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. Extracorporeal shock wave therapy without local anesthesia for chronic lateral epicondylitis. Extracorporeal shock-wave treatment for tennis elbow. A randomised double-blind study. Pragmatic randomised controlled trial of local corticosteroid injection and naproxen for treatment of lateral epicondylitis of elbow in primary care. Efficacy of diclofenac in lateral epicondylitis of the elbow also treated with immobilization. The University of Montreal Orthopaedic Research Group.
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. The use of extracorporeal shock wave therapy for the treatment of lateral epicondylitis is controversial. The purpose of this study was to evaluate the use of extracorporeal shock wave therapy without local anesthesia to treat chronic lateral epicondylitis.
                One hundred and fourteen patients with a minimum six-month history of lateral epicondylitis that was unresponsive to conventional therapy were randomized into double-blind active treatment and placebo groups. The protocol consisted of three weekly treatments of either low-dose shock wave therapy without anesthetic or a sham treatment. Patients had a physical examination, including provocation testing and dynamometry, at one, four, eight, and twelve weeks and at six and twelve months after treatment. Radiographs, laboratory studies, and electrocardiograms were also evaluated prior to participation and at twelve weeks. A visual analog scale was used to evaluate pain, and an upper extremity functional scale was used to assess function. Crossover to active treatment was initiated for nonresponsive patients who had received the placebo and met the inclusion criteria after twelve weeks.
                A total of 108 of the 114 randomized patients completed all treatments and the twelve weeks of follow-up required by the protocol. Sixty-one patients completed one year of follow-up, whereas thirty-four patients crossed over to receive active treatment. A significant difference (p = 0.001) in pain reduction was observed at twelve weeks in the intent-to-treat cohort, with an improvement in the pain score of at least 50% seen in 61% (thirty-four) of the fifty-six patients in the active treatment group who were treated according to protocol compared with 29% (seventeen) of the fifty-eight subjects in the placebo group. This improvement persisted in those followed to one year. Functional activity scores, activity-specific evaluation, and the overall impression of the disease state all showed significant improvement as well (p < 0.05). Crossover patients also showed significant improvement after twelve weeks of active treatment, with 56% (nineteen of thirty-four) achieving an improvement in the pain score of at least 50% (p < 0.0001).
                These results demonstrate that low-dose shock wave therapy without anesthetic is a safe and effective treatment for chronic lateral epicondylitis. The efficacy of extracorporeal shock-wave therapy for tennis elbow was investigated using a single fractionated dosage in a randomised, double-blind study. Outcomes were assessed using the Disabilities of Arm, Shoulder and Hand questionnaire, measurements of grip strength, levels of pain, analgesic usage and the rate of progression to surgery. Informed consent was obtained before patients were randomised to either the treatment or placebo group. In the final assessment, 74 patients (31 men and 43 women) with a mean age of 43.4 years (35 to 71), were included. None of the outcome measures showed a statistically significant difference between the treatment and control groups (p > 0.05). All patients improved significantly over time, regardless of treatment. Our study showed no evidence that extracorporeal shock-wave therapy for tennis elbow is better than placebo. To compare the clinical effectiveness of local corticosteroid injection, standard non-steroidal anti-inflammatory drugs, and simple analgesics for the early treatment of lateral epicondylitis in primary care.
                Multicentre pragmatic randomised controlled trial.
                23 general practices in North Staffordshire and South Cheshire.
                164 patients aged 18-70 years presenting with a new episode of lateral epicondylitis. Interventions: Local injection of 20 mg methylprednisolone plus lignocaine, naproxen 500 mg twice daily for two weeks, or placebo tablets. All participants received a standard advice sheet and co-codamol as required.
                Participants' global assessment of improvement (five point scale) at four weeks. Pain, function, and "main complaint" measured on 10 point Likert scales at 4 weeks, 6 months, and 12 months.
                Over 2 years, 53 subjects were randomised to injection, 53 to naproxen, and 58 to placebo. Prognostic variables were similar between groups at baseline. At 4 weeks, 48 patients (92%) in the injection group were completely better or improved compared with 30 (57%) in the naproxen group (P<0.001) and 28 (50%) in the placebo group (P<0.001). At 12 months, 43 patients (84%) in the injection group had pain scores </=3 compared with 45 (85%) in the naproxen group and 44 (82%) in the placebo group (P>0.05).
                Early local corticosteroid injection is effective for lateral epicondylitis. Outcome at one year was good in all groups, and effective early treatment does not seem to influence this. To evaluate the efficacy of an oral nonsteroidal anti-inflammatory drug in the treatment of lateral epicondylitis.
                Multicenter double-blind randomized controlled trial in which the following hypothesis was tested: whether diclofenac sodium provided a 20% or greater improvement over rest and cast immobilization in the response rate to treatment of lateral epicondylitis beyond and over rest in an experimental group compared with a control group after 4 weeks of treatment.
                Recruitment from urban general practices and referrals to 4 university hospitals.
                During a 1-year period, 206 subjects aged 18 to 60 years with lateral epicondylitis were recruited from the clientele treated by family physicians. Thirty subjects refused to participate and 47 presented with exclusion criteria, leaving 129 subjects who entered the study. One subject withdrew after 21 days.
                The experimental group was treated with a daily dose of diclofenac sodium (150 mg) for 28 days, while the control group received a placebo during the same period. In addition, both groups were immobilized in a cast for 14 days and were told not to perform repetitive movements of the involved limb for 21 days.
                Measuring instruments consisted of grip strength measurements with a squeeze dynamometer, a visual analog pain scale, a visual analog function scale, and an 8-item pain-free function index.
                A statistically and clinically significant reduction of pain was associated with treatment with diclofenac, but no clinically significant difference in grip strength or functional improvement could be detected between the 2 groups. Secondary effects (diarrhea and abdominal pain) were significantly more frequent in the diclofenac-treated group.
                Taking into account the limited improvement noted over rest and cast immobilization and the number of associated adverse events, it is difficult to recommend the use of diclofenac in the treatment of lateral epicondylitis at the dosage used in this study.
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.