Development of a booster intervention for graded sensorimotor retraining (RESOLVE) in people with persistent low back pain: A nested, randomised, feasibility trial.

INTRODUCTION: Low back pain contributes to an increasing global health burden exacerbated by unsustained improvements from current treatments. There is a need to develop, and test interventions to maintain initial improvements from low back pain treatments. One option is to implement a booster intervention. This study aimed to develop and test the feasibility of implementing a booster intervention delivered remotely to supplement the benefits from a complex intervention for chronic low back pain. METHOD: This study was nested in the RESOLVE trial. The booster intervention was developed by an expert group, including a clinical psychologist, exercise physiologist and physiotherapists, and based on a motivational interviewing framework. We developed a conversational flow chart to support the clinician to guide participants towards achieving their pre-specified personal goals and future low back pain self-management. Participants with chronic low back pain who were aged over 18 years and fluent in English were recruited. The booster intervention was delivered in one session, remotely, by telephone. The intervention was considered feasible if: participants were able to be contacted or <3 contacts were necessary to arrange the booster session; there were sufficient willing participants (<15% of sample unwilling to participate); and participants and research clinicians reported a perceived benefit of >7/10. RESULTS: Fifty participants with chronic non-specific low back pain were recruited to test the feasibility of implementing the booster intervention. Less than three contact attempts were necessary to arrange the booster session, only one participant declined to participate. Participants perceived the session to be beneficial; on a 0 to 10 scale of perceived benefit, the average score recorded was 8.3 (SD 2.0). Clinicians also reported a moderate perceived benefit to the participant; the average score recorded by clinicians was 6.3 (SD 1.6). CONCLUSION: We developed a step by step, simple booster intervention that was perceived to be beneficial to participants with chronic low back pain. The booster can feasibly be delivered remotely following a complex intervention.

Systematic reviews that include only published data may overestimate the effectiveness of analgesic medicines for low back pain: a systematic review and meta-analysis.

OBJECTIVE: Systematic reviews of analgesics for low back pain generally include published data only. Obtaining data from unpublished trials is potentially important because they may impact effect sizes in meta-analyses. We determined whether including unpublished data from trial registries changes the effect sizes in meta-analyses of analgesics for low back pain. STUDY DESIGN AND SETTING: Trial registries were searched for unpublished data that conformed to the inclusion criteria of n = 5 individual source systematic reviews. We reproduced the meta-analyses using data available from the original reviews and then reran the same analyses with the addition of new unpublished data. RESULTS: Sixteen completed, unpublished, trials were eligible for inclusion in four of the source reviews. Data were available for five trials. We updated the analyses for two of the source reviews. The addition of data from two trials reduced the effect size of muscle relaxants, compared with sham, for recent-onset low back pain from -21.71 (95% CI: -28.23 to -15.19) to -2.34 (95% CI: -3.34 to -1.34) on a 0-100 scale for pain intensity. The addition of data from three trials (one enriched design) reduced the effect size of opioid analgesics, compared with sham, for chronic low back pain from -10.10 (95% CI: -12.81 to -7.39) to -9.31 (95% CI: -11.51 to -7.11). The effect reduced in the subgroup of enriched design studies, from -12.40 (95% CI: -16.90 to -7.91) to -11.34 (95% CI: -15.36 to -7.32), and in the subgroup of nonenriched design studies, from -7.27 (95% CI: -9.97 to -4.57) to -7.19 (95% CI: -9.24 to -5.14). CONCLUSION: Systematic reviews should include reports of unpublished trials. The result for muscle relaxants conflicts with the conclusion of the published review and recent international guidelines. Adding unpublished data strengthens the evidence that opioid analgesics have small effects on persistent low back pain and more clearly suggests these effects may not be clinically meaningful.