Efficacy of an early intervention for patients with acute temporomandibular disorder-related pain: a one-year outcome study. A randomized clinical trial of a tailored comprehensive care treatment program for temporomandibular disorders. Hypnosis in the management of persistent idiopathic orofacial pain--clinical and psychosocial findings. Should treatment of (sub)acute low back pain be aimed at psychosocial prognostic factors? Cluster randomised clinical trial in general practice. Efficacy of cognitive-behavioral intervention for juvenile primary fibromyalgia syndrome. Treatment of nonorganic recurrent abdominal pain: cognitive-behavioral family intervention. A family-based randomized controlled trial of pain intervention for adolescents with sickle cell disease. Randomized controlled trial of an Internet-delivered family cognitive-behavioral therapy intervention for children and adolescents with chronic pain. Brief group cognitive-behavioral intervention for temporomandibular disorders. Individually tailored treatment targeting activity, motor behavior, and cognition reduces pain-related disability: a randomized controlled trial in patients with musculoskeletal pain. Intensive physical and psychosocial training program for patients with chronic low back pain. A controlled clinical trial. Dysfunctional patients with temporomandibular disorders: evaluating the efficacy of a tailored treatment protocol. The efficacy of developmentally sensitive interventions and sucrose for relieving procedural pain in very low birth weight neonates. Results of a randomized controlled trial to examine the efficacy of a chronic pain self-management group for older adults [ISRCTN11899548]. Does systematic graded exposure in vivo enhance outcomes in multidisciplinary chronic pain management groups? A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury.
The authors conducted a randomized clinical trial to evaluate the efficacy of a biopsychosocial intervention for patients who were at high risk (HR) of progressing from acute to chronic temporomandibular disorder (TMD)-related pain.
                The authors classified subjects' risk using a predictive algorithm and randomized them into an early-intervention (EI) or a nonintervention (NI) group. The EI included cognitive behavioral skills training and biofeedback. The authors assessed pain and psychosocial measures at intake and at a one-year follow-up. Subjects' self-reported pain levels were measured on an analog scale and as a response to palpation.
                At one year, EI-group subjects had significantly lower levels of self-reported pain and depression. At one year, more NI-group subjects than EI-group subjects had utilized health care for jaw-related pain. NI-group subjects were 12.5 times as likely to have a somatoform disorder, more than seven times as likely to have an anxiety disorder, and 2.7 times more likely to have an affective disorder at one year, compared with EI-group subjects.
                EI-group subjects had reduced pain levels, improved coping abilities and reduced emotional distress at one year.
                The TMD-related pain experience is complex and requires early identification with a biopsychosocial EI to achieve maximal, sustainable results. 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. This controlled and patient blinded study tested the effect of hypnosis on persistent idiopathic orofacial pain (PIOP) in terms of clinical and psychosocial findings. Forty-one PIOP were randomized to active hypnotic intervention or simple relaxation as control for five individual 1-h sessions. Primary outcome was average pain intensity scored three times daily in a pain diary using visual analogue scale (VAS). Secondary outcome measures were pain quality assessed by McGill pain questionnaire (MPQ), psychological symptoms assessed by symptom check list (SCL), quality of life assessed by SF36, sleep quality, and consumption of analgesic. Data were compared between groups before and after treatment using ANOVA models and paired t-tests. The change in VAS pain scores from baseline to the last treatment (t4) was (33.1+/-7.4%) in the hypnosis group and (3.2+/-5.4%) in the control group (P<0.03). In the hypnosis group, highly hypnotic susceptible patients had greater decreases in VAS pain scores (55.0+/-12.3%) when compared to less susceptible patients (17.9+/-6.7%) (P<0.02). After the last treatment there were also statistically significant differences between groups in perceived pain area (MPQ) and the use of weak analgesics (P<0.03). There were no statistically significant changes in SCL or SF36 scores from baseline to t4. In conclusion, hypnosis seems to offer clinically relevant pain relief in PIOP, particularly in highly susceptible patients. However, stress coping skills and unresolved psychological problems need to be included in a comprehensive management plan in order also to address psychological symptoms and quality of life. To compare the effects of a minimal intervention strategy aimed at assessment and modification of psychosocial prognostic factors and usual care for treatment of (sub)acute low back pain in general practice.
                Cluster randomised clinical trial.
                60 general practitioners in 41 general practices.
                314 patients with non-specific low back pain of less than 12 weeks' duration, recruited by their general practitioner.
                In the minimal intervention strategy group the general practitioner explored the presence of psychosocial prognostic factors, discussed these factors, set specific goals for reactivation, and provided an educational booklet. The consultation took about 20 minutes. Usual care was not standardised.
                Functional disability (Roland-Morris disability questionnaire), perceived recovery, and sick leave because of low back pain assessed at baseline and after 6, 13, 26, and 52 weeks.
                The dropout rate was 8% in the minimal intervention strategy group and 9% in the usual care group. Multilevel analyses showed no significant differences between the groups on any outcome measure during 12 months of follow-up in the whole group or in relevant subgroups (patients with high scores on psychosocial measures at baseline or a history of frequent or prolonged low back pain).
                This study provides no evidence that (Dutch) general practitioners should adopt our new treatment strategy aimed at psychosocial prognostic factors in patients with (sub)acute low back pain. Further research should examine why our new strategy was not more effective than usual care. There are currently no controlled studies of behavioral interventions for juvenile primary fibromyalgia syndrome (JPFM). In this small-sample randomized study, we tested the efficacy of a behavioral intervention, i.e., coping skills training (CST), for the treatment of adolescents with JPFM. Outcomes tested in this study were functional disability, pain intensity, pain-coping efficacy, and depressive symptoms.
                Thirty patients with JPFM were randomly assigned to 8 weeks of either CST or self-monitoring. Adolescents in the CST condition received training in active pain-coping techniques, while those in the self-monitoring condition monitored daily pain intensity and sleep quality with no instructions about behavior change. After posttreatment assessment, subjects were crossed over into the opposite treatment arm for 8 weeks (so that all adolescents eventually received both CST and self-monitoring) and were reassessed at Week 16.
                At Week 8, adolescents in both conditions showed significant decrease in depressive symptoms and functional disability. Those who received CST showed significantly greater ability to cope with pain than those in the self-monitoring condition and a trend toward decreased pain intensity. At Week 16, adolescents had significantly lower levels of disability and depressive symptoms compared to baseline, but those who received self-monitoring followed by CST seemed to receive the most benefit.
                CST can lead to improved functioning among JPFM patients. Although some of the improvement may be due to increased monitoring and attention, CST provides the specific benefit of improving adolescents' ability to cope with pain. We evaluated the efficacy of cognitive-behavioral family intervention in the treatment of crises of pain in children with nonorganic recurrent abdominal pain (RAP) and the thresholds of pain for 17 body surface areas in these children.
                A randomized clinical trial was undertaken with 32 children between the ages of 5.1 and 13.9 years with nonorganic RAP. A group of 15 patients, aged 9.9 +/- 2.2 years (11 girls), received standard pediatric care and cognitive-behavioral family intervention for treatment of pain crises. The control group of 17 children, aged 8.4 +/- 2.0 years (11 girls), received only standard pediatric care. These procedures were undertaken by general pediatricians over 4 monthly sessions. An analog visual scale was used to measure the frequency and intensity of the pain crises per month and a mechanical pressure algometer for the measurement of pain threshold.
                The median frequency of pain crises per month reported by patients at the 3 monthly cognitive-behavioral family intervention sessions was 15, 5, 2 and 2, respectively. In contrast, the median frequency for pain crises per month reported by the control group was 12, 8, 10 and 8, respectively. The difference between the intervention group and the controls was statistically significant for frequency of pain at the second, third and fourth visits. There was no statistical difference for intensity of pain or for measured pain thresholds between the control and the intervention group.
                The cognitive-behavioral family intervention reduced the frequency of pain crises of children with nonorganic RAP. This successful intervention was carried out by the intervention of general pediatricians. The study had 2 aims---to determine the efficacy of a family-based cognitive-behavioral pain management intervention for adolescents with sickle cell disease (SCD) in (1) reducing pain and improving health-related variables and (2) improving psychosocial outcomes. Each adolescent and a family support person were randomly assigned to receive a brief pain intervention (PAIN) (n=27) or a disease education attention control intervention (DISEASE ED) (n=26) delivered at home. Assessment of primary pain and health-related variables (health service use, pain coping, pain-related hindrance of goals) and secondary psychosocial outcomes (disease knowledge, disease self-efficacy, and family communication) occurred at baseline (before randomization), postintervention, and 1-year follow-up. Change on outcomes did not differ significantly by group at either time point. When groups were combined in exploratory analyses, there was evidence of small to medium effects of intervention on health-related and psychosocial variables. Efforts to address barriers to participation and improve feasibility of psychosocial interventions for pediatric SCD are critical to advancing development of effective treatments for pain. Sample size was insufficient to adequately test efficacy, and analyses did not support this focused cognitive-behavioral pain management intervention in this sample of adolescents with SCD. Exploratory analyses suggest that comprehensive interventions, that address a broad range of skills related to disease management and adolescent health concerns, may be more effective in supporting teens during healthcare transition. Cognitive-behavioral therapy (CBT) interventions show promise for decreasing chronic pain in youth. However, the availability of CBT is limited by many factors including distance to major treatment centers and expense. This study evaluates a more accessible treatment approach for chronic pediatric pain using an Internet-delivered family CBT intervention. Participants included 48 children, aged 11-17 years, with chronic headache, abdominal, or musculoskeletal pain and associated functional disability, and their parents. Children were randomly assigned to a wait-list control group or an Internet treatment group. Primary treatment outcomes were pain intensity ratings (0-10 NRS) and activity limitations on the Child Activity Limitations Interview, both completed via an online daily diary. In addition to their medical care, the Internet treatment group completed 8 weeks of online modules including relaxation training, cognitive strategies, parent operant techniques, communication strategies, and sleep and activity interventions. Youth randomized to the wait-list control group continued with the current medical care only. Findings demonstrated significantly greater reduction in activity limitations and pain intensity at post-treatment for the Internet treatment group and these effects were maintained at the three-month follow-up. Rate of clinically significant improvement in pain was also greater for the Internet treatment group than for the wait-list control group. There were no significant group differences in parental protectiveness or child depressive symptoms post-treatment. Internet treatment was rated as acceptable by all children and parents. Findings support the efficacy and acceptability of Internet delivery of family CBT for reducing pain and improving function among children and adolescents with chronic pain. 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 compares the outcomes of an individually tailored behavioral medicine intervention (experimental) with physical exercise therapy (control). The experimental intervention was systematically individualized according to each participant's behavioral treatment goals and functional behavioral analyses. One hundred twenty-two patients seeking care at 3 primary health care clinics because of musculoskeletal pain were randomized. Ninety-seven completed the trial. Data were collected at baseline, immediately after treatment, and at a 3-month follow-up. Analyses of data from completers, as well as intention-to-treat analyses, showed that the experimental group experienced lower levels of disability (P = .01), lower maximum pain intensity (P = .02), higher levels of pain control (P = .001), and lower fear of movement (P = .022) as a result of treatment condition. Self-efficacy (P = .0001) and physical performance (P = .0001) increased over time for both groups. Participants in the experimental group generally reported more positive effects after treatment. Treatment fidelity was maintained during the course of the study. Activity can be resumed and pain might be managed by the patients themselves if treatment incorporates the biopsychosocial explanatory model of pain and strategies are tailored according to individual's priorities of everyday life activities and empirically derived determinants of pain-related disability.
                This study shows that the biomedical and the psychosocial perspectives of the experiences and consequences of pain complement rather than contradict each other. Primary health care patients with persistent musculoskeletal pain benefit more from a systematic tailoring of treatments according to biopsychosocial factors than from a physically based exercise intervention. The authors conducted a controlled clinical trial with 1-year follow-up to define the effectiveness of an intensive physical and psychosocial training program on patients with low back pain.
                The intervention group included 152 patients (mean age 40.5 yr, Million index 45.1/100), and the reference group included 141 patients (mean age 40.4 yr, Million-index 44.5/100).
                The progressive intervention program consisted of intensive physical training and psychosocial activation. The outcomes were physical and psychosocial measures, the pain and disability index (Million), sick leaves, and occupational handicap.
                The intervention was more efficient with respect to physical measures and pain and disability index. There were only mild or no differences in changes between the study groups in psychologic variables, sick leaves, or retirement.
                The intervention program could improve physical disability, but to improve occupational handicap, activities of the whole society (social legislation, labor market policy) are needed. 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. Procedural pain management for very low birth weight (VLBW) neonates has been minimal or nonexistent in most neonatal intensive care units (NICUs).
                To compare the efficacy of developmentally sensitive behavioral interventions (nonnutritive sucking via a pacifier, positioning) and sucrose for relieving procedural pain in VLBW infants and to determine the influence of contextual factors (gestational age, postnatal age, birth weight, severity of illness, frequency of painful procedures) on pain response.
                In a prospective randomized crossover trial, pain was assessed in 122 VLBW neonates using the Premature Infant Pain Profile following four randomly ordered interventions during consecutive routine heel lance procedures.
                Significant differences in pain existed among treatment interventions (F = 16.20, p < .0001). The pacifier with sucrose (F = 24.09, p < .0001) and pacifier with sterile water (F = 9.00, p = .003) significantly reduced pain. Prone positioning did not decrease pain (F = 2.24, p = .137). Frequency of painful procedures approached significance in influencing pain response (F = 3.59, p = .01).
                The most efficacious interventions for reducing pain from single painful events were the pacifier with sucrose and the pacifier with sterile water. Research on the efficacy and safety of implementing these interventions, alone and in combination, for repeated painful procedures is needed. In addition, research is needed on the influence of implementing these interventions on pain response and clinical outcomes (e.g., health status and neurodevelopmental status) in VLBW neonates in the NICU. Chronic pain is a common, disabling problem in older adults. Pain self-management training is a multimodal therapy that has been found to be effective in young to middle-aged adult samples; however, few studies have examined the effectiveness of this therapy in older adults. In this randomized, controlled trial, we evaluated a pain self-management training group (SMG) intervention as compared with an education-only (BOOK) control condition. Participants, 65 years of age or older who experienced persistent, noncancer pain that limited their activities, were recruited from 43 retirement communities in the Pacific Northwest of the United States. The primary outcome was physical disability, as measured by the Roland-Morris Disability Questionnaire. Secondary outcomes were depression (Geriatric Depression Scale), pain intensity (Brief Pain Inventory), and pain-related interference with activities (Brief Pain Inventory). Randomization occurred by facility to minimize cross-contamination between groups. Two-hundred and fifty-six individuals, mean age=81.8 (SD: 6.5), enrolled and 218 completed the study. No significant differences in outcomes were found between groups at post-intervention, 6-month follow-up, or 12-month follow-up. The SMG group showed a significantly greater increase over time, relative to the BOOK group, in two process measures, as measured by the Chronic Pain Coping Inventory: use of relaxation and use of exercise/stretching. In both cases, the increase was greatest from baseline to the post-intervention assessment. Study findings indicate that additional research is needed to determine the most effective content and delivery methods for self-management therapies targeted at older adults with chronic pain. 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. Past evidence has shown that motor cortical stimulation with invasive and non-invasive brain stimulation is effective to relieve central pain. Here we aimed to study the effects of another, very safe technique of non-invasive brain stimulation--transcranial direct current stimulation (tDCS)--on pain control in patients with central pain due to traumatic spinal cord injury. Patients were randomized to receive sham or active motor tDCS (2mA, 20 min for 5 consecutive days). A blinded evaluator rated the pain using the visual analogue scale for pain, Clinician Global Impression and Patient Global Assessment. Safety was assessed with a neuropsychological battery and confounders with the evaluation of depression and anxiety changes. There was a significant pain improvement after active anodal stimulation of the motor cortex, but not after sham stimulation. These results were not confounded by depression or anxiety changes. Furthermore, cognitive performance was not significantly changed throughout the trial in both treatment groups. The results of our study suggest that this new approach of cortical stimulation can be effective to control pain in patients with spinal cord lesion. We discuss potential mechanisms for pain amelioration after tDCS, such as a secondary modulation of thalamic nuclei activity.
There is weak evidence to support the use of psychosocial interventions for chronic orofacial pain. Although significant effects were observed for outcome measures where pooling was possible, the studies were few in number and had high risk of bias. However, given the non-invasive nature of such interventions they should be used in preference to other invasive and irreversible treatments which also have limited or no efficacy. Further high quality trials are needed to explore the effects of psychosocial interventions on chronic orofacial pain.