Evidence-based postoperative pain management in nursing: is a randomized-controlled trial the most appropriate design? Extracorporeal shock wave therapy in the treatment of lateral epicondylitis : a randomized multicenter trial. A comparison of open and percutaneous techniques in the surgical treatment of tennis elbow. Radiofrequency microtenotomy: a promising method for treatment of recalcitrant lateral epicondylitis. Surgical versus non-surgical treatment of ligamentous injuries following dislocation of the elbow joint. A prospective randomized study.
There is an increasing drive to make nursing care evidence-based. High quality evidence from systematic reviews relevant to postoperative pain relief exists, yet pain after surgery remains poorly controlled for many patients. This study aimed to assess whether implementing evidence-based pain management improved postoperative pain outcomes. Pain on a 0-10 scale was the primary outcome and analgesic consumption a secondary outcome. A baseline audit was undertaken on four surgical wards to establish whether there was a need for the study. A randomized-controlled trial was then designed to assess the effects of implementing an evidence-based approach to postoperative pain management. The four wards were randomized to receive the intervention or act as a control. Outcomes were assessed 3 months after the intervention on both intervention and control wards. The intervention (implementation of an oral analgesic algorithm derived from systematic reviews) was then implemented on the control wards and outcomes reassessed after 3 months on the control wards. The intervention was designed using an evidence-based approach to effective implementation. Four interactive sessions covered: (1) detailed feedback of baseline data and discussion (utilizing audit and feedback), (2) why systematic reviews, analgesic league tables and choice of drugs to develop an analgesic algorithm (see Figure 1), (3) principles of evidence based health care (EBHC), including critical appraisal and (4) facilitation and change workshop. The findings revealed no significant differences in pain level or drug use between the intervention and control wards. However, the control wards also changed during the control period. Possible explanations for this are discussed. When looking at changes compared with baseline, both intervention and control wards increased their use of algorithm drugs and reduced use of non-algorithm drugs during the study. No effects were found on pain in the intervention wards. Pain ratings at rest since surgery, on movement since surgery and worst pain on movement were significantly reduced compared with baseline in the control wards. Although there are many pressures to utilize a randomized-controlled trial study design in the culture of evidence-based health care, there will be times, especially when implementing complex changes in practice that other types of design should be considered. On the basis of observational trials, numerous investigators have recommended extracorporeal shock wave therapy as an alternative treatment for chronic lateral epicondylitis of the elbow. However, there has been no evidence of its efficacy from well-designed randomized clinical trials. The objective of this study was to find out whether extracorporeal shock wave therapy in combination with local anesthesia was superior to placebo therapy in combination with local anesthesia.
                A randomized multicenter trial with a parallel-group design was conducted. Following administration of local anesthesia, either extracorporeal shock wave therapy with three treatments of 2000 pulses each and a positive energy flux density (ED+) of 0.07 to 0.09 mJ/mm (2) or placebo therapy was applied on an outpatient basis. Treatment allocation was blinded for patients and for observers. The primary end point was based on the rate of success, as determined with the Roles and Maudsley score and whether additional treatment was required, twelve weeks after the intervention. Crossover was possible after assessment of the primary end point. Secondary end points were the Roles and Maudsley score, subjective pain rating, and grip strength after six and twelve weeks and after twelve months. The planned number of 272 patients was included in the study.
                The primary end point could be assessed for 90.8% of the patients. The success rate was 25.8% in the group treated with extracorporeal shock wave therapy and 25.4% in the placebo group, a difference of 0.4% with a 95% confidence interval of -10.5% to 11.3%. Similarly, there was no relevant difference between groups with regard to the secondary end points. Improvement was observed in two-thirds of the patients from both groups twelve months after the intervention. Few side effects were reported.
                Extracorporeal shock wave therapy as applied in the present study was ineffective in the treatment of lateral epicondylitis. The previously reported success of this therapy appears to be attributable to inappropriate study designs. Different application protocols might improve clinical outcome. We recommend that extracorporeal shock wave therapy be applied only in high-quality clinical trials until it is proved to be effective. We conducted a prospective, randomised, controlled trial of 45 patients (47 elbows), with tennis elbow, who underwent either a formal open release or a percutaneous tenotomy. All patients had pre- and post-operative assessment using the Disability of Arm, Shoulder and Hand (DASH) scoring system. Both groups were followed up for a minimum of 12 months. Statistical analyses using the Mann-Whitney U test and repeated measured ANOVA showed significant improvements for patient satisfaction (p = 0.012), time to return to work (p = 0.0001), improvements in DASH score (p = 0.001) and improvement in sporting activities (p = 0.046) in the percutaneous group. Those patients undergoing a percutaneous release returned to work on average three weeks earlier and improved significantly more quickly than those undergoing an open procedure. The percutaneous procedure is a quicker and simpler procedure to undertake and produces significantly better results. Recalcitrant lateral epicondylitis (elbow tendinosis) is a common cause of elbow pain. There are many forms of treatment, none being superior.
                The main hypothesis tested in this study is that radiofrequency microtenotomy offers better results than the extensor tendon release and repair operation for elbow tendinosis, especially earlier recovery.
                Randomized controlled trial; Level of evidence, 1.
                Twenty-four patients were randomized into 2 treatment groups, extensor tendon release and repair, and microtenotomy. Dynamic infrared thermography (DIRT) was employed as an objective method to verify the diagnosis as well as to document the outcome 3 months after the surgical procedure.
                Visual analog scale pain scores in the microtenotomy but not in the release group decreased significantly after 3 weeks. There was no statistically significant difference in pain scores between the 2 groups at 3, 6, and 12 weeks, and at 10 to 18 months. At 12 weeks, grip strength had improved significantly in the microtenotomy but not in the release group. The functional score was significantly increased in both groups. The DIRT group showed significant differences in epicondyle skin temperature between diseased and normal elbows both pre- and postoperatively. Abnormal DIRT images correlated well with elevated pain scores.
                Radiofrequency microtenotomy provides a promising alternative to the release operation for elbow tendinosis. Dynamic infrared thermography provides a reliable, noninvasive, objective method for the diagnosis of elbow tendinosis, as well as for evaluation of the outcome following treatment. Thirty consecutive patients who had dislocation of the elbow without concomitant fracture and who were sixteen years old or more were examined under general anesthesia for stability of the joint at an average of four days after the injury. All of the elbows showed medial and sixteen showed both medial and lateral instability. The patients were then randomly assigned to undergo either non-surgical or surgical treatment of the ligamentous injuries. All of the surgically treated elbows showed complete rupture or avulsion of both the medial and lateral collateral ligaments, and in about half of these patients the muscle origins were found to be torn from the humeral epicondyles. At follow-up, both groups showed generally good results; the differences were not statistically significant. There was no evidence that the results of surgical repair of the ligaments were any better than those of non-surgical treatment.
Due to a small number of studies, large heterogeneity in interventions across trials, small sample sizes and poor reporting of outcomes, there was insufficient evidence to support or refute the effectiveness of surgery for lateral elbow pain. Further well-designed randomised controlled trials and development of standard outcome measures are needed.