Randomized effectiveness study of four therapeutic strategies for TMJ closed lock. A prospective randomized controlled trial of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer. Efficacy of temporomandibular joint arthrocentesis with and without injection of sodium hyaluronate in treatment of internal derangements. A behavioral intervention to improve obstetrical care. A pilot study of health education via a nurse-run telephone self-management programme for elderly people with osteoarthritis. Effectiveness of continuous passive motion and conventional physical therapy after total knee arthroplasty: a randomized clinical trial. A randomized clinical trial of a tailored comprehensive care treatment program for temporomandibular disorders. Evidence-based postoperative pain management in nursing: is a randomized-controlled trial the most appropriate design? Randomized clinical trial assessing the effect of Doppler-optimized fluid management on outcome after elective colorectal resection.
For individuals with temporomandibular joint (TMJ) disc displacement without reduction with limited mouth opening (closed lock), interventions vary from minimal treatment to surgery. In a single-blind trial, 106 individuals with TMJ closed lock were randomized among medical management, rehabilitation, arthroscopic surgery with post-operative rehabilitation, or arthroplasty with post-operative rehabilitation. Evaluations at baseline, 3, 6, 12, 18, 24, and 60 months used the Craniomandibular Index (CMI) and Symptom Severity Index (SSI) for jaw function and TMJ pain respectively. Using an intention-to-treat analysis, we observed no between-group difference at any follow-up for CMI (p > or = 0.33) or SSI (p > or = 0.08). Both outcomes showed within-group improvement (p < 0.0001) for all groups. The findings of this study suggest that primary treatment for individuals with TMJ closed lock should consist of medical management or rehabilitation. The use of this approach will avoid unnecessary surgical procedures. A prospective randomized controlled trial (RCT) of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer.
                This study evaluates the use of a multimodal package in colorectal cancer surgery in the context of an RCT.
                Patients for elective resection for colorectal cancer were offered trial entry. Participants were stratified by sex and requirement for a total mesorectal excision and centrally randomized. Multimodal patients received intravenous fluid restriction, unrestricted oral intake with prokinetic agents, early ambulation, and fixed regimen epidural analgesia. Control patients received intravenous fluids to prevent oliguria, restricted oral intake until return of bowel motility, and weaning regimen epidural analgesia. Adherence to both regimens was reinforced using a daily checklist and protocol guidance sheets. Discharge decision was made using pre-agreed criteria. The primary endpoint was postoperative stay, and achievement of independence milestones. Secondary endpoints were postoperative complications, readmission rates, and mortality. Analysis was by intention to treat.
                Seventy patients were recruited. Approximately one fourth underwent TME. Median ages were similar (69.3 vs. 73.0 years). The median stay was significantly reduced in the multimodal group (5 vs. 7 days; P < 0.001, Mann-Whitney U test). Patients in the control arm were 2.5 times as likely to require a postoperative stay of more than 5 days. Patients in the multimodal group had less cardiorespiratory and anastomotic complications but more readmissions. There were 2 deaths, both controls.
                This RCT provides level 1b evidence that a multimodal management protocol can significantly reduce postoperative stay following colorectal cancer surgery. Morbidity and mortality are not increased. This study was designed to investigate the efficacy of arthrocentesis with and without injection of sodium hyaluronate (SH) into the upper joint space in the treatment of temporomandibular joint (TMJ) internal derangements.
                Forty-one TMJs in 5 males and 26 females aged 14 to 53 years comprised the study material. The patients' complaints were limited mouth opening, TMJ pain and tenderness, and joint noises during function. Patients were randomly divided into 2 groups in which only arthrocentesis was performed in 1 group and arthrocentesis plus intra-articular injection of sodium hyaluronate was performed in the other group. Both groups contained patients with disc displacement with reduction and with closed lock. Clinical evaluation of the patients was done before the procedure, immediately after the procedure, on postoperative day 1, and at 1, 2, 3, 4, 5, 6, 9, 12, 18, and 24 months postoperatively. Intensity of TMJ pain, jaw function, and clicking sounds in the TMJ were assessed using visual analog scales. Maximal mouth opening and lateral jaw movements also were recorded at each follow-up visit.
                Both techniques increased maximal mouth opening, lateral movements, and function, while reducing TMJ pain and noise.
                Although patients benefitted from both techniques, arthrocentesis with injection of SH seemed to be superior to arthrocentesis alone.
                Copyright 2001 American Association of Oral and Maxillofacial Surgeons. Implementation of evidence-based obstetrical practices remains a significant challenge. Effective strategies to disseminate and implement such practices are needed.
                We randomly assigned 19 hospitals in Argentina and Uruguay to receive a multifaceted behavioral intervention (including selection of opinion leaders, interactive workshops, training of manual skills, one-on-one academic detailing visits with hospital birth attendants, reminders, and feedback) to develop and implement guidelines for the use of episiotomy and management of the third stage of labor or to receive no intervention. The primary outcomes were the rates of prophylactic use of oxytocin during the third stage of labor and of episiotomy. The main secondary outcomes were postpartum hemorrhage and birth attendants' readiness to change their behavior with regard to episiotomies and management of the third stage of labor. The outcomes were measured at baseline, at the end of the 18-month intervention, and 12 months after the end of the intervention.
                The rate of use of prophylactic oxytocin increased from 2.1% at baseline to 83.6% after the end of the intervention at hospitals that received the intervention and from 2.6% to 12.3% at control hospitals (P=0.01 for the difference in changes). The rate of use of episiotomy decreased from 41.1% to 29.9% at hospitals receiving the intervention but remained stable at control hospitals, with preintervention and postintervention values of 43.5% and 44.5%, respectively (P<0.001 for the difference in changes). The intervention was also associated with reductions in the rate of postpartum hemorrhage of 500 ml or more (relative rate reduction, 45%; 95% confidence interval [CI], 9 to 71) and of 1000 ml or more (relative rate reduction, 70%; 95% CI, 16 to 78). Birth attendants' readiness to change also increased in the hospitals receiving the intervention. The effects on the use of episiotomy and prophylactic oxytocin were sustained 12 months after the end of the intervention.
                A multifaceted behavioral intervention increased the prophylactic use of oxytocin during the third stage of labor and reduced the use of episiotomy. (ClinicalTrials.gov number, NCT00070720 [ClinicalTrials.gov]; Current Controlled Trials number, ISRCTN82417627 [controlled-trials.com].).
                Copyright 2008 Massachusetts Medical Society. We conducted a pilot study of a nurse-run telephone self-management programme for elderly people with osteoarthritis (OA). Thirty-two subjects, aged 60 years or more, with a diagnosis of OA were recruited from two hospital rheumatology clinics and were randomized to a control or intervention group. The intervention group received six weekly mailings of OA health education modules, a relaxation audio-tape and six weekly 45 min follow-up telephone self-management sessions. There was a 100% compliance rate in the intervention group, and all subjects completed baseline and three-month interviews; one subject in each group was lost to six-month follow-up. There were no significant differences in self-management between the control and intervention groups. However, at three months there were improvements in the intervention group (relative to baseline) on some outcome measures. The results suggest that the telephone may be a useful tool for reinforcing health-promoting activities for patients. This randomized clinical trial was conducted to compare the effectiveness of 3 in-hospital rehabilitation programs with and without continuous passive motion (CPM) for range of motion (ROM) in knee flexion and knee extension, functional ability, and length of stay after primary total knee arthroplasty (TKA).
                Eighty-one subjects who underwent TKA for a diagnosis of osteoarthritis were recruited.
                All subjects were randomly assigned to 1 of 3 groups immediately after TKA: a control group, which received conventional physical therapy intervention only; experimental group 1, which received conventional physical therapy and 35 minutes of CPM applications daily; and experimental group 2, which received conventional physical therapy and 2 hours of CPM applications daily. All subjects were evaluated once before TKA and at discharge. The primary outcome measure was active ROM in knee flexion at discharge. Active ROM in knee extension, Timed "Up & Go" Test results, Western Ontario and McMaster Universities Osteoarthritis Index questionnaire scores, and length of stay were the secondary outcome measures.
                The characteristics of and outcome measurements for the subjects in the 3 groups were similar at baseline. No significant difference among the 3 groups was demonstrated in primary or secondary outcomes at discharge.
                The results of this study do not support the addition of CPM applications to conventional physical therapy in rehabilitation programs after primary TKA, as applied in this clinical trial, because they did not further reduce knee impairments or disability or reduce the length of the hospital stay. To test the usefulness of tailoring cognitive-behavioral therapy (CBT) for patients with temporomandibular disorders (TMD) who demonstrated poor psychosocial adaptation to their TMD condition, independent of physical diagnosis.
                A randomized clinical trial compared a 6-session CBT intervention delivered in conjunction with the usual TMD treatment to the usual conservative treatment by TMD specialist dentists. For study inclusion, Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), Axis II criteria, were used to target patients with elevated levels of TMD pain-related interference with daily activities, independent of physical diagnosis (i.e., Axis I).
                At the post-treatment assessment, about 4 months after the baseline evaluations, the comprehensive care group, when compared to the usual treatment group, showed significantly lower levels of characteristic pain intensity, significantly higher self-reported ability to control their TMD pain, and a strong trend (P = .07) toward lower pain-related interference in daily activities. From post-intervention to 1-year follow-up, all subjects showed improvement. At the 1-year follow-up, the comprehensive care group, while not losing any of its early gains, was not significantly different from the usual care group with regard to reported levels of pain, ability to control pain, and levels of interference in activities. For many of these psychosocially disabled TMD patients, pain and interference 1 year after treatment remained at the same or higher levels than those observed at baseline among a group of patients selected for a separate randomized clinical trial on the basis of better psychosocial adaptation.
                The 6-session CBT intervention for patients with heightened psychologic and psychosocial disability was effective in improving pain-related variables over the course of the CBT in conjunction with usual treatment, but was too brief an intervention to result in further improvement after the sessions ended. Patient ratings of treatment satisfaction and helfulness were high for both groups, but they were significantly higher for the comprehensive care 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. Protocolized fluid administration using oesophageal Doppler monitoring may improve the postoperative outcome in patients undergoing surgery.
                A total of 108 patients undergoing elective colorectal resection were recruited into a double-blind prospective randomized controlled trial. An oesophageal Doppler probe was placed in all patients. The control group received perioperative fluid at the discretion of the anaesthetist, whereas the intervention group received additional colloid boluses based on Doppler assessment. Primary outcome was length of postoperative hospital stay. Secondary outcomes were morbidity, return of gastrointestinal function and cytokine markers of the systemic inflammatory response. Standard preoperative and postoperative management was used in all patients.
                Demographic and surgical details were similar in the two groups. Aortic flow time, stroke volume, cardiac output and cardiac index during the intraoperative period were higher in the intervention group (P<0.050). The intervention group had a reduced postoperative hospital stay (7 versus 9 days in the control group; P=0.005), fewer intermediate or major postoperative complications (2 versus 15 percent; P=0.043) and tolerated diet earlier (2 versus 4 days; P=0.029). There was a reduced rise in perioperative level of the cytokine interleukin 6 in the intervention group (P=0.039).
                A protocol-based fluid optimization programme using intraoperative oesophageal Doppler monitoring leads to a shorter hospital stay and decreased morbidity in patients undergoing elective colorectal resection.
                Copyright (c) 2006 British Journal of Surgery Society Ltd.
In view of the paucity of high level evidence for the effectiveness of interventions for the management of TMJ OA, small parallel group RCTs which include participants with a clear diagnosis of TMJ OA should be encouraged and especially studies evaluating some of the possible surgical interventions.