Effectiveness and mechanisms of a multimodal treatment for low back pain: a pragmatic matched cohort study

Abstract

Objective: To investigate the effectiveness and mechanisms of a multimodal treatment including perturbation exercise directly applied in health care. Methods: A pragmatic, matched cohort study was conducted. Participants from the intervention group had chronic or recurrent low back pain and participated in a 12-week back pain prevention program. Coaches were trained to deliver multimodal care. Controls (usual care) were matched from a multi-center RCT. Outcomes were pain, disability, isokinetic trunk strength (extension/flexion) and balance (center of pressure trace). A Bayesian, sequential analysis along 8 matching procedures and moderation/mediation analyses incorporating the biopsychological avoidance-endurance model were conducted. Median values with highest posterior density intervals (HPDI) from baseline-adjusted analyses are presented. Results: Over 12 weeks, intervention and control experienced a similar decrease in pain and disability, which led to negligible average treatment effects for pain (0.5 HPDI95% [-3.6; 4.6]) and disability (1.5 HPDI95% [-2.3; 5.4]) for the intervention. Changes in functional strength and balance showed small but favorable effects for the intervention group, in particular for trunk extension (-4.1 Nm HPDI95% [-18.2, 10.0]) and monopedal stances (standardized score: 0.49 HPDI95% [0.13, 0.79]). Depression was higher in drop-outs and decreases in pain and disability were associated with decreases in depression. Distress-endurance subgroups experienced higher baseline pain and disability and showed the highest reductions in both parameters upon completion of the intervention. Conclusion: Multimodal treatments for low back pain without tailoring are possibly less effective in the context of health care than their efficacy in RCTs suggests. Targeting distress-endurance subgroups with a multimodal treatment approach is probably an effective strategy in treatment tailoring.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

Intervention: DRKS00030389, Control: DRKS00010129

Funding Statement

This study was conducted within the MiSpEx research network and funded by the German Federal.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study was approved by the local ethics committee of the Faculty of Sport Science of Ruhr-University Bochum (EKS V 10/2017).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

Data of the treatment group, study documents and the analysis script are available in our online repository.

https://osf.io/mbrh

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