Background The McKenzie Method of Mechanical Diagnosis and Therapy (MDT) is one of the exercise approaches recommended by low back pain (LBP) guidelines. We investigated the efficacy of MDT compared with placebo in patients with chronic LBP.
Methods This was a prospectively registered, two-arm randomised placebo controlled trial, with a blinded assessor. A total of 148 patients seeking care for chronic LBP were randomly allocated to either MDT (n=74) or placebo (n=74). Patients from both groups received 10 treatment sessions over 5 weeks. Patients from both groups also received an educational booklet. Clinical outcomes were obtained at the end of treatment (5 weeks) and 3, 6 and 12 months after randomisation. Primary outcomes were pain intensity and disability at the end of treatment (5 weeks). We also conducted a subgroup analysis to identify potential treatment effect modifiers that could predict a better response to MDT treatment.
Results The MDT group had greater improvements in pain intensity at the end of treatment (mean difference (MD) −1.00, 95% CI −2.09 to −0.01) but not for disability (MD −0.84, 95% CI −2.62 to 0.93). We did not detect between-group differences for any secondary outcomes, nor were any treatment effect modifiers identified. Patients did not report any adverse events.
Conclusion We found a small and likely not clinically relevant difference in pain intensity favouring the MDT method immediately at the end of 5 weeks of treatment but not for disability. No other difference was found for any of the primary or secondary outcomes at any follow-up times.
Trial registration number ClinicalTrials.gov (NCT02123394)
- Low back pain
- McKenzie method
- placebo method
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Contributors ANG was involved in setting the research question; trial design; literature search, writing protocol; data analysis and manuscript preparation assisted by LOPC, MJH and LdCMC. LOPC also contributed in securing funding assistance; randomisation schedule preparation; data interpretation and statistical analysis strategy. MJH also contributed to data interpretation and statistical analysis strategy. FSdS was the blind assessor and had full access to all of the data in the study. MOdA and GVFdOG were the therapists of placebo group. ANG was responsible for MDT treatment group. All coauthors reviewed the manuscript before submission.
Funding This work was funded by São Paulo Research Foundation (FAPESP). ANG had her PhD scholarship supported by Coordination for the Improvement of Higher Education Personnel (CAPES).
Competing interests The care provider who treated patients in the MDT group has completed first level McKenzie training, however has no involvement with the McKenzie Institute. This trial did not receive neither funding from McKenzie Institute nor any assistance in writing/analysing the results of this trial. Authors do not have any involvement with the McKenzie Institute. MJH, LOPC and ANG receive funding from International Mechanical Diagnosis and Therapy Research Foundation for the following studies on MDT: (1) Hancock MJ, Maher CG, Mota da Silva T, Clare H, Steffens D (2016). Secondary prevention of a recurrence of low back pain. (2) Hancock MJ, Garcia AN, Costa LdCM, Costa LOP (2014). Identifying patients with back pain who respond best to MDT. MJH is keynote speaker at the 2017 McKenzie conference and his travel costs will be paid.
Provenance and peer review Not commissioned; externally peer reviewed.