Dataset Information

Back to living well: community-based management of low back pain: a feasibility study.

ABSTRACT:

Background

Low back pain (LBP) is a long-term health condition with an unpredictable pattern of symptomatic episodes, remission, and recurrence. Recently published systematic reviews suggest that exercise is the most effective intervention for preventing recurrences of LBP in persons that have recovered. Similar programs may also be effective in preventing flare-ups in persistent LBP. The aim of this study was to test the feasibility of the Back to Living Well program (Physical activity + Education + Self-management) developed to prevent recurrence or flare-ups of LBP. The study evaluated feasibility in terms of recruitment rate, adherence, satisfaction with the exercise and education sessions, and the data collection procedures. We also aimed to evaluate barriers and facilitators to the engagement in the program.

Methods

Seventeen participants with non-specific LBP recently discharged from care from physiotherapy, chiropractors or physician care (< 3 months) were referred to the study by health care providers or community advertisements between December 2018 and February 2019. Participants underwent a 12-week (1 session/week) individualized, group-based exercise in the community and 4 sessions (30 min each) of education. All participants completed an action plan weekly for 12 weeks and wore an activity monitor for 6 months. All participants responded to weekly pain measures and completed study questionnaires at baseline, 3- and 6-months. Feasibility outcomes included recruitment, attrition rates and satisfaction. At the end of the intervention, participants completed an end-of-program survey.

Results

Twenty-nine participants were screened for eligibility; 20 were deemed eligible, while 17 were included over a 2-month period meeting our feasibility targets. In total, 16 completed follow-up study questionnaires at 3 months, and 15 completed the 6-month follow-up. Fourteen participants responded to weekly messages, while 3 participants reported not having a mobile device or Internet access. In total, 15 participants responded to our end-of-program survey. Average age was 54.9 (11.7); 9 were female (53%), and the mean duration of LBP was 62.9 (69.7) months. All satisfaction responses in relation to the exercise program, education program and data collection procedures reached our threshold of 70% out of 100%. Reported barriers to engagement in the program included fear of injury, lack of motivation and travel. Facilitators included proximity to home, low cost, flexible schedule and friendly location.

Conclusion

The results show the program is feasible in terms of recruitment, low attrition, and patient satisfaction. Participants highlighted the excellent, relevant education program and the positive, personalized exercise. Future studies should evaluate the effectiveness of this intervention within a fully powered randomized controlled trial.

Trial registration

NCT03328689.

SUBMITTER: Macedo LG

PROVIDER: S-EPMC8223312 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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 can lead to individual suffering, high medical expenditures, and impaired social well-being. Although the role of physical activity in pain management is well established, the underlying mechanisms of biological and clinical outcomes are unknown. This study aimed to assess the feasibility and acceptability of a pain self-management intervention, Problem-Solving Pain to Enhance Living Well, which employs wearable activity tracking technology and nurse consultations for people with chronic low back pain.MethodsThis one-arm longitudinal study recruited 40 adults aged 18-60 years with chronic low back pain. Over 12 weeks, participants watched 10 short video modules, wore activity trackers, and participated in nurse consultations every 2 weeks. At baseline and the 12-week follow-up, they completed study questionnaires, quantitative sensory testing, and blood sample collection.ResultsForty participants were recruited, and their mean age was 29.8. Thirty-two participants completed the survey questionnaire, quantitative sensory testing, Fitbit activity tracker, and bi-weekly nurse consultation, and 25 completed the evaluation of biological markers. The overall satisfaction with the Problem-Solving Pain to Enhance Living Well video modules, nurse consultations, and Fitbit in pain management was rated as excellent. No adverse events were reported. Between the baseline and 12-week follow-up, there was a significant decrease in pain intensity and interference and an increase in the warm detection threshold at the pain site.ConclusionsDespite concerns about the participant burden due to multidimensional assessment and intensive education, the feasibility of the Problem-Solving Pain to Enhance Living Well intervention was favorable. Technology-based self-management interventions can offer personalized strategies by integrating pain phenotypes, genetic markers, and physical activity types affecting pain conditions.Trial registrationThis pilot study was registered with ClinicalTrials.gov [NCT03637998, August 20, 2018]. The first participant was enrolled on September 21, 2018.

Project description:IntroductionSelf-reported levels of disability in individuals with low back pain (LBP) have not improved in the last decade. A broader perspective and a more comprehensive management framework may improve disability outcomes. We recently developed and validated the Low Back Pain and Disability Drivers Management (PDDM) model, which aims to identify the domains driving pain and disability to guide clinical decisions. The objectives of this study were to determine the applicability of the PDDM model to a LBP population and the feasibility of conducting a pragmatic trial, as well as to explore clinicians' perceived acceptability of the PDDM model's use in clinical settings.MethodsThis study was an one-arm prospective feasibility trial. Participants included physiotherapists working with a population suffering from LBP and their patients aged 18 years or older presenting with a primary complaint of LBP that sought a new referral and deemed fit for rehabilitation from private and public clinical settings. Clinicians participated in a one-day workshop on the integration of the PDDM model into their clinical practice, and were asked to report various LBP-related outcomes via self-reported questionnaires (i.e., impact of pain on physical function, nervous system dysfunctions, cognitive-emotional factors, work disabilities) at baseline and at six-week follow-up. Physiotherapists' acceptability of the use of the PDDM model and appreciation of the training were assessed via semi-structured phone interviews. Analyses focused on a description of the model's applicability to a LBP population, feasibility outcomes and acceptability measures.ResultsApplicablity of the PDDM model was confirmed since it successfully established the profile of patients according to the elements of each categories, and each of the 5 domains of the model was represented among the study sample. Trial was deemed feasible contingent upon few modifications as our predefined success criteria for the feasibility outcomes were met but feasibility issues pertaining to data collection were highlighted. Twenty-four (24) clinicians and 61 patients were recruited within the study's timeframe. Patient's attrition rate (29%) and clinicians' compliance to the study protocol were adequate. Clinicians' perceived acceptability of the use of the model in clinical settings and their appreciation of the training and online resources were both positive. Recommendations to improve the model's integration in clinical practice, content of the workshop and feasibility of data collection methods were identified for future studies. A positive effect for all patients' reported outcome measures were also observed. All outcome measures except for the PainDetect questionnaire showed a statistically significant reduction post-intervention (p<0.05).ConclusionThese findings provide preliminary evidence of the potential of the PDDM model to optimize LBP management as well as conducting a future larger-scale pragmatic trial to determine its effectiveness.Trial registrationClinicaltrial.gov: NCT03949179.

Project description:BACKGROUND:People with low back pain (LBP) in the community often do not receive evidence-based advice and management. Community pharmacists can play an important role in supporting people with LBP as pharmacists are easily accessible to provide first-line care. However, previous research suggests that pharmacists may not consistently deliver advice that is concordant with guideline recommendations and may demonstrate difficulty determining which patients require prompt medical review. A clinical decision support system (CDSS) may enhance first-line care of LBP, but none exists to support the community pharmacist-client consultation. OBJECTIVE:This study aimed to develop a CDSS to guide first-line care of LBP in the community pharmacy setting and to evaluate the pharmacist-reported usability and acceptance of the prototype system. METHODS:A cross-platform Web app for the Apple iPad was developed in conjunction with academic and clinical experts using an iterative user-centered design process during interface design, clinical reasoning, program development, and evaluation. The CDSS was evaluated via one-to-one user-testing with 5 community pharmacists (5 case vignettes each). Data were collected via video recording, screen capture, survey instrument (system usability scale), and direct observation. RESULTS:Pharmacists' agreement with CDSS-generated self-care recommendations was 90% (18/20), with medicines recommendations was 100% (25/25), and with referral advice was 88% (22/25; total 70 recommendations). Pharmacists expressed uncertainty when screening for serious pathology in 40% (10/25) of cases. Pharmacists requested more direction from the CDSS in relation to automated prompts for user input and page navigation. Overall system usability was rated as excellent (mean score 92/100, SD 6.5; 90th percentile compared with similar systems), with acceptance rated as good to excellent. CONCLUSIONS:A novel CDSS (high-fidelity prototype) to enhance pharmacist care of LBP was developed, underpinned by clinical practice guidelines and informed by a multidisciplinary team of experts. User-testing revealed a high level of usability and acceptance of the prototype system, with suggestions to improve interface prompts and information delivery. The small study sample limits the generalizability of the findings but offers important insights to inform the next stage of system development.

Project description:OBJECTIVES:The aims of this study were to: (1) develop pain education materials in Nepali and (2) determine the feasibility of conducting a randomised clinical trial (RCT) of a pain education intervention using these materials in Nepal. DESIGN:A two-arm, parallel, assessor-blinded, feasibility RCT. SETTING:A rehabilitation hospital in Kathmandu, Nepal. PARTICIPANTS:Forty Nepalese with non-specific low back pain (mean [SD] age 41 [14] years; 12 [30%] women). INTERVENTIONS:Eligible participants were randomised, by concealed, 1:1 allocation, to one of two groups: (1) a pain education intervention and (2) a guideline-based physiotherapy active control group intervention. Each intervention was delivered by a physiotherapist in a single, 1-hour, individualised treatment session. PRIMARY OUTCOME MEASURES:The primary outcomes were related to feasibility: recruitment, retention and treatment adherence of participants, feasibility and blinding of outcome assessments, fidelity of treatment delivery, credibility of, and satisfaction with, treatment. Assessments were performed at baseline and at 1 week post-treatment. SECONDARY OUTCOME MEASURES:Pain intensity, pain interference, pain catastrophising, sleep disturbance, resilience, global rating of change, depression and quality of life. Statistical analyses were conducted blind to group allocation. RESULTS:Forty participants were recruited. Thirty-eight participants (95%) completed the 1-week post-treatment assessment. Most primary outcomes surpassed the a priori thresholds for feasibility. Several findings have important implications for designing a full trial. Secondary analyses suggest clinical benefit of pain education over the control intervention, with larger decrease in pain intensity (mean difference=3.56 [95% CI 0.21 to 6.91]) and pain catastrophising (mean difference=6.16 [95% CI 0.59 to 11.72]) in the pain education group. Pain intensity would seem an appropriate outcome for a full clinical trial. One minor adverse event was reported. CONCLUSION:We conclude that a full RCT of pain education for back pain in Nepal is feasible and warranted. TRIAL REGISTRATION NUMBER:NCT03387228; Results.

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