfic-Saline (27%;pZ.017), and Enth-Dex participants’ satisfaction was 6.7 3.2 (10Z completely satisfied) compared to Enth-Saline (4.7 4.1;pZ.079) and Superfic-Saline (3.9 3.1;pZ.003) participants. USPRS findings were not different between groups (p Z .734). Conclusions: Concurrent physical therapy and dextrose prolotherapy resulted in superior long term pain improvement and satisfaction in chronically painful rotator cuff tendinopathy in comparison with physical therapy and a superficial saline control injection, with intermediate results for entheses injection with saline. These differences could not be attributed to a regenerative effect.