Dose-response relationship and effect modifier of stabilisation exercises in nonspecific low back pain: a project-wide individual patient data re-analysis on 1483 intervention participants.

ABSTRACT: This planned MiSpEx-Network reanalysis was designed to derive a dose-response relationship under consideration of further effect modifiers in exercises on low back pain. One thousand four hundred eighty three intervention participants with low back pain (mean age, 40.9 years [SD 14 years]) performed stabilisation exercises (3 weeks supervised, 9 weeks self-administered). Patients reported pain intensity, disability, and disability days at baseline, 3 weeks, 12 weeks, and 6 months post randomisation. Exercise characteristics and effect modifiers were prospectively monitored. Beyond the comparison to the results of the control group, linear mixed models were calculated to determine a dose-response relationship. The interventions led to small but significantly larger symptom reductions than in the control group at each measurement. Longer durations of the intervention led to larger symptom reductions. Higher exercise frequencies were associated with a decrease in pain intensity: to train once more per week led to a mean decrease of 0.93 points in pain intensity [95% CI = -1.54 to -0.32]. Disability days were also impacted (estimate = -0.07 [-0.14 to 0.00]), but disability was not (-0.09 [-0.67 to 0.48]). Adding perturbation was superior to adding stretching or a behavioural module. The relationships were robust when additional effect modifiers were considered and against the control group' effects. The odds ratio for a clinically important effect with higher exercise frequencies decreased at 3 weeks (OR = 0.71 [0.618-0.813] for >2.5*week -1 ) and increased at 12 weeks (1.13 [1.006-1.270], >1.5*week -1 ). Using longer intervention durations, adding a perturbation component to the stabilisation trainings and using higher frequencies (up to a certain point) may lead to an even more beneficial response on exercise in patients with low back pain. Developing strategies to maintain a training frequency of at least 2 times per week may be relevant in stabilisation exercises to treat low back pain.

Which Functional Outcomes Can be Measured in Low Back Pain Trials and Therapies?: A Prospective 2-Year Factor-, Cluster-, and Reliability-Multicenter Analysis on 42 Variables in 1049 Individuals.

STUDY DESIGN: Prospective 2-year factor-, cluster-, and reliability-multicenter analysis. OBJECTIVE: To provide evidence on the uniqueness and usefulness of a set of potential relevant functional outcomes. SUMMARY OF BACKGROUND DATA: A very high number of functional outcomes that can be utilized as variables in low back pain (LBP) trials exists. METHODS: Participants (n = 1049) with and without current LBP were included. At 7 visits (baseline, 4 wk, 3 mo, 6 mo, 9 mo, 1 yr, and 2 yr), 42 different functional outcomes were assessed. Two exploratory factor analyses (for baseline-values and for changes scores to 3 mo post-baseline) were calculated (maximum likelihood extraction, varimax factor rotation). The strongest factor-loading outcomes were selected for the following hierarchical cluster analyses (average linkage, Euclidean distance measure). For each cluster, time point, and outcome, reliability analyses were subsequently calculated using intraclass correlation coefficients, standard error of measurements and coefficients of variation. RESULTS: The factor analysis for the cross-sectional values revealed 9 factors with a cumulative variance explanation of 61.7% and 13 unique ones. The change-score factor analysis revealed nine factors with a total variance explanation of 61.8%, seven outcomes were unique. Ten outcomes were important for both cross-sectional and change-score analyses, 11 were most valuable for cross-sectional and four for the change scores. Patients with pain grades 1 to 3 show comparable patterns (cluster 2). Grade 0 (cluster 1) and grade 4 (cluster 3) are unique and cannot be cumulated with other grades. Most biomechanical outcomes were highly reliable and display low measurement errors. CONCLUSION: We found 25 potentially meaningful functional outcomes in the context of objective functional measurements (such as trunk range of motion, dynamic and static balance, strength, and muscle fatigue resistance) and body characteristics. The present framework may help to select appropriate functional outcomes and rate effects beyond the known core set of outcomes.Level of Evidence: 1.

Mobile Application-Based Interventions for Chronic Pain Patients: A Systematic Review and Meta-Analysis of Effectiveness.

Chronic pain is one of the major causes of disability in the general population. Even though there are effective treatment options available for reducing symptoms, these treatments often do not have consistent lasting effects. As the usage of mobile devices has increased enormously during the last few years, mobile application-based treatment options are widespread. Such app-based programs are not yet empirically proven but might enable patients to become more independent in their pain management in order to prevent relapse. The aim of this meta-analysis was to summarize the literature on mobile application-based interventions for chronic pain patients. Therefore, three electronic bibliographic databases, PubMed, PsycINFO, and Web of Science, were searched for studies that investigated the effectiveness of mobile application-based intervention for chronic pain on pain intensity. The final sample comprised twenty-two studies, with a total of 4679 individuals. Twelve of these twenty-two studies used a randomized control trial (RCT) design, while ten studies only used an observational design. For all twenty-two studies, a small but significant effect (d = -0.40) was found when compared to baseline measures or control groups. The results suggest that apps-based treatment can be helpful in reducing pain, especially in the long-term.

Motor Control Stabilisation Exercise for Patients with Non-Specific Low Back Pain: A Prospective Meta-Analysis with Multilevel Meta-Regressions on Intervention Effects.

Low-to-moderate quality meta-analytic evidence shows that motor control stabilisation exercise (MCE) is an effective treatment of non-specific low back pain. A possible approach to overcome the weaknesses of traditional meta-analyses would be that of a prospective meta-analyses. The aim of the present analysis was to generate high-quality evidence to support the view that motor control stabilisation exercises (MCE) lead to a reduction in pain intensity and disability in non-specific low back pain patients when compared to a control group. In this prospective meta-analysis and sensitivity multilevel meta-regression within the MiSpEx-Network, 18 randomized controlled study arms were included. Participants with non-specific low back pain were allocated to an intervention (individualized MCE, 12 weeks) or a control group (no additive exercise intervention). From each study site/arm, outcomes at baseline, 3 weeks, 12 weeks, and 6 months were pooled. The outcomes were current pain (NRS or VAS, 11 points scale), characteristic pain intensity, and subjective disability. A random effects meta-analysis model for continuous outcomes to display standardized mean differences between intervention and control was performed, followed by sensitivity multilevel meta-regressions. Overall, 2391 patients were randomized; 1976 (3 weeks, short-term), 1740 (12 weeks, intermediate), and 1560 (6 months, sustainability) participants were included in the meta-analyses. In the short-term, intermediate and sustainability, moderate-to-high quality evidence indicated that MCE has a larger effect on current pain (SMD = -0.15, -0.15, -0.19), pain intensity (SMD = -0.19, -0.26, -0.26) and disability (SMD = -0.15, -0.27, -0.25) compared with no exercise intervention. Low-quality evidence suggested that those patients with comparably intermediate current pain and older patients may profit the most from MCE. Motor control stabilisation exercise is an effective treatment for non-specific low back pain. Sub-clinical intermediate pain and middle-aged patients may profit the most from this intervention.

Trauma exposure, posttraumatic stress disorder and oxytocin: A meta-analytic investigation of endogenous concentrations and receptor genotype.

Oxytocin's stress-reducing and social functions suggest an involvement in trauma processing and posttraumatic stress disorder (PTSD). We searched PubMed, PubPsych, PsycINFO, PsycARTICLES, Web of Science, ProQuest and ClinicalTrials.gov for studies assessing endogenous oxytocin, oxytocin receptor genotype or methylation in traumatized humans. Eligible studies (k = 66) were systematically described. We meta-analytically compared oxytocin parameters between traumatized and non-traumatized individuals (k = 17) and individuals with and without PTSD (k = 8), and correlated oxytocin with trauma exposure (k = 16) and PTSD symptoms (k = 8). Endogenous oxytocin concentrations did not differ between PTSD patients and healthy individuals. The remaining effects on endogenous oxytocin were heterogeneous. Subgroup analyses identified sampling-related, trauma-related and demographic moderators, resulting in inconsistent or non-significant effects. Methylation data were insufficient for meta-analyses, and meta-analytic genotype results were inconsistent. Unstimulated endogenous oxytocin was not a biomarker for trauma exposure or PTSD. Given the impact of methodology, more basic research on endogenous oxytocin measurements is needed. Future studies might consider the oxytocin stress response and investigate oxytocin longitudinally.

Effectiveness of an Attachment-Informed Working Alliance in Interdisciplinary Pain Therapy.

Attachment theory provides a useful framework for understanding individual differences in pain patients, especially with insecure attachment shown to be more prevalent in chronic pain patients compared to the general population. Nevertheless, there is little evidence of attachment-informed treatment approaches for this population. The present study compares outcomes from two different attachment-informed treatment modalities for clinicians, with outcomes from treatment as usual (TAU). In both intervention groups (IG1 and IG2), clinicians received bi-monthly training sessions on attachment. Additionally, clinicians in IG1 had access to the attachment diagnostics of their patients. All treatments lasted for four weeks and included a 6-month follow up. A total of 374 chronic pain patients were recruited to participate in this study (TAU = 159/IG1 = 163/IG2 = 52). Analyses were carried out using multilevel modeling with pain intensity as the outcome variable. Additionally, working alliance was tested as a mediator of treatment efficacy. The study was registered under the trial number DRKS00008715 on the German Clinical Trials Register (DRKS). Findings show that while IG2 was efficient in enhancing treatment outcomes, IG1 did not outperform TAU. In IG2, working alliance was a mediator of outcome. Results of the present study indicate that attachment-informed treatment of chronic pain can enhance existing interdisciplinary pain therapies; however, caveats are discussed.

Impact of attachment behavior on the treatment process of chronic pain patients.

BACKGROUND: Insecure attachment patterns are related to the onset and development of chronic pain. However, it is less documented on how short- and long-term effects of pain therapy might differ with the attachment style in interaction with specific pain conditions. We therefore examined how two different groups of chronic pain patients differ in their treatment trajectories and in regard to attachment. METHOD: N=85/76/67 (T1/T2/T3) patients with medically unexplained musculoskeletal pain (UMP group) were compared to n=89/76/56 patients with joint pain from osteoarthritis (OA group), using multilevel modeling. UMP patients received a multimodal pain program, and OA patients received surgery. Pain intensity before (T1) and after (T2) treatment and at a 6 months follow-up (T3) was assessed by using a visual analog scale of pain. RESULTS: Pain patients report a significant reduction in pain intensity upon the completion of the treatment compared to T1. Over the next 6 months, the pain intensity has further declined for patients with low attachment anxiety. In contrast, patients with highly anxious attachment report an increase in pain intensity. This main effect of anxious attachment on pain is significant when predicting changes both in acute treatment and during follow-up while controlling for group effect. In addition, there is also an interactive effect of group by avoidant attachment. In the UMP group, high scores in avoidant attachment were associated with the lower reduction in pain severity, while in the OA group, high scores in attachment avoidance were associated with a steeper reduction in pain severity. CONCLUSION: The results indicate that insecurely attached patients with pain symptoms only benefit from a multimodal pain therapy in limited ways in regard to posttreatment trajectories. Maintaining positive results over a period of 6 months is a challenge, compared with securely attached patients. SIGNIFICANCE: The results of this study suggest the importance of direct and indirect mechanisms of attachment and its relevance for the management of pain experiences. Therefore, to include the individual attachment patterns in the treatment may be a promising way to enhance the treatment prospects.

Medicine in spine exercise (MiSpEx) for nonspecific low back pain patients: study protocol for a multicentre, single-blind randomized controlled trial.

BACKGROUND: Arising from the relevance of sensorimotor training in the therapy of nonspecific low back pain patients and from the value of individualized therapy, the present trial aims to test the feasibility and efficacy of individualized sensorimotor training interventions in patients suffering from nonspecific low back pain. METHODS AND STUDY DESIGN: A multicentre, single-blind two-armed randomized controlled trial to evaluate the effects of a 12-week (3 weeks supervised centre-based and 9 weeks home-based) individualized sensorimotor exercise program is performed. The control group stays inactive during this period. Outcomes are pain, and pain-associated function as well as motor function in adults with nonspecific low back pain. Each participant is scheduled to five measurement dates: baseline (M1), following centre-based training (M2), following home-based training (M3) and at two follow-up time points 6 months (M4) and 12 months (M5) after M1. All investigations and the assessment of the primary and secondary outcomes are performed in a standardized order: questionnaires - clinical examination - biomechanics (motor function). Subsequent statistical procedures are executed after the examination of underlying assumptions for parametric or rather non-parametric testing. DISCUSSION: The results and practical relevance of the study will be of clinical and practical relevance not only for researchers and policy makers but also for the general population suffering from nonspecific low back pain. TRIAL REGISTRATION: Identification number DRKS00010129. German Clinical Trial registered on 3 March 2016.

Study protocol - efficacy of an attachment-based working alliance in the multimodal pain treatment.

BACKGROUND: The concept of attachment is relevant for the onset and development of chronic pain. Insecure attachment styles negatively affect therapeutic outcome. Insecurely attached patients seem to be less able to sustain positive effects of a multimodal treatment program. However, it has never been tested before if an attachment-oriented approach can improve treatment results of insecurely attached patients in a multimodal outpatient setting. To test this assumption, we compare the short- and long-term outcomes for pain patients who will receive multidisciplinary, attachment-oriented treatment with the outcomes for patients in a control group, who will receive the multidisciplinary state-of-the-art treatment. METHODS: Two patient groups (baseline, attachment intervention) are assessed before treatment, after treatment, and at a 6 month follow-up. The study is conducted in a block design: After data collection of the first block (controls) and before as well as during data collection for the second block (treatment group), the health care personnel of the outpatient pain clinic receives training on attachment theory and its use in the therapeutic context. Pain intensity as measured with visual analogue scales and physical functioning will serve as the primary outcome measures. DISCUSSION: The design of our study allows for a continuous exchange of experienced team members, which may help bring about concrete attachment related guidelines for the enhancement of therapeutic outcome. This would be the first attempt at an attachment-oriented improvement of multimodal pain programs. CONCLUSION: An attachment-based approach may be a promising way to enhance long-term treatment outcomes for insecurely attached pain patients. TRIAL REGISTRATION: DRKS00008715 (registered on the 3(rd) of June 2015).