EFFects of Exposure and Cognitive behavioral Therapy for chronic BACK pain ("EFFECT-BACK"): study protocol for a randomized controlled trial.

INTRODUCTION: Chronic back pain is a widespread medical condition associated with high socioeconomic costs and increasing prevalence. Despite the advanced implementation of multidisciplinary approaches, providing a satisfactory treatment offer for those affected is often not possible. Exposure therapy (EXP) promises to be an effective and economical form of treatment and in a previous pilot study showed to be superior to cognitive behavioral therapy (CBT) in reducing perceived limitations of movement. The current study aims to further compare the efficacy of both treatment methods and identify those patient groups that particularly benefit from EXP. METHODS: The general objective of this randomized multicenter clinical trial (targeted N = 380) is to improve and expand the range of treatments available to patients with chronic back pain. As the primary objective of the study, two different psychological treatments (EXP and CBT) will be compared. The primary outcome measure is a clinically significant improvement in pain-related impairment, measured by the QPBDS, from baseline to 6-month follow-up. Secondary outcome measures are absolute changes and clinically significant improvements in variables coping, psychological flexibility, depressiveness, catastrophizing, exercise avoidance and fear of exercise, and intensity of pain. Participants are recruited in five psychological and medical centers in Germany and receive ten sessions of manualized therapy by trained licensed CBT therapists or clinical psychologists, who are currently in their post-gradual CBT training. Potential predictors of each treatment's efficacy will be explored with a focus on avoidance and coping behavior. CONCLUSION: This study will be the first RCT to compare CBT and EXP in chronic back pain in a large sample, including patients from different care structures due to psychological and medical recruitment centers. By identifying and exploring potential predictors of symptom improvement in each treatment group, this study will contribute to enable a more individualized assignment to treatment modalities and thus improves the care situation for chronic back pain and helps to create a customized treatment program for subgroups of pain patients. If our findings confirm EXP to be an efficacious and efficient treatment concept, it should gain more attention and be further disseminated. TRIAL REGISTRATION: ClinicalTrials.gov NCT05294081. Registered on 02 March 2022.

Sustainability of cognitive behavioural interventions for chronic back pain: A long-term follow-up.

BACKGROUND: There is a significant research gap with respect to the long-term sustainability of psychological treatment effects in chronic pain patients. This study aimed to investigate long-term treatment effects of two psychological treatments: cognitive behavioural therapy (CBT) as a broad-spectrum approach and exposure as a specific intervention for fear-avoidant pain patients. METHODS: Patients with chronic low back pain were randomized to CBT or exposure in vivo. Long-term follow-up (LTFU) data were available for 64 patients up to 8 years after treatment, with a response rate of 73%. The primary outcomes were pain-related disability and pain intensity and secondary outcomes were emotional distress, psychological flexibility, catastrophizing and pain-related fear. The data analysis was performed with longitudinal multilevel modelling. RESULTS: Multilevel analyses showed improvements in all primary outcomes as well as all secondary outcomes from pre-treatment to LTFU for both treatments. The mean proportion of cases meeting reliable and clinical improved criteria in all primary outcome was 36% (range: 22%-46%) in the exposure group and 50% (range: 33%-60%) in the CBT group. Dropout analyses revealed significantly higher deterioration rates over time. Pre-treatment to LTFU effect sizes of the primary outcomes ranged from 0.54 to 1.59. CONCLUSIONS: Our results indicate that the effects of psychological treatments might be stable over several years. Treatment gains for exposure as a stand-alone treatment seem to be of shorter duration than a general CBT intervention. Thus, psychological treatments might offer a promising and sustainable long-term perspective for patients with chronic back pain. SIGNIFICANCE: The long-term stability of treatment effects is a highly neglected issue despite its inherent importance in the context of chronic pain. This study is the first to investigate treatment effects of cognitive behavioural therapy and in vivo exposure in chronic back pain sufferers up to 8 years after treatment. The findings contribute to an understanding of the sustainability of psychological cognitive behavioural therapy-based intervention effects.

Rebound pain and postoperative pain profile following brachial plexus block compared to general anaesthesia-An observational study.

BACKGROUND: Regional anaesthesia has the benefit of reducing the need for systemic analgesia and therefore, potentially reducing undesired side effects. With the end of the sensory nerve block however, many patients report severe pain that requires therapy with opioids and often compromise the initial opioid sparing effect. This study aimed to characterise the postoperative pain profile and the phenomenon of rebound pain after axillary brachial plexus anaesthesia (RA) compared to general anaesthesia (GA). DESIGN: Single-centre observational, stratified cohort study. SETTING: The study was conducted at University Hospital Marburg from May 2020 until September 2022. PARTICIPANTS: One hundred thirty-two patients receiving elective hand and forearm surgery were enrolled in this study. INTERVENTIONS: Group RA received ultrasound-guided brachial plexus anaesthesia via the axillary approach with 30 mL of prilocaine 1% and 10 mL ropivacaine 0.2%. Group GA received balanced or total intravenous general anaesthesia. MAIN OUTCOME MEASURES: Primary endpoint were integrated pain scores (IPS) within 24 h postoperatively. Secondary endpoints were pain scores (NRS 0-10), morphine equivalents, patient satisfaction, quality of recovery and opioid-related side effects. RESULTS: One hundred thirty-two patients were analysed of which 66 patients received brachial plexus block and 66 patients received general anaesthesia. Following RA significantly lower IPS were seen directly after surgery (p < .001) and during the post-anaesthesia care unit interval (p < .001) but equalised after 3 h at the ward. No overshoot in pain scores or increased opioid consumption could be detected. Patient satisfaction and postoperative recovery were comparable between both groups. CONCLUSION: The IPS and NRS was initially lower in the RA group, increased with fading of the block until equal to the GA group and equal thereafter. Although various definitions of rebound pain were met during this phase, the opioid sparing effect of regional anaesthesia was not counteracted by it. The incidence of episodes with uncontrolled, severe pain did not differ between groups. We found no clinical implications of rebound pain in this setting, since the RA group did not show higher pain scores than the GA group at any time point. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00021764).

Futility and Shared Decision-Making.

Medical futility is an ancient and yet consistent challenge in clinical medicine. The means of balancing conflicting priorities and stakeholders' preferences has changed as much as the science that powers the understanding and treatment of disease. The introduction of patient self-determination and choice in medical decision-making shifted the locus of power in the physician-patient relationship but did not obviate the physician's responsibilities to provide benefit and prevent harm. As we have refined the process in time, new paradigms, specialists, and tools have been developed to help navigate the ever-changing landscape.

Same same, but different: effects of likelihood framing on concerns about a medical disease in patients with somatoform disorders, major depression, and healthy people.

BACKGROUND: Research has shown that patients with somatoform disorders (SFD) have difficulty using medical reassurance (i.e. normal results from diagnostic testing) to revise concerns about being seriously ill. In this brief report, we investigated whether deficits in adequately interpreting the likelihood of a medical disease may contribute to this difficulty, and whether patients' concerns are altered by different likelihood framings. METHODS: Patients with SFD (N = 60), patients with major depression (N = 32), and healthy volunteers (N = 37) were presented with varying likelihoods for the presence of a serious medical disease and were asked how concerned they are about it. The likelihood itself was varied, as was the format in which it was presented (i.e. negative framing focusing on the presence of a disease v. positive framing emphasizing its absence; use of natural frequencies v. percentages). RESULTS: Patients with SFD reported significantly more concern than depressed patients and healthy people in response to low likelihoods (i.e. 1: 100 000 to 1:10), while the groups were similarly concerned for likelihoods ⩾1:5. Across samples, the same mathematical likelihood caused significantly different levels of concern depending on how it was framed, with the lowest degree of concern for a positive framing approach and higher concern for natural frequencies (e.g. 1:100) than for percentages (e.g. 1%). CONCLUSIONS: The results suggest a specific deficit of patients with SFD in interpreting low likelihoods for the presence of a medical disease. Positive framing approaches and the use of percentages rather than natural frequencies can lower the degree of concern.

Risk factors and protective factors of acute postoperative pain: an observational study at a German university hospital with cross-sectional and longitudinal inpatient data.

OBJECTIVES: Surgical fear is one of the most important psychological risk factors for postoperative pain, but less is known about the contribution of protective factors. This study investigated somatic and psychological risk and resilience factors of postoperative pain and validated the German version of the Surgical Fear Questionnaire (SFQ). SETTING: University Hospital of Marburg, Germany. DESIGN: Single-centre observational study and cross-sectional validation study. PARTICIPANTS: Data for validating the SFQ were obtained from a cross-sectional observational study (N=198, mean age 43.6 years, 58.8% female) with persons undergoing different kinds of elective surgery. A sample of N=196 (mean age 43.0 years, 45.4% female) undergoing elective (orthopaedic) surgery was analysed to investigate somatic and psychological predictors of relevant acute postsurgical pain (APSP). OUTCOME MEASURES: Participants completed preoperative and postoperative assessments at postoperative days 1, 2 and 7. Presurgical pain, age, gender, pain expectation, surgical setting, physical status, anaesthesia, surgical fear, pain catastrophising, depression, optimism and self-efficacy were examined as predictors. RESULTS: Confirmatory factor analysis confirmed the original two-factor structure of the SFQ. Correlation analyses indicated good convergent and divergent validity. Internal consistency (Cronbach's α) was between 0.85 and 0.89. Blockwise logistic regression analyses for the risk of APSP revealed outpatient setting, higher preoperative pain, younger age, more surgical fear and low dispositional optimism as significant predictors. CONCLUSIONS: The German SFQ is a valid, reliable and economical instrument with which the important psychological predictor surgical fear can be assessed. Modifiable factors that increase the risk of postoperative pain were higher pain intensity before surgery and being fearful about negative consequences of the surgery whereas positive expectations seem to buffer against postsurgical pain. TRIAL REGISTRATION NUMBERS: DRKS00021764 and DRKS00021766.

How the integration of normal medical test results can be improved in patients with somatoform disorders-An experimental study.

BACKGROUND: We examined whether the difficulties of patients with somatoform disorders (SFDs) in integrating medical reassurance can be altered by preventing patients from devaluing reassuring information through defensive cognitive strategies. METHOD: Patients with SFD (n = 60), patients with major depression (n = 32), and healthy volunteers (n = 37) watched a videotaped doctor's report, which provided medical reassurance for gastroenterological complaints. Subsequently, participants were asked about their perception of the report. In the SFD sample, patients' appraisal of the reassuring was experimentally modulated: In one condition, doubts about the validity of the doctor's diagnostic assessment were triggered; in another condition, the devaluation of medical reassurance was blocked through underscoring the validity of the doctor's diagnostic assessment; and a control condition received no manipulation. RESULTS: As evident on all outcome variables, patients with SFD had more difficulty integrating medical reassurance than depressed and healthy people. Within the SFD sample, participants from the experimental condition blocking the devaluation of medical reassurance rated the likelihood of an undetected serious disease to be significantly lower than the other two conditions. They also reported less emotional concern and a lower desire to seek the opinion of another doctor. CONCLUSIONS: By comparing patients with SFD to both a healthy and a clinical control group, the current study suggests that the difficulty in processing reassuring medical information is a specific psychopathological feature of SFD. Furthermore, our results suggest that the integration of medical reassurance can be improved by preventing patients from devaluing reassuring information through dismissive cognitive strategies. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

[Rebound pain-From definition to treatment]. / "Rebound pain" ­ von der Definition bis zur Therapie.

BACKGROUND: Rebound pain as a side effect of regional anaesthesia is an excessive sensation of pain after the effect of local anaesthesia has subsided. This sensation goes well beyond the normal wound pain following a surgical intervention. This phenomenon has entered focus of research in the past 10 years now, but the specific causes are so far unclear and there are still no targeted treatment recommendations. OBJECTIVE: This review article is intended to give the readership an overview of the current state of research about rebound pain. The theories of pathophysiology are presented and prophylaxis as well as treatment strategies are explained. MATERIAL AND METHODS: For this review article, the publications about rebound pain that appeared from 2005 up to May 2021 in PubMed were reviewed and the authors' definitions of rebound pain as well as the assumptions on pathophysiology and treatment recommendations were summarized. RESULTS AND DISCUSSION: A total of 22 original papers from the years 2005-2021 were evaluated regarding the differences between the definitions of rebound pain, the assumption of its occurrence as well as possible treatment options. It turns out that there is no uniform definition by the professional societies, the pathophysiology has not yet been clearly identified and no clear recommendations for prophylaxis or treatment can be given to date; however, early administration of pain medication (e.g. NSAIDs) before the end of the nerve block has proven to be helpful. Likewise, dexamethasone as an adjuvant to regional anaesthesia shows positive effects regarding the occurrence of rebound pain. In any case, it makes sense to provide patients with comprehensive information about this special side effect of regional anaesthesia so that those affected can correctly classify the excessive pain reaction. Targeted studies to avoid severe pain after regional anaesthesia, e.g. through the addition of adjuvants, are necessary in order to keep side effects as low as possible and thereby improve patient comfort and the acceptance of regional anaesthesia.

Effects of a video intervention on physicians' acceptance of pain apps: a randomised controlled trial.

OBJECTIVES: The aim of our study was to determine and enhance physicians' acceptance, performance expectancy and credibility of health apps for chronic pain patients. We further investigated predictors of acceptance. DESIGN: Randomised experimental trial with a parallel-group repeated measures design. SETTING AND PARTICIPANTS: 248 physicians working in various, mainly outpatient settings in Germany. INTERVENTION AND OUTCOME: Physicians were randomly assigned to either an experimental group (short video about health apps) or a control group (short video about chronic pain). Primary outcome measure was acceptance. Performance expectancy and credibility of health apps were secondary outcomes. In addition, we assessed 101 medical students to evaluate the effectiveness of the video intervention in young professionals. RESULTS: In general, physicians' acceptance of health apps for chronic pain patients was moderate (M=9.51, SD=3.53, scale ranges from 3 to 15). All primary and secondary outcomes were enhanced by the video intervention: A repeated-measures analysis of variance yielded a significant interaction effect for acceptance (F(1, 246)=15.28, p=0.01), performance expectancy (F(1, 246)=6.10, p=0.01) and credibility (F(1, 246)=25.61, p<0.001). The same pattern of results was evident among medical students. Linear regression analysis revealed credibility (ß=0.34, p<0.001) and performance expectancy (ß=0.30, p<0.001) as the two strongest factors influencing acceptance, followed by scepticism (ß=-0.18, p<0.001) and intuitive appeal (ß=0.11, p=0.03). CONCLUSIONS AND RECOMMENDATIONS: Physicians' acceptance of health apps was moderate, and was strengthened by a 3 min video. Besides performance expectancy, credibility seems to be a promising factor associated with acceptance. Future research should focus on ways to implement acceptability-increasing interventions into routine care.

How expectancy violations facilitate learning to cope with pain - An experimental approach.

BACKGROUND: Expectations of painful sensations constitute a core feature of chronic pain. An important clinical question is whether such expectations are revised when disconfirming experiences are made (e.g., less pain than expected). This study examined how people adjust their pain expectations when the experience of decreasing pain is expected vs. unexpected. METHODS: In a novel randomized between-subjects design, a subclinical sample of people who frequently experience pain was provided with painful thermal stimulations. Unbeknownst to participants, the temperature applied was decreased from trial to trial. Based on the experimental instructions provided, this experience of decreasing pain was expected in one condition (expectation-confirmation; n = 34), whereas it was unexpected in another (expectation-disconfirmation; n = 39). RESULTS: Perceived pain intensity was lower in the expectation-confirmation condition than in the expectation-disconfirmation condition (p = .014, ηp2 = 0.083). The expectation-confirmation condition also showed a greater adjustment of their pain expectations than the expectation-disconfirmation condition (p = .046, ηp2 = 0.047). Across groups, large expectation violations (i.e., less pain than expected) were associated with increases in pain tolerance and the ability to cope with pain at a one-week follow-up. CONCLUSIONS: In terms of assimilation, perceived pain intensity was shaped in the direction of pain expectations. The greater adjustment of expectations in the expectation-confirming condition is consistent with a confirmation bias in pain perception. Though participants who experienced large discrepancies between expected and experienced pain were hesitant to adjust their pain expectations immediately, expectation violations increased their ability to cope with pain one week later, suggesting some beneficial longer-term effects of expectation violations.

Indoor or Outdoor? Generalization of Costly Pain-Related Avoidance Behavior to Conceptually Related Contexts.

When pain persists beyond healing time and becomes a "false alarm" of bodily threat, protective strategies, such as avoidance, are no longer adaptive. More specifically, generalization of avoidance based on conceptual knowledge may contribute to chronic pain disability. Using an operant robotic-arm avoidance paradigm, healthy participants (N = 50), could perform more effortful movements in the threat context (eg, pictures of outdoor scenes) to avoid painful stimuli, whereas no pain occured in the safe context (eg, pictures of indoor scenes). Next, we investigated avoidance generalization to conceptually related contexts (ie, novel outdoor/indoor scenes). As expected, participants avoided more when presented with novel contexts conceptually related to the threat context than in novel exemplars of the safe context. Yet, exemplars belonging to one category (outdoor/indoor scenes) were not interchangeable; there was a generalization decrement. Posthoc analyses revealed that contingency-aware participants (n = 27), but not non-aware participants (n = 23), showed the avoidance generalization effect and also generalized their differential pain-expectancy and pain-related fear more to novel background scenes conceptually related to the original threat context. In contrast, the fear-potentiated startle response was not modulated by context. PERSPECTIVE: This article provides evidence for contextual modulation of avoidance behavior and its generalization to novel exemplars of the learned categories based on conceptual relatedness. Our findings suggest that category-based generalization is a plausible mechanism explaining why patients display avoidance behavior in novel situations that were never directly associated with pain.

Cognitive Change and Relaxation as Key Mechanisms of Treatment Outcome in Chronic Pain: Evidence From Routine Care.

Despite effective treatment approaches within the cognitive behavioral framework general treatment effects for chronic pain are rather small to very small. Translation from efficacy trials to naturalistic settings is questionable. There is an urgent need to improve the effectiveness of well-established treatments, such as cognitive-behavior therapy (CBT) and the investigation of mechanisms of change is a promising opportunity. We performed secondary data analysis from routine data of 1,440 chronic pain patients. Patients received CBT in a multidisciplinary setting in two inpatient clinics. Effect sizes and reliable change indices were computed for pain-related disability and depression. The associations between changes in the use of different pain coping skills (cognitive restructuring, activity despite pain, relaxation techniques and mental distraction) and changes in clinical outcomes were analyzed in structural equation models. Pre-post effect sizes range from g = 0.47 (disability) to g = 0.89 (depression). Changes in the use of cognitive restructuring, relaxation and to a lesser degree mental distraction were associated with changes in disability and depression. Effects from randomized trials can be translated to naturalistic settings. The results complement experimental research on mechanisms of change in the treatment of chronic pain and indicate an important role of cognitive change and relaxation as mechanisms of change. Our findings cautiously suggest that clinicians should optimize these processes in chronic pain patients to reduce their physical and emotional disability.

Behavioral Test (BAT-Back): Preliminary Evidence for a Successful Predictor of Treatment Outcome After Exposure Treatment for Chronic Low Back Pain.

OBJECTIVES: Although several questionnaires assessing fear of movement exist, it is still a challenge to identify individuals who might benefit more from exposure for chronic pain than from other psychological approaches and vice versa. Psychological approaches to chronic pain cannot advance toward the often called-for "tailored approaches" because of limited knowledge about treatment predictors. Our aim was to evaluate the additional predictive value of avoidance behavior based on behavioral observation. METHODS: This study examined pretreatment self-report and behavioral measures as predictors of treatment outcome for n=43 patients experiencing disabling chronic low back pain, who took part in a randomized controlled trial in which they received 10 to 15 sessions of exposure treatment. Only patients with elevated fear avoidance based on self-report measures were included. Data were analyzed using regression analyses and classification and regression trees. RESULTS: Regression analyses showed that higher avoidance behavior at pretreatment as measured by the Behavioral Avoidance Test-Back Pain (BAT-Back) significantly predicted reduction in global disability (with a small to medium effect), but not in specific disability. Self-report measures failed to predict treatment success for both outcome measures. Classification and regression trees divide subgroups who might benefit from exposure treatment through a BAT-Back score of >22 for Pain Disability Index. DISCUSSION: There is some preliminary evidence that pretreatment avoidance behavior might be an indicator for reduction in global disability after exposure treatments in patients experiencing disabling chronic low back pain and elevated fear avoidance. We identified preliminary cutoff scores that need further investigation.

Generalizability of harm and pain expectations after exposure in chronic low back pain patients.

BACKGROUND: Exposure treatments are shown to be effective in reducing pain-related fear and the perceived harmfulness of physical activities. However, due to the fragility of extinction its stability is questionable. We investigated the generalizability of exposure effects in chronic low back pain (CLBP) patients by integrating a behavioral test in the context of an intervention study. METHODS: The study is an additional analysis of a randomized controlled trial investigating the efficacy of exposure in vivo. A total of 67 CLBP patients were randomly assigned to one of the three groups: Exposure-short (EXP-S); exposure-long (EXP-L) and cognitive behavioral therapy (CBT). Participants rated the expected harmfulness of daily activities (Photograph Series of Daily Activities) before and after therapy. Post-treatment participants were confronted with an individually tailored, threatening movement in a new context. Harm and pain expectations before the exposure were compared to the actual experience after exposure. RESULTS: We found that EXP leads to more strongly reduced harm expectations (F(2,50) = 11.37, p < .001, η2  = 0.31) compared to CBT, regardless of the duration of EXP. After therapy, patients expected less harm (F(2,50) = 3.61, p = .034, η2  = 0.13) but not less pain (F(2,50) = 3.61, p = .034, η2  = 0.13) when confronted with a novel movement. CONCLUSIONS: Exposure successfully reduced harm but not pain expectations in patients with CLBP. Further, preliminary results showed that these specific exposure effects were generalized to a novel activity in a different context outside therapy. SIGNIFICANCE: This study investigats the generalizability and stability of exposure effects in patients with CLBP by combining a behavioral test with an intervention study. We found strong and stable effects on harm expectations but not on pain expectations. Results show promising preliminary evidence that reduced harm expectations can be generalized to a novel threatening activity in a new context. Clinical implications of our findings suggest that exposure treatment would benefit from a clear focus on harm expectations.

World-Wide Efficacy of Bone Marrow Derived Mesenchymal Stromal Cells in Preclinical Ischemic Stroke Models: Systematic Review and Meta-Analysis.

Background: Following extensive, positive results in pre-clinical experiments, Bone Marrow Derived-Mesenchymal Stromal Cells (BM-MSCs) are now being tested as a novel therapy for ischemic stroke in ongoing clinical trials. However, multiple critical questions relating to their translational application remain to be clarified. We performed a comprehensive, systematic review and meta-analysis of pre-clinical studies to evaluate the efficacy of BM-MSCs on functional outcomes after ischemic stroke, as well as the independent role of translational factors on their effect size. Methods: We systematically reviewed the literature and identified articles using BM-MSCs in animal models of focal ischemic stroke. After abstraction of all relevant data, we performed a meta-analysis to estimate the combined effect size of behavioral endpoints after BM-MSC administration. To describe the effect size across many behavioral outcomes, we divided these outcomes into four categories: (1) Composite scores, (2) Motor Tests, (3) Sensorimotor Tests, and (4) Cognitive Tests. We also performed a meta-regression analysis for measuring the effect of individual characteristics of BM-MSC administration on the effect size. Results: Our results from 141 articles indicate a significant beneficial effect on composite, motor, and sensorimotor outcomes after treatment with BM-MSCs compared to control groups. We found no major differences in treatment effect based on delivery route, dose, fresh vs. frozen preparation, or passage number. There were no consistent findings supporting a difference in treatment effect based on time windows from acute periods (0-6 h) vs. later windows (2-7 days). Furthermore, these positive treatment effects on functional outcome were consistent across different labs in different parts of the world as well as over the last 18 years. There was a negative correlation between publication year and impact factor. Conclusions: Our results show worldwide efficacy of BM-MSCs in improving functional outcomes in pre-clinical animal models of stroke and support testing these cells in clinical trials in various ranges of time windows using different delivery routes. The continued growing number of publications showing functional benefit of BM-MSCs are now adding limited value to an oversaturated literature spanning 18 years. Researchers should focus on identifying definitive mechanisms on how BM-MSCs lead to benefit in stroke models.

Exposure and CBT for chronic back pain: An RCT on differential efficacy and optimal length of treatment.

OBJECTIVE: Our aim was to establish whether Exposure, a specialized tailored treatment for chronic low back pain, has any advantages over cognitive-behavioral therapy (CBT) among individuals with high fear-avoidance levels. Second, we planned to compare short and long versions of Exposure. Third, we aimed to investigate whether Exposure can be delivered in an outpatient psychological setting. METHOD: A total of 88 Caucasian participants (55% women) were randomized to three different psychological treatment conditions, Exposure-long, Exposure-short, and CBT. All participants were suffering from chronic pain and elevated levels of pain-related anxiety and disability. The primary outcomes were disability (assessed using two different questionnaires, QBPDS and PDI) and average pain intensity; secondary outcomes included pain-related anxiety, psychological flexibility, coping strategies, and depression. Assessments took place at pretreatment, midtreatment, posttreatment, and 6-month follow-up. RESULTS: Exposure was more effective than CBT at reducing movement-related disability assessed with the QBPDS. Exposure and CBT did not differ in reduction of pain intensity or disability assessed using the PDI. Exposure-short outperformed Exposure-long after 10 sessions, meaning that individuals improved faster when they were offered fewer sessions. Exposure could be safely delivered in the psychological setting. Concerning secondary outcomes, Exposure led to greater improvements in psychological flexibility relative to CBT. CBT was more effective than Exposure at enhancing coping strategies. In Exposure, significantly more participants dropped out. CONCLUSIONS: Although being more challenging to patients, Exposure is an effective treatment, which can be delivered in a psychological treatment setting and should be offered as a short-term treatment. (PsycINFO Database Record

Development and Validation of the Behavioral Avoidance Test-Back Pain (BAT-Back) for Patients With Chronic Low Back Pain.

OBJECTIVES: Pain-related fear and avoidance of physical activities are central elements of the fear-avoidance model of musculoskeletal pain. Pain-related fear has typically been measured by self-report instruments. In this study, we developed and validated a Behavioral Avoidance Test (BAT) for chronic low back pain (CLBP) patients with the aim of assessing pain-related avoidance behavior by direct observation. MATERIALS AND METHODS: The BAT-Back was administered to a group of CLBP patients (N=97) and pain-free controls (N=31). Furthermore, pain, pain-related fear, disability, catastrophizing, and avoidance behavior were measured using self-report instruments. Reliability was assessed with intraclass correlation coefficient and Cronbach α. Validity was assessed by examining correlation and regression analysis. RESULTS: The intraclass correlation coefficient for the BAT-Back avoidance score was r=0.76. Internal consistency was α=0.95. CLBP patients and controls differed significantly on BAT-Back avoidance scores as well as self-report measures. BAT-Back avoidance scores were significantly correlated with scores on each of the self-report measures (rs=0.27 to 0.54). They were not significantly correlated with general anxiety and depression, age, body mass index, and pain duration. The BAT-Back avoidance score was able to capture unique variance in disability after controlling for other variables (eg, pain intensity and pain-related fear). DISCUSSION: Results indicate that the BAT-Back is a reliable and valid measure of pain-related avoidance behavior. It may be useful for clinicians in tailoring treatments for chronic pain as well as an outcome measure for exposure treatments.

Cross-cultural adaption of the German Quebec Back Pain Disability Scale: an exposure-specific measurement for back pain patients.

STUDY DESIGN: Cross-cultural translation and psychometric testing. OBJECTIVE: The purpose of the present study was to examine reliability and validity of a cross-cultural adaption of the German Quebec Back Pain Disability Scale (QBPDS) in a context of a randomized controlled trial evaluating the effectiveness of graded in vivo exposure in chronic low back pain patients. BACKGROUND: The QBPDS is one of the most widely used disease-specific disability questionnaires. In particular, for cognitive behavioral treatments with a clear focus on behavioral aspects such as graded in vivo exposure, the QBPDS provides an ascertained strategy with a sound conceptual basis and excellent quality criteria. Nevertheless, there is conflicting evidence concerning factor structure and a German adaption is missing. METHODS: The cross-cultural adaption followed international guidelines. Psychometric testing was performed using data from 180 participants with chronic low back pain. The psychometric analyses included internal consistency, convergent, and divergent validity. Exploratory factor analysis was used to determine the underlying factor structure. RESULTS: The QBPDS showed strong psychometric properties, with high internal consistency for the full scale (α=0.94) and good convergent and divergent validity. The factor analysis revealed a four-factor solution (bending, ambulation, brief effortful movements, and long-lasting postures). CONCLUSION: The translation and cross-cultural adaption of the QBPDS into German was successful. The German version proved to be a valid and reliable instrument and is well suited for use in the context of an exposure-based psychological treatment.

The Psychological Inflexibility in Pain Scale (PIPS) - validation, factor structure and comparison to the Chronic Pain Acceptance Questionnaire (CPAQ) and other validated measures in German chronic back pain patients.

BACKGROUND: Acceptance and Commitment Therapy (ACT) for pain offers an alternative to traditional Cognitive Behavioural Therapy (CBT) approaches. ACT focuses on the enhancement of 'psychological flexibility' that enables individuals to pursue their values and goals despite pain. To assess specific treatment effect or mediators and moderators of change, questionnaires measuring ACT constructs are needed. METHODS: The Psychological Inflexibility in Pain Scale (PIPS) was translated into German and completed by 182 participants with chronic back pain (70.3 % women, age 51.0 ± 10.5 years). Item analyses and a confirmatory factor analysis were computed as well as correlations with the Chronic Pain Acceptance Questionnaire (CPAQ), which measures related, but slightly different ACT-related constructs, and self-reported disability, pain intensity and further pain-related questionnaires. RESULTS: The confirmatory factor analysis reproduced the original structure with two subscales and a good fit. The internal consistencies of the subscales were Cronbach's α = .91 (Avoidance) and α = .26 (Fusion). Average item-whole correlations of the items with the respective subscales were r = .71 (Avoidance) and r = .20 (Fusion). The highest correlations were observed for Avoidance with the CPAQ (r = -.81), the Tampa Scale of Kinesiophobia (r = .58) and the Pain Catastrophizing Scale (r = .56) and for Fusion with the CPAQ subscale Pain willingness (r = -.55). The PIPS subscale Avoidance predicted pain-related disability even after controlling for catastrophizing and fear of movement. CONCLUSIONS: The PIPS subscale Avoidance may be a valuable instrument to assess treatment processes in future RCTs. The PIPS subscale Fusion seemed more problematic in the German sample with chronic back pain. More research on the comparison between PIPS and other questionnaires assessing psychological flexibility and the usefulness of the concept 'Fusion' for chronic pain are needed.