Question Is a heatwrap combined with exercise more effective in improving symptoms and functional outcomes on short- mid- and long-term than either a heatwrap alone or a sham heatwrap in acute low back pain?

Design A multi-arm randomised controlled trial.

Participants Adults aged 18 to 65 years with a new episode of low back pain (defined as pain for six weeks or less with no low back pain in the three months preceding the current episode).

Intervention Participants were randomly assigned to one of three groups: heatwrap plus exercise (n=34), heatwrap alone (n=33) or sham heatwrap (n=32). All participants were asked to wear the heatwrap eight hours per day for seven days. The exercise group had to perform exercises 30 minutes per day for five days. All participants received evidence-based advice for the management of their pain.

Outcome measures Our primary outcome was pain-related disability at one week measured with the Oswestry Disability Index. Our secondary outcomes were pain intensity, pain-related fear of movement, self-efficacy, pain catastrophizing and perception of change. Outcomes were measured at baseline and at 1, 4, 12, 26 and 52 weeks.

Data analysis We used linear mixed models (LMMs) to compare intervention efficacy on all outcomes at all time-points with intention-to-treat analyses, testing the Group x Time interaction.

Results The analysis included 99 participants. The results for pain-related disability showed no Group x Time interaction (F=0.467; p=0.910), but a statistically significant time effect was observed (F=39.843; p<0.001) as scores decreased for all groups at one week, with an estimated mean difference of −7.8 (95% CI −9.7 to −5.9). All outcomes showed a time effect at all time-points.

Conclusion A combination of heatwrap and exercise did not provide a superior effect on symptoms and functional outcomes on short-, mid and long-term when compared to a heatwrap alone and a sham heatwrap in adults with acute low back pain. Future guidelines should consider these results to formulate recommendations for acute LBP.

Trial registration: ClinicalTrials.gov Identifier: NCT03986047

The authors have declared no competing interest.

NCT03986047

https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-020-03829-7

This study was funded by the Quebec Pain Research Network.

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 received ethical approval from the Research Ethics Committee of the CIUSSS de la Capitale-Nationale (#2019-1731, RIS, CER CIUSSS-CN)

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Yes

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All data produced in the present study are available upon reasonable request to the authors