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. Efficacy of splinting and oral steroids in the treatment of carpal tunnel syndrome: a prospective randomized clinical and electrophysiological study. Evaluation of occlusal splint therapy and relaxation procedures in patients with temporomandibular disorders. Short- and long-term efficacy of brief cognitive-behavioral therapy for patients with chronic temporomandibular disorder pain: a randomized, controlled trial. Comparison of ultrasound and ketoprofen phonophoresis in the treatment of carpal tunnel syndrome. 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. Brief group cognitive-behavioral intervention for temporomandibular disorders. The comparison of ultrasound treatment and local steroid injection plus splinting in the carpal tunnel syndrome: a randomized controlled trial. A randomized sham-controlled trial of a neurodynamic technique in the treatment of carpal tunnel syndrome. Two exercise interventions for the management of patients with ankylosing spondylitis: a randomized controlled trial. The subacromial impingement syndrome. A study of results of treatment with special emphasis on predictive factors and pain-generating mechanisms.
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. To study the efficacy of splinting and oral steroids in the management of carpal tunnel syndrome (CTS).
                Prospective, randomized, open-label, clinical and electrophysiological study with 3-month follow-up.
                Forty patients with CTS were randomly divided into splint group (N-20), wearing splint in neutral position for 4 weeks; and steroid group (N-20), who received oral prednisolone 20 mg/day for 2 weeks followed by 10 mg/day for 2 weeks. Clinical and electrophysiological evaluations were done at baseline and at 1-month and 3-month follow-up. Independent 't' test and paired 't' test were used for statistical analysis.
                Primary outcome measure was the symptom severity score and functional status score. Secondary outcome measures were median nerve sensory and motor distal latency and conduction velocity.
                At the end of 3 months, statistically significant improvement was seen in symptom severity score and functional status score in both groups (P<0.001). Median nerve sensory distal latency and conduction velocity also improved significantly in both the groups at 3 months. Improvement in motor distal latency was significant (P=0.001) at 3 months in steroid group, while insignificant improvement (P=0.139) was observed in splint group. On comparing the clinical and electrophysiological improvement between the two groups, except for the functional status score, there was no significant difference at 3-month follow-up. Improvement in functional status score was significantly more in steroid group (P=0.03).
                There was significant improvement in both groups, clinically as well as electrophysiologically, at 3 months. On comparing the efficacy of the two treatment methods, except for the functional status score, there was no significant difference between the two groups. Twenty-four patients were selected to participate in this study. Twelve patients were randomly selected to receive occlusal splint therapy and the other 12 to receive a simplified relaxation therapy technique. Observable pain scores, maximum comfortable interincisal distance, and maximum interincisal distances were recorded for each group before and after treatment. The occlusal splint group showed a significant decrease in total mean observable pain scores (decrease score of 10.5, t = 3.124; P less than 0.1). The relaxation group showed no significant decrease in total mean observable pain scores (decrease score of 1.8, t = 0.888; P = ns). The occlusal splint group showed a significant increase in the mean maximum comfortable opening (an increase of 12.4 mm, t = 5.085; P less than .01). The relaxation group showed no significant increase in the mean maximum comfortable opening (an increase of 2.3 mm, t = 0.734; P = ns). The occlusal splint group showed a significant increase in the mean maximum opening (an increase of 6.0 mm, t = 2.471; P less than .05). The relaxation group showed no increase in the mean maximum opening (decrease of 0.7 mm, t = 0.343; P = ns). This study suggests that occlusal splint therapy is a more effective treatment for the pain, tenderness, and limited mandibular opening associated with temporomandibular disorders than relaxation therapy. In this study, the relaxation technique used had no significant effect on the patients' pain, tenderness, or limited opening. 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. The aim of this study was to compare the efficacy of ultrasound (US) and ketoprofen phonophoresis (PH) in the treatment of carpal tunnel syndrome (CTS).
                This study was a prospective, randomised, controlled, double-blinded clinical trial with follow-up at 8 weeks. Fiftyone patients (76 median nerves) with clinical and electrophysiologic evidence of mild or moderate CTS were included in the study. They were randomly assigned to one of three groups; group 1 received sham US and splinting, group 2 received US and splinting, and group 3 received ketoprofen phonophoresis and splinting. Patients were evaluated by use of electrophysiological variables such as median motor distal latency (mMDL), median sensory distal latency (mSDL), functional status scale (FSS), symptom severity scale (SSS) and visual analog scale (VAS). Electrophysiological variables and scales were evaluated at the beginning, end of therapy (2nd week) and 8th week.
                All the randomised patients were included in the intention-to-treat (ITT) analysis. The per protocol (PP) analysis included only those patients who complied with the study protocol. After completing 2 weeks of treatment, seven out of 51 randomized patients did not finish the study protocol due to non-compliance to splinting, illness and lost to follow-up. Those patients were excluded from PP analysis. Participants were similar in all clinical, electrophysiological and demographic respects (p>0.05). An improvement was found in all parameters (VAS, FSS, SSS, mMDL and mSDL) for all groups at the end of the treatment and 8th week. It was found that pain score was significantly lower in group 3 compared to other treatment groups at 8th week according to ITT and PP analysis (p= 0.002, p=0.004 and p=0.001, p=0.001).
                Ketoprofen PH as adjuvant therapy on splinting is effective with respect to reduction of pain. Adding US therapy to the splinting is not superior to the splinting alone in patients with CTS. 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. 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. This study aimed to compare the efficacy of ultrasound treatment to local corticosteroid injection plus splinting in carpal tunnel syndrome (CTS). There is still limited knowledge on the efficacy of conservative treatment options for CTS.
                Fourty-nine hands of 34 patients with CTS were enrolled in this study. Patients were randomly assigned to the ultrasound treatment (group A) or local corticosteroid injection plus splinting (group B). The primary outcome measures included clinical parameters such as symptoms severity score, visual analogue scale (VAS) pain, functional status score, grip strength and two-point discrimination. The secondary outcome measures were the electrophysiological tests. The examinations were performed at baseline, and then at 4th and 8th weeks.
                At the end of the study, a statistically significant improvement was obtained in all clinical parameters in the group B: VAS pain, severity of symptoms, functional status, grip strength (p < 0.001 for each) and two-point discrimination (p < 0.016). Also the group A showed significant improvements in all clinical parameters (p < 0.001 for each), except for the grip strength. Additionally, significant improvements in the median nerve sensory conduction velocity and distal motor latency were also found in both groups at the end of the 8 week follow-up period. There was no significant difference between the groups in the primary and secondary outcome measures, except for the grip strength.
                Both ultrasound treatment and corticosteroid injection plus splinting were effective on the clinical symptoms and the electrophysiological findings of CTS. Thus, the ultrasound therapy may be an alternative treatment for CTS, particularly in patient who do not accept injection or splinting (Tab. 3, Fig. 2, Ref. 36). Randomized, controlled trial.
                To assess the believability of a novel sham intervention for a neurodynamic technique (NDT) in participants with signs and symptoms of carpal tunnel syndrome (CTS). Additionally, we wished to assess a potential mechanism of NDT (hypoalgesia) and to compare outcomes related to clinical pain and upper extremity disability between NDT and a sham intervention.
                Preliminary evidence suggests that NDT is effective in the treatment of CTS. A sham-controlled study is lacking from the literature and could provide insight to the efficacy of NDT, as well as the corresponding mechanisms.
                Participants with signs and symptoms consistent with CTS provided baseline measures of expectation, clinical pain intensity, upper extremity disability, and experimental pain sensitivity. Participants were then randomly assigned to receive either a NDT known to anatomically stress the median nerve or a sham technique intended to minimize stress to the median nerve. Following brief exposure to the assigned technique, expectation was reassessed to observe for group-dependent changes. Participants received the assigned intervention over 3 weeks. Additionally, all participants received a prefabricated wrist splint for their involved hands, with instructions to sleep in the splint and to wear it during painful activities when awake. Following 3 weeks of the assigned intervention and splint wear, baseline measures were reassessed and participants were asked which intervention they believed they had received.
                Forty females agreed to participate. Expectations for pain relief and perceived group assignment were similar between the groups. Within-session decreases in clinical pain intensity and pressure pain sensitivity were observed independent of group assignment. Reduction of temporal summation was observed only in participants receiving NDT. Significant improvements in clinical pain intensity and upper extremity disability were observed at 3 weeks, independent of group assignment.
                The sham intervention was successful in blinding the participants. Immediate changes in pain sensitivity and intensity and 3-week changes in clinical pain intensity and upper extremity disability associated with NDT were equivalent to a sham intervention to which the participants were adequately blinded. Conversely, reduction of temporal summation was only observed in participants receiving the NDT, suggesting the potential of a favorable neurophysiological effect. The purpose of this clinical trial was to evaluate the impact of a 4-month comprehensive protocol of strengthening and flexibility exercises developed by our research group versus conventional exercises for patients with Ankylosing Spondylitis (AS) on functional and mobility outcomes.
                Randomized controlled trial. Forty-five patients diagnosed with AS according to the modified criteria of New York were allocated to control or experimental groups using a random numbers table. The control group was treated with a conventional protocol of physical therapy in AS, whereas the experimental group was treated with the protocol suggested by our research group. The conventional intervention consisted of 20 exercises: motion and flexibility exercises of the cervical, thoracic, and lumbar spine; stretching of the shortened muscles; and chest expansion exercises. The experimental protocol is based on the postural affectation of the AS and the treatment of the shortened muscle chains in these patients according to the Global Posture Reeducation (GPR) method. This intervention employs specific strengthening and flexibility exercises in which the shortened muscle chains are stretched and strengthened. The study lasted 4 mos. During this period, patients received a weekly group session managed by an experienced physiotherapist. Each session lasted an hour, and there were 15 total sessions. Changes in activity, mobility, and functional capacity were evaluated by an assessor blinded to the intervention, using the following previously validated scores from the Bath group: BASMI (tragus to wall distance, modified Schober test, cervical rotation, lumbar side flexion, and intermalleolar distance), BASDAI (The Bath Ankylosing Spondylitis Disease Activity Index), and BASFI (The Bath Ankylosing Spondylitis Functional Index).
                Both groups showed an improvement (prepost scores) in all the outcome measures, mobility measures of the BASMI index, as well as in BASFI and BASDAI indexes. In the control group, the improvement in tragus to wall distance (P=0.009) and in lumbar side flexion (P=0.02) was statistically significant. Although the rest of the outcomes also improved, they did not reach a significant level (P>0.05). In the experimental group, the improvement in all the clinical measures of the BASMI index (P<0.01) and in the BASFI index (P=0.003) was statistically significant. The intergroup comparison between the improvement (prepost scores) in both groups showed that the experimental group obtained a greater improvement than the control group in all the clinical measures of the BASMI index, except in tragus to wall distance, as well as in the BASFI index.
                The experimental protocol developed by our research group, based on the GPR method and specific strengthening and flexibility exercises of the muscle chains, offers promising results in the management of patients suffering from AS. Further trials on this topic are required. Forty-two patients with subacromial impingement syndrome entered a randomized prospective study comparing open anterior acromioplasty with a physiotherapy regime. The criterion for a successful outcome of treatment was a reduction of the initial pain score of more than 50% using the visual analogue scale (VAS) technique. The evaluation was performed by an independent observer. At the 6-month follow-up, treatment in the surgical group had been successful in 12/21 (57%) patients versus 6/18 (33%) in the physiotherapy group. A one-year evaluation revealed 16/21 (76%) "successes" in the surgical group. A direct and unbiased comparison with the physiotherapy group was not possible at one year, since 13 patients chose surgery after initial physiotherapy. However, in "an intention to treat" analysis outcome at one year was significantly better in those randomized to surgery. We found two standardized, composite, active movements--the "Pour out of a Pot" manoeuvre requiring the emptying of a pot of water, and the "Hand in Neck" manoeuvre--to be of predictive value for the outcome of surgery. When combining three pain-related variables into a criterion for prediction of success, a sensitivity of 78% (p < 0.02) and a specificity of 90% (p < 0.03) were attained. We advance the hypothesis that pain in the impingement syndrome is mainly elicited by comparison of the subacromial bursa. In some patients a traction-responsive pain generator in the supraspinatus tendon may be present as well.
There is insufficient evidence either for or against the use of stabilisation splint therapy for the treatment of temporomandibular pain dysfunction syndrome. This review suggests the need for further, well conducted RCTs that pay attention to method of allocation, outcome assessment, large sample size, and enough duration of follow up. A standardisation of the outcomes of the treatment of PDS should be established in the RCTs .