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Evaluation and implementation of graded in vivo exposure for chronic low back pain in a German outpatient setting: a study protocol of a randomized controlled trial.

ABSTRACT: The purpose of the present study is to introduce an adapted protocol of in vivo exposure for fear avoidant back pain patients and its implementation in the German health care system without multidisciplinary teams. Case studies demonstrated promising effects but three preceding randomized controlled trials (RCTs) could not support the former results. More empirical support is necessary to further substantiate the effectiveness of in vivo exposure.A total of 108 chronic low back pain patients are randomly assigned to one out of three conditions (A: exposure_long (15 sessions), B: exposure_short (10 sessions) or C: control condition cognitive behavioral therapy (15 sessions)). The inclusion criteria are: back pain ?3 months and a sufficient level of fear-avoidance. An effect evaluation, a process evaluation and an economic evaluation are conducted. Primary outcomes are pain-related disability and pain intensity. Secondary outcomes are: emotional distress, fear avoidance, catastrophizing and costs. Data are collected at baseline, upon completion of the intervention, after 10 sessions, and at six months following completion of treatment. Besides the comparison of exposure in vivo and cognitive behavioral therapy (CBT), we additionally compare a short and a long version of exposure to analyze dose response effects.This is, to our knowledge, the first RCT comparing in vivo exposure to psychological treatment as usual in terms of cognitive behavioral therapy. Results will help to find out whether a tailored treatment for fear avoidant back pain patients is more effective than a general pain management treatment.The trial has been registered to ClinicalTrial.gov. The trial registration number is NCT01484418.

SUBMITTER: Riecke J

PROVIDER: S-EPMC3710494 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature

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Evaluation and implementation of graded in vivo exposure for chronic low back pain in a German outpatient setting: a study protocol of a randomized controlled trial.

Riecke Jenny J Holzapfel Sebastian S Rief Winfried W Glombiewski Julia Anna JA

Trials 20130709

<h4>Background</h4>The purpose of the present study is to introduce an adapted protocol of in vivo exposure for fear avoidant back pain patients and its implementation in the German health care system without multidisciplinary teams. Case studies demonstrated promising effects but three preceding randomized controlled trials (RCTs) could not support the former results. More empirical support is necessary to further substantiate the effectiveness of in vivo exposure.<h4>Methods</h4>A total of 108 ...[more]

PMID: 23837551

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Project description:Quasi-experimental clinical trial.This study compared outcomes from graded exercise and graded exposure activity prescriptions for patients participating in a multidisciplinary rehabilitation program for chronic low back pain. Our primary purpose was to investigate whether pain and disability outcomes differed based on treatment received (graded exercise or graded exposure). Our secondary purpose was to investigate if changes in selected psychological factors were associated with pain and disability outcomes.Behavioral interventions have been advocated for decreasing pain and disability from low back pain, yet relatively few comparative studies have been reported in the literature.Consecutive sample with chronic low back pain recruited over a 16-month period from an outpatient chronic pain clinic. Patients received physical therapy supplemented with either graded exercise (n=15) or graded exposure (n=18) principles. Graded exercise included general therapeutic activities and was progressed with a quota-based system. Graded exposure included specific activities that were feared due to back pain and was progressed with a hierarchical exposure paradigm. Psychological measures were pain-related fear (Fear-Avoidance Beliefs Questionnaire, Tampa Scale for Kinesiophobia, Fear of Pain Questionnaire), pain catastrophizing (Coping Strategies Questionnaire), and depressive symptoms (Beck Depression Inventory). Primary outcome measures were pain intensity (visual analog scale) and self-report of disability (modified Oswestry Disability Questionnaire).Statistically significant improvements (P<.01) were observed for pain intensity and disability at discharge. The rate of improvement did not differ based on behavioral intervention received (P>.05 for these comparisons). Overall, 50% of patients met criterion for minimally important change for pain intensity, while 30% met this criterion for disability. Change in depressive symptoms was associated with change in pain intensity, while change in pain catastrophizing was associated with change in disability.Physical therapy supplemented with graded exercise or graded exposure resulted in equivalent clinical outcomes for pain intensity and disability. The overall treatment effects were modest in this setting. Instead of being associated with a specific behavioral intervention, reductions in pain and disability were associated with reductions in depressive symptoms and pain catastrophizing, respectively.Therapy, level 2b–.

Project description:BackgroundPatient engagement in decisions regarding their health care may lead to improved outcomes and improved adherence to treatment plans. While there are several options for involving patients in their health care, goal setting is a readily accessible method for physical therapists to increase the involvement of patients in health care decisions. Physical therapy goals are often generated by health care providers based on subjective information or standardized, fixed-item, patient-reported outcome measures. However, these outcome measures may not fully reveal the activity and participation limitations of individual patients. Goal attainment scaling (GAS) is a patient-centered approach that allows patients to set meaningful goals. While GAS has been shown to be reliable, valid, and sensitive to change in various populations, there is limited evidence in the United States on utilizing GAS in physical therapy for patients with chronic low back pain (LBP).ObjectiveThe purpose of this paper is to describe the protocol for a study to (1) develop a way to apply GAS procedures for physical therapists treating patients with chronic LBP in the United States and (2) test the feasibility of applying GAS procedures for chronic LBP in an outpatient physical therapy setting.MethodsThis study used a mixed methods design with 2 phases: qualitative and quantitative. The qualitative phase of the study employed focus groups of patients with chronic LBP to identify an inventory of goals that were important and measurable. A series of prompts was developed from this inventory to assist physical therapists in collaboratively establishing goals with patients in a clinical setting. The quantitative phase of the study pilot-tested the inventory developed in the qualitative phase in patients with chronic LBP to determine feasibility, reliability, validity, and responsiveness. We also plan to compare how well GAS reveals change over time relative to traditional, fixed-item, patient-reported measures.ResultsPhase 1 data collection was completed in June 2020, while data collection for phase 2 was performed between March 2021 and December 2021. We anticipate that this study will demonstrate that GAS can be implemented successfully by outpatient physical therapists, and that it will demonstrate clinically important changes in patients with chronic LBP.ConclusionsGAS represents an opportunity for patient-centered care in the physical therapy management of chronic LBP. While GAS is not new, it has never been studied in real-world physical therapy for chronic LBP in a clinical setting. Due to unique time and productivity constraints, for GAS to be successfully implemented in this environment, we must demonstrate that clinicians can be trained efficiently and reliably, that GAS can be implemented in a clinical setting in under 15 minutes, and that GAS is able to detect clinically meaningful changes in patient outcomes.International registered report identifier (irrid)DERR1-10.2196/32457.

Project description:BackgroundThe current literature supports the effectiveness of exercise, education, and self-management interventions for the long-term management of persistent low back pain. However, there is significant uncertainty about the implementation of interventions related to barriers, facilitators, and patient's preferences. This study will evaluate the Back to Living Well program implementation from a participant and organizational perspective. More specifically we address the following objectives: 1) identify program barriers and facilitators from participants' perspectives, 2) identify factors related to program, personal and contextual factors that contribute to negative and positive outcomes, and outcome trajectories, 3) identify factors influencing participants' selection of an in-person or e-health program, and 4) evaluate program specific barriers and facilitators from the organization and care delivery perspectives.MethodsThis study will utilize a mixed-method convergent design including a longitudinal cohort strand and a longitudinal qualitative interview strand. The RE-AIM framework will be used to assess program implementation. Participants (n = 90, 1:1: in person or virtual) who choose to register in the program as well as staff (n = 10 to 15) involved in the delivery of the program will be invited to participate. Participants will participate in a 12-week physical activity, education, and self-management program. Implementation outcomes will be measured at 3-, 6-, 12-months, and six months after the end of the follow-ups. Interview scripts and directed content analysis will be constructed based on the Theoretical Domains Framework and the Neuromatrix Model of Pain, Theoretical Domains Framework. Staff interviews will be constructed and analyzed using the Consolidated Framework for Implementation Research. Participants will also complete pain, disability, quality of life and psychological questionnaires, wear an activity tracker at all time points, and complete weekly pain and activity limitation questions using a mobile application.DiscussionThe study results will provide evidence to inform potential future implementation of the program. An effective, appropriately targeted, and well implemented exercise program for the long-term management (i.e., tertiary prevention) of LBP could minimize the burden of the condition on patients, the health care system and society.Trial registrationClinicalTrials.gov NCT05929846. This (Registration Date: July 3 2023) study has been approved by the Hamilton Integrated Research Ethics Board Project ID#15,354.

Project description:BackgroundChronic low back pain (cLBP) can interfere with daily activities, and individuals with elevated pain-related fear (also known as kinesiophobia or the fear of injury due to movement) can develop worse long-term disability. Graded exposure (GEXP) protocols use successive participation in avoided activities to help individuals overcome fearful movement appraisals and encourage activity. We sought to develop a series of GEXP virtual reality (VR) walking and reaching scenarios to increase the exposure and engagement of people with high kinesiophobia and cLBP.ObjectiveThis study aims to (1) determine GEXP content validity of the VR application and (2) determine the feasibility of individuals with cLBP performing locomotion-enabled physical activities.MethodsWe recruited 13 individuals with cLBP and high pain-related fear to experience six VR modules, which provide progressive movement exposure over three sessions in a 1 week period. At session 1, participants ranked each module by likelihood to avoid and assigned an expected pain and concern for harming their back rating to each module. Participants provided a rating of perceived exertion (RPE) after experiencing each module. To test feasibility, we administered the system usability scale (SUS) and treatment evaluation inventory (TEI) following the final session. In addition, we measured pain and pain-related fear at baseline and follow-up.ResultsThe 12 participants who completed the study period assigned higher avoidance (P=.002), expected pain (P=.002), and expected concern (P=.002) for session 3 modules compared with session 1 modules. RPE significantly increased from session 1 (mean 14.8, SD 2.3) to session 3 (mean 16.8, SD 2.2; P=.009). The VR application showed positive feasibility for individuals with cLBP through acceptable SUS (mean 76.7, SD 13.0) and TEI (mean 32.5, SD 4.9) scores. Neither pain (P=.20) nor pain-related fear (P=.58) changed significantly across sessions.ConclusionsThe GEXP VR modules provided progressive exposure to physical challenges, and participants found the VR application acceptable and usable as a potential treatment option. Furthermore, the lack of significant change for pain and pain-related fear reflects that participants were able to complete the modules safely.

Project description:BackgroundPain is a prevalent and distressing symptom in patients with cancer, having an enormous impact on functioning and quality of life. Fragmentation of care, inadequate pain communication, and reluctance towards pain medication contribute to difficulties in optimizing outcomes. Integration of patient self-management and professional care by means of healthcare technology provides new opportunities in the outpatient setting.Methods/designThis study protocol outlines a two-armed multicenter randomized controlled trial that compares a technology based multicomponent self-management support intervention with care as usual and includes an effect, economic and process evaluation. Patients will be recruited consecutively via the outpatient oncology clinics and inpatient oncology wards of one academic hospital and one regional hospital in the south of the Netherlands. Irrespective of the stage of disease, patients are eligible when they are diagnosed with cancer and have uncontrolled moderate to severe cancer (treatment) related pain defined as NRS≥4 for more than two weeks. Randomization (1:1) will assign patients to either the intervention or control group; patients in the intervention group receive self-management support and patients in the control group receive care as usual. The intervention will be delivered by registered nurses specialized in pain and palliative care. Important components include monitoring of pain, adverse effects and medication as well as graphical feedback, education, and nurse support. Effect measurements for both groups will be carried out with questionnaires at baseline (T0), after 4 weeks (T1) and after 12 weeks (T2). Pain intensity and quality of life are the primary outcomes. Secondary outcomes include self-efficacy, knowledge, anxiety, depression and pain medication use. The final questionnaire contains also questions for the economic evaluation that includes both cost-effectiveness and cost-utility analysis. Data for the process evaluation will be gathered continuously over the study period and focus on recruitment, reach, dose delivered and dose received.DiscussionThe proposed study will provide insight into the effectiveness of the self-management support intervention delivered by nurses to outpatients with uncontrolled cancer pain. Study findings will be used to empower patients and health professionals to improve cancer pain control.Trial registrationNCT02333968 December 29, 2014.

Project description:IntroductionChronic 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.MethodsThe 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.ConclusionThis 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 registrationClinicalTrials.gov NCT05294081. Registered on 02 March 2022.

Project description:BackgroundReassuring patient education and exercise therapy are widely recommended interventions for back pain in clinical guidelines. However, many patients are offered non-guideline endorsed options, and strategies for effective implementation of guideline-based care have not yet been developed. This protocol outlines the evaluation of a strategy for nationwide implementation of standardised patient education and exercise therapy for people with persistent or recurrent back pain in a hybrid implementation-effectiveness design. The strategy and the evaluation were planned using the framework of the Behaviour Change Wheel.MethodsThe main activity of the implementation strategy is a two-days course for physiotherapists and chiropractors in delivering patient education and exercise therapy that is aimed at supporting patient self-management. This comes with ready-to-use patient education materials and exercise programs. The clinical intervention is a group-based program consisting of two sessions of patient education and 8 weeks of supervised exercises. The program uses a cognitive-behavioural approach and the aim of the exercise component is to restore the patient's ability and confidence to move freely. The implementation process is evaluated in a dynamic process monitoring the penetration, adoption and fidelity of the clinical intervention. The clinical intervention and potential effect mechanisms will be evaluated at the patient-level using measures of knowledge, skills, beliefs, performance, self-efficacy and success in self-management. The education of clinicians will be evaluated via clinician-level outcomes, including the Pain Attitudes and Beliefs Scale, the Practitioner Confidence Scale, and the Determinants of Implementation Behaviour Questionnaire. Effects at a national level will be investigated via data from national registries of health care utilisation and sick-leave.DiscussionThis implementation-effectiveness study is designed to evaluate the process of implementing an evidence-based intervention for back pain. It will inform the development of strategies for implementing evidence-based care for musculoskeletal pain conditions, it will enhance the understanding of mechanisms for developing patient self-management skills, and it will demonstrate the outcomes that are achievable in everyday clinical practice.Trial registrationClinicalTrials.gov NCT03570463 . Registered 27 June 2018.

Project description:BackgroundThe effectiveness of risk stratification for low back pain (LBP) management has not been demonstrated in outpatient physical therapy settings.ObjectiveThe purposes of this study were: (1) to assess implementation of a stratified care approach for LBP management by evaluating short-term treatment effects and (2) to determine feasibility of conducting a larger-scale study.DesignThis was a 2-phase, preliminary study.MethodsIn phase 1, clinicians were randomly assigned to receive standard (n=6) or stratified care (n=6) training. Stratified care training included 8 hours of content focusing on psychologically informed practice. Changes in LBP attitudes and beliefs were assessed using the Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT) and the Health Care Providers Pain and Impairment Relationship Scale (HC-PAIRS). In phase 2, clinicians receiving the stratified care training were instructed to incorporate those strategies in their practice and 4-week patient outcomes were collected using a numerical pain rating scale (NPRS), and the Oswestry Disability Index (ODI). Study feasibility was assessed to identify potential barriers for completion of a larger-scale study.ResultsIn phase 1, minimal changes were observed for PABS-PT and HC-PAIRS scores for standard care clinicians (Cohen d=0.00-0.28). Decreased biomedical (-4.5±2.5 points, d=1.08) and increased biopsychosocial (+5.5±2.0 points, d=2.86) treatment orientations were observed for stratified care clinicians, with these changes sustained 6 months later on the PABS-PT. In phase 2, patients receiving stratified care (n=67) had greater between-group improvements in NPRS (0.8 points; 95% confidence interval=0.1, 1.5; d=0.40) and ODI (8.9% points; 95% confidence interval=4.1, 13.6; d=0.76) scores compared with patients receiving standard physical therapy care (n=33).LimitationsIn phase 2, treatment was not randomly assigned, and therapist adherence to treatment recommendations was not monitored. This study was not adequately powered to conduct subgroup analyses.ConclusionsIn physical therapy settings, biomedical orientation can be modified, and risk-stratified care for LBP can be effectively implemented. Findings from this study can be used for planning of larger studies.

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Evaluation and implementation of graded in vivo exposure for chronic low back pain in a German outpatient setting: a study protocol of a randomized controlled trial.

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Evaluation and implementation of graded in vivo exposure for chronic low back pain in a German outpatient setting: a study protocol of a randomized controlled trial.

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