A randomized clinical trial of a tailored comprehensive care treatment program for temporomandibular disorders. Dysfunctional patients with temporomandibular disorders: evaluating the efficacy of a tailored treatment protocol. Brief group cognitive-behavioral intervention for temporomandibular disorders. A randomized clinical trial using research diagnostic criteria for temporomandibular disorders-axis II to target clinic cases for a tailored self-care TMD treatment program. Determining the effectiveness of a clinical-practice intervention in improving the control of pain in outpatients with cancer. Evidence-based postoperative pain management in nursing: is a randomized-controlled trial the most appropriate design? Short- and long-term efficacy of brief cognitive-behavioral therapy for patients with chronic temporomandibular disorder pain: a randomized, controlled trial. Developing a database of published reports of randomised clinical trials in pain research. Implementation of RCGP guidelines for acute low back pain: a cluster randomised controlled trial. Does systematic graded exposure in vivo enhance outcomes in multidisciplinary chronic pain management groups?
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. Forty-eight dysfunctional patients (i.e., high levels of pain, interference, and affective distress and low levels of perceived control) with temporomandibular disorders (TMDs) were randomly assigned either to a treatment consisting of an intraoral appliance (IA) and stress management with biofeedback (SM) plus nondirective, supportive counseling (SC) -- IA + SM + SC -- or to a customized treatment that included cognitive therapy (CT) with the IA and SM--IA + SM + CT. Both treatment groups reported statistically significant reductions on a set of physical, psychosocial, and behavioral measures posttreatment and at a 6-month follow-up. However, the intervention that included CT demonstrated significantly greater reductions in pain, depression, and medication use. Only the groups receiving the treatment that included the CT demonstrated continued improvements to the follow-up on pain associated with muscle palpation, self-reported pain severity, depression, and use of medications. These results support the efficacy of the tailored treatment for dysfunctional TMD. Temporomandibular disorders (TMD) are currently viewed as an interrelated set of clinical conditions presenting with signs and symptoms in masticatory and related muscles of the head and neck, and the soft tissue and bony components of the temporomandibular joint. Epidemiologic and clinical studies of TMD confirm its status as a chronic pain problem. In this report we present results from a randomized clinical trial which compared, at 3- and 12-month follow-ups, the effects of usual TMD treatment on TMD pain and related physical and psychological variables with the effects of a cognitive-behavioral (CB) intervention delivered to small groups of patients before usual TMD treatment began. The purpose of this study was to determine whether a minimal CB intervention followed by dental TMD treatment enhanced the effects of usual clinical dental treatment. A second purpose of the study was to determine whether patients classified as high in somatization and psychosocial dysfunction would respond less favorably to this minimal intervention than would those low in somatization and dysfunction. Patients who participated in the CB intervention followed by usual treatment showed greater long-term decreases in reported pain level and pain interference in daily activities than did patients who received only usual treatment. The benefits of CB intervention were not seen when the CB and UT groups were compared at 3-month follow-up. During the 3-12-month follow-up interval, however, the UT group maintained essentially the same level of improvement in characteristic pain while the CB group continued to improve, as hypothesized. During this same follow-up interval, the CB group also showed a strong trend toward continued improvement in pain interference. Such effects were not observed for depression, somatization, or clinical measures of jaw range of motion. Additionally, as hypothesized, dysfunctional chronic pain patients did not appear to benefit from the brief CB intervention. Intent to treat analyses were also performed to assess generalizability of the results. To carry out a randomized clinical trial (RCT) contrasting usual conservative treatment of TMD by clinical TMD specialists with a structured self-care intervention, targeted to clinic cases independent of TMD physical diagnosis, who were reporting minimal levels of psychosocial dysfunction; the intervention was delivered by dental hygienists in lieu of usual treatment.
                The Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) was used to target subjects who exhibited minimal TMD-related psychosocial interference. Criteria for study inclusion were: (1) self-report of facial and/or masticatory muscle pain discomfort for which usual care was prescribed by the clinic TMD specialist; (2) RDC/TMD Axis II graded scale of chronic pain (GCP) score of 0, I, or II-Low. (3) Age 18 to 70 years.
                On 1-year follow-up, while both groups showed improvement in all clinical and self-report categories measured, patients in the tailored self-care treatment program compared to usual TMD treatment showed significantly; (a) decreased TMD pain, (b) decreased pain-related interference in activity; (c) reduced number of masticatory muscles painful; (d) fewer additional visits for TMD treatment. Groups were comparable with regard to measures of vertical range of motion. The self-care program was associated with consistent, but non-statistically significant, trends towards lower levels of depression and somatization. Ability to cope with TMD, knowledge concerning TMD and patient satisfaction was significantly enhanced for the self-care group. No participating patients experienced physical or personal adverse effects during the 1-year post-treatment follow-up period.
                Use of RDC/TMD psychosocial assessment criteria can contribute to successful clinical decision-making for the management of TMD. To determine the effectiveness of a clinical-practice intervention in improving the control of pain in outpatients with cancer.
                Between July 5 and September 30, 1995, a randomized, controlled trial of 510 cancer outpatients and 13 oncologists was conducted at 23 clinics in Indiana. All the patients completed assessments of their pain, their pain regimens, and the degrees of relief received; they were surveyed again by mail four weeks after their clinic visits. The intervention group's clinical charts contained a summary of the completed pain scales; the oncologists who treated these patients were instructed to review the summary sheet prior to an evaluation. This summary was not available for the oncologists treating the patients in the control group. Each patient's pain management index (PMI) was calculated: the patient's pain medication level was rated on a scale of 0 to 3; the patients's pain level was rated on a scale of 0 to 3 and then subtracted from the first rating. A negative PMI was interpreted as representing insufficient treatment. Data were analyzed with several statistical tests.
                In all, only 320 patients who reported cancer-related pain were used in the analysis: 160 to 260 in the control group and 160 of 250 in the intervention group. The groups were similar with respect to demographics, cancer sites, and performance status. A significant difference (p = .0162) in the physicians' prescription patterns was found. In the control group, prescriptions for 86% of the patients did not change, with no decrease in analgesic prescriptions; for 14% of the patients analgesic prescriptions increased. In the intervention group, analgesic prescriptions changed for 25% of the patients, decreasing for 5% and increasing for 20%. A decrease in the incidence of pain described as more than life's usual aches and pains was found for the intervention group (p = .05). No significant difference was found between the groups for the patients undertreated for pain, as measured by PMIs.
                Although analgesic regimens were altered significantly when the physicians understood more about the patient's pain, cancer pain management remains a complex problem. Future studies should focus on the long-term systematic incorporation of simple pain-assessment tools into daily outpatient oncology practices as well as on innovative ways to address other aspects of managing cancer pain. 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. We evaluated the short- and long-term efficacy of a brief cognitive-behavioral therapy (CBT) for chronic temporomandibular disorder (TMD) pain in a randomized controlled trial. TMD clinic patients were assigned randomly to four sessions of either CBT (n=79) or an education/attention control condition (n=79). Participants completed outcome (pain, activity interference, jaw function, and depression) and process (pain beliefs, catastrophizing, and coping) measures before randomization, and 3 (post-treatment), 6, and 12 months later. As compared with the control group, the CBT group showed significantly greater improvement across the follow-ups on each outcome, belief, and catastrophizing measure (intent-to-treat analyses). The CBT group also showed a greater increase in use of relaxation techniques to cope with pain, but not in use of other coping strategies assessed. On the primary outcome measure, activity interference, the proportion of patients who reported no interference at 12 months was nearly three times higher in the CBT group (35%) than in the control group (13%) (P=0.004). In addition, more CBT than control group patients had clinically meaningful improvement in pain intensity (50% versus 29% showed > or =50% decrease, P=0.01), masticatory jaw function (P<0.001), and depression (P=0.016) at 12 months (intent-to-treat analyses). The two groups improved equivalently on a measure of TMD knowledge. A brief CBT intervention improves one-year clinical outcomes of TMD clinic patients and these effects appear to result from specific ingredients of the CBT. A database of randomised clinical trials (RCTs) in pain research published from 1950 to 1990 was created following an extensive literature search. By applying a refined MEDLINE search strategy from 1966 to 1990 and by hand-searching more than 1,000,000 pages of a total of 40 biomedical journals published during the period 1950-1990, more than 8000 RCTs were identified. The RCTs were published in more than 800 journals and over 85% appeared between 1976 and 1990. If the trend of the last 15 years persists, a total of more than 15 000 RCTs will be published in pain relief by the year 2000. A detailed description of methods to ensure efficient use of resources during the identification, retrieval and management of the information in pain relief and other fields is given. Emphasis is made on the importance of refining MEDLINE search strategies, on the use of volunteers to hand-search journals and on careful monitoring of each of the steps of the process. The potential uses of the database to guide clinical and research decisions are discussed. The Royal College of General Practitioners (RCGP) has produced guidelines for the management of acute low back pain in primary care.
                To investigate the impact on patient management of an educational strategy to promote these guidelines among general practitioners (GPs).
                Group randomised controlled trial, using the health centre as the unit of randomisation.
                Primary care teams in north-west England.
                Twenty-four health centres were randomly allocated to an intervention or control arm. Practices in the intervention arm were offered outreach visits to promote national guidelines on acute low back pain, as well as access to fast-track physiotherapy and to a triage service for patients with persistent symptoms.
                Twenty-four centres were randomised. Two thousand, one hundred and eighty-seven eligible patients presented with acute low back pain during the study period: 1049 in the intervention group and 1138 in the control group. There were no significant differences between study groups in the proportion of patients who were referred for X-ray, issued with a sickness certificate, prescribed opioids or muscle relaxants, or who were referred to secondary care, but significantly more patients in the intervention group were referred to physiotherapy or the back pain unit (difference in proportion = 12.2%, 95% confidence interval [CI] = 2.8% to 21.6%).
                The management of patients presenting with low back pain to primary care was mostly unchanged by an outreach educational strategy to promote greater adherence to RCGP guidelines among GPs. An increase in referral to physiotherapy or educational programmes followed the provision of a triage service. Graded exposure in vivo (GEXP) treatment has been successfully used to reduce levels of pain-related fear and disability in some chronic pain patients, but its effectiveness has not been evaluated in general clinical settings using group-design studies. The purpose of this study was to determine if the systematic incorporation of GEXP into a multidisciplinary chronic pain management group (PMG) treatment program would result in better treatment outcomes than usual PMG treatment.
                One hundred forty-three chronic pain patients who were assessed as suitable for an outpatient multidisciplinary chronic PMG program were randomly allocated to 3 experimental conditions; usual PMG, PMG incorporating systematic graded exposure, and wait-list control.
                The clinical outcomes of the 2 treatment conditions were not significantly different, suggesting that the systematic incorporation of GEXP into a multidisciplinary PMG program did not result in better treatment outcomes than usual PMG treatment. Both group treatment programs were associated with significant treatment effects when compared with the wait-list control on measures of pain intensity, fear of movement/(re)injury, pain self-efficacy, activity level, and depression. No treatment effects were found on self-report measures of pain disability or anxiety.
                The addition of systematic graded exposure into a multidisciplinary chronic pain management program did not result in better clinical outcomes than the usual group treatment program. The validity of GEXP to the broader population of chronic pain patients warrants further investigation.
There is insufficient evidence to support or not support the effectiveness of the reported drugs for the management of pain due to TMD. There is a need for high quality RCTs to derive evidence of the effectiveness of pharmacological interventions to treat pain associated with TMD.