Dataset Information

Back Pain Consortium (BACPAC): Protocol and Pilot Study Results for a Randomized Comparative-Effectiveness Trial of Antidepressants, Fear Avoidance Rehabilitation, or the Combination for Chronic Low Back Pain and Comorbid High Negative Affect.

ABSTRACT:

Objective

Patients with chronic low back pain (CLBP) and comorbid depression or anxiety disorders are highly prevalent. Negative affect (NA) refers to a combination of negative thoughts, emotions, and behaviors. Patients with CLBP with high NA have greater pain, worse treatment outcomes, and greater prescription opioid misuse. We present the protocol for SYNNAPTIC (SYNergizing Negative Affect & Pain Treatment In Chronic pain).

Design

A randomized comparative-effectiveness study of antidepressants, fear-avoidance rehabilitation, or their combination in 300 patients with CLBP with high NA. In the antidepressant- or rehabilitation-only arms, SYNNAPTIC includes an adaptive design of re-randomization after 4 months for nonresponders.

Setting

A multisite trial conducted in routine pain clinical treatment settings: pain clinics and physical and occupational therapy treatment centers.

Methods

Inclusion criteria include CLBP with elevated depression and anxiety symptoms. Antidepressant and rehabilitation treatments follow validated and effective protocols for musculoskeletal pain in patients with high NA. Power and sample size are based on superior outcomes of combination therapy with these same treatments in a 71-subject 4-arm pilot randomized controlled trial.

Conclusions

SYNNAPTIC addresses the lack of evidence-based protocols for the treatment of the vulnerable subgroup of patients with CLBP and high NA. We hypothesize that combination therapy of antidepressants plus fear-avoidance rehabilitation will be more effective than each treatment alone.

Trial registration

ClinicalTrials.gov ID: NCT04747314.

SUBMITTER: Wasan AD

PROVIDER: S-EPMC10403304 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Back Pain Consortium (BACPAC): Protocol and Pilot Study Results for a Randomized Comparative-Effectiveness Trial of Antidepressants, Fear Avoidance Rehabilitation, or the Combination for Chronic Low Back Pain and Comorbid High Negative Affect.

Wasan Ajay D AD Edwards Robert R RR Kraemer Kevin L KL Jeong Jong J Kenney Megan M Luong Kevin K Cornelius Marise C MC Mickles Caitlin C Dharmaraj Bhagya B Sharif Essa E Stoltenberg Anita A Emerick Trent T Karp Jordan F JF Bair Matt J MJ George Steven Z SZ Hooten William M WM

Pain medicine (Malden, Mass.) 20230801 Suppl 1

<h4>Objective</h4>Patients with chronic low back pain (CLBP) and comorbid depression or anxiety disorders are highly prevalent. Negative affect (NA) refers to a combination of negative thoughts, emotions, and behaviors. Patients with CLBP with high NA have greater pain, worse treatment outcomes, and greater prescription opioid misuse. We present the protocol for SYNNAPTIC (SYNergizing Negative Affect & Pain Treatment In Chronic pain).<h4>Design</h4>A randomized comparative-effectiveness study of ...[more]

PMID: 36715655

Similar Datasets

Project description:BackgroundChronic low back pain (cLBP) is a complex with a heterogenous clinical presentation. A better understanding of the factors that contribute to cLBP is needed for accurate diagnosis, optimal treatment, and identification of mechanistic targets for new therapies. The Back Pain Consortium (BACPAC) Research Program provides a unique opportunity in this regard, as it will generate large clinical datasets, including a diverse set of harmonized measurements. The Theoretical Model Working Group was established to guide BACPAC research and to organize new knowledge within a mechanistic framework. This article summarizes the initial work of the Theoretical Model Working Group. It includes a three-stage integration of expert opinion and an umbrella literature review of factors that affect cLBP severity and chronicity.MethodsDuring Stage 1, experts from across BACPAC established a taxonomy for risk and prognostic factors (RPFs) and preliminary graphical depictions. During Stage 2, a separate team conducted a literature review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to establish working definitions, associated data elements, and overall strength of evidence for identified RPFs. These were subsequently integrated with expert opinion during Stage 3.ResultsThe majority (∼80%) of RPFs had little strength-of-evidence confidence, whereas seven factors had substantial confidence for either a positive association with cLBP (pain-related anxiety, serum C-reactive protein, diabetes, and anticipatory/compensatory postural adjustments) or no association with cLBP (serum interleukin 1-beta / interleukin 6, transversus muscle morphology/activity, and quantitative sensory testing).ConclusionThis theoretical perspective will evolve over time as BACPAC investigators link empirical results to theory, challenge current ideas of the biopsychosocial model, and use a systems approach to develop tools and algorithms that disentangle the dynamic interactions among cLBP factors.

Project description:The purpose of this secondary analysis was to test the hypothesis that an empirically derived psychological subgrouping scheme based on multiple Fear-Avoidance Model (FAM) constructs would provide additional capabilities for clinical outcomes in comparison with a single FAM construct.Patients (n=108) with acute or subacute low back pain enrolled in a clinical trial comparing behavioral physical therapy interventions to classification-based physical therapy completed baseline questionnaires for Pain Catastrophizing Scale, fear-avoidance beliefs [Fear-Avoidance Beliefs Questionnaire (FABQ)-physical activity scale (PA), FABQ work scale], and patient-specific fear (Fear of Daily Activities Questionnaire). Clinical outcomes included pain intensity and disability measured at baseline, 4 weeks, and 6 months. A hierarchical agglomerative cluster analysis was used to create distinct cluster profiles among the FAM measures and discriminant analysis was used to interpret clusters. Changes in clinical outcomes were investigated with repeated measures analysis of variance and differences in results based on cluster membership were compared with FABQ-PA subgrouping used in the original trial.Three distinct FAM subgroups (Low-Risk, High Specific Fear, and High Fear and Catastrophizing) emerged from cluster analysis. Subgroups differed on baseline pain and disability (P<0.01) with the High Fear and Catastrophizing subgroup associated with greater pain than the Low-Risk subgroup (P<0.01) and the greatest disability (P<0.05). Subgroup×time interactions were detected for both pain and disability (P<0.05) with the High Fear and Catastrophizing subgroup reporting greater changes in pain and disability than other subgroups (P<0.05). In contrast, FABQ-PA subgroups used in the original trial were not associated with interactions for clinical outcomes.These data suggest that subgrouping based on multiple FAM measures may provide additional information on clinical outcomes in comparison with determining subgroup status by FABQ-PA alone. Subgrouping methods for patients with low back pain should include multiple psychological factors to further explore if patients can be matched with appropriate interventions.

Project description:BackgroundAntidepressants are commonly used in the management of low-back pain. However, their use is controversial.ObjectivesThe aim of this review was to determine whether antidepressants are more effective than placebo for the treatment of non-specific low-back pain.Search strategyRandomised controlled trials were identified from MEDLINE and EMBASE (to September 2007), PsycINFO to June 2006, the Cochrane Central Register of Controlled Trials 2006, issue 2, and previous systematic reviews.Selection criteriaWe included randomised controlled trials that compared antidepressant medication and placebo for patients with non-specific low-back pain, and used at least one clinically relevant outcome measure.Data collection and analysisTwo blinded review authors independently extracted data and assessed the methodological quality of the trials. Meta-analyses were used to examine the effect of antidepressants on pain, depression and function, and the effect of antidepressant type on pain. To account for studies that could not be pooled, additional qualitative analyses were performed using the levels of evidence recommended by the Cochrane Back Review Group.Main resultsTen trials that compared antidepressants with placebo were included in this review. The pooled analyses showed no difference in pain relief (six trials; standardized mean difference (SMD) -0.06 (95% confidence interval (CI) -0.28 to 0.16)) or depression (two trials; SMD 0.06 (95% CI -0.29 to 0.40)) between antidepressant and placebo treatments. The qualitative analyses found conflicting evidence on the effect of antidepressants on pain intensity in chronic low-back pain, and no clear evidence that antidepressants reduce depression in chronic low-back pain patients. Two pooled analyses showed no difference in pain relief between different types of antidepressants and placebo. Our findings were not altered by the sensitivity analyses which varied the level of methodological quality required for inclusion in the meta-analyses to allow data from additional trials to be examined. Two additional trials were identified in September 2007 and await assessment.Authors' conclusionsThere is no clear evidence that antidepressants are more effective than placebo in the management of patients with chronic low-back pain. These findings do not imply that severely depressed patients with back pain should not be treated with antidepressants; furthermore, there is evidence for their use in other forms of chronic pain.

Project description:Purpose:Physical dysfunction in chronic low back pain patients is influenced by psychological variables rather than by pain severity. Assessing personality traits may help clinicians address the complexity of patients' experiences and design treatments that target these vulnerabilities. This study aimed to identify the distinguishing personality traits of a cohort of patients with disabling chronic low back pain and to determine associations between those traits and fear-avoidance beliefs, depressive, and anxious moods. Patients and Methods:This cross-sectional study included 102 chronic low back pain patients (57% male), who failed standard management and were referred to a multidisciplinary rehabilitation program. All patients completed the five domains of the NEO Personality Inventory (NEO PI)-Revised (Neuroticism, Extraversion, Openness to experience, Agreeableness and Conscientiousness), the Tampa Scale for Kinesiophobia (TSK), and the Hospital Anxiety and Depression Scale (HADS). One-sample t-test was used to compare sample personality means with average population norms. Association between the five personality domains with TSK and HADS was assessed using Pearson's correlation, adjusted for patient demographics and pain-related variables. Linear regression was used to estimate associations adjusted for covariates. Results:Both men and women had significantly lower scores in the Openness to experience domain and significantly higher scores in the Conscientiousness domain than the general population norms. After adjusting for covariates, Neuroticism was associated with higher fear-avoidance, depression and anxiety scores. Conversely, Extraversion and Openness to experience negatively correlated with depression scores. Extraversion also inversely correlated with fear-avoidance. Conscientiousness negatively correlated with depression and anxiety after adjustment. Conclusion:Patients with disabling chronic low back pain show personality characteristics that deviate significantly from the normal population norms but do not reach maladaptive forms of personality disorders. Clinicians would benefit from assessing patients' personality traits to address protective and risk factors for psychological distress, particularly in difficult-to-treat, highly disabled low back pain patients.

Dataset Information

Back Pain Consortium (BACPAC): Protocol and Pilot Study Results for a Randomized Comparative-Effectiveness Trial of Antidepressants, Fear Avoidance Rehabilitation, or the Combination for Chronic Low Back Pain and Comorbid High Negative Affect.

Objective

Design

Setting

Methods

Conclusions

Trial registration

Publications

Back Pain Consortium (BACPAC): Protocol and Pilot Study Results for a Randomized Comparative-Effectiveness Trial of Antidepressants, Fear Avoidance Rehabilitation, or the Combination for Chronic Low Back Pain and Comorbid High Negative Affect.

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