Garcia A N.1, Costa L M.1, Hancock M.2, Souza F.1, Gomes G.1, Almeida M.1, Costa L O.P.1,3
1Universidade Cidade de São Paulo, Masters and Doctoral Programs in Physical Therapy, São Paulo, Brazil, 2Macquarie University, Discipline of Physiotherapy, Faculty of Human Sciences, Sydney, Australia, 3The George Institute for Global Health, Musculoskeletal Division, Sydney, Australia
Background: Mechanical Diagnosis and Therapy (MDT) is recommended in guidelines to treat patients with chronic low back pain. This exercise method has never been compared to a placebo treatment.
Purpose: To assess the efficacy of MDT compared to placebo in patients with chronic low back pain.
Methods: This study was conducted in an outpatient physical therapy clinic. 148 patients seeking care for chronic low back pain were randomly allocated through a computer system to either MDT (n=74) or Placebo (n=74). The allocation was concealed. Patients from both groups also received an educational booklet. Clinical outcomes were obtained by a blinded assessor after treatment (10 sessions over a period of 5 weeks) and at 3, 6 and 12 months after randomisation. Primary outcomes were pain intensity (measured by the 010 pain numerical rating scale) and disability after treatment (measured by the 24-item Roland-Morris Disability Questionnaire). It was not possible to blind the therapists and patients to the conditions of treatment. Analysis was intention to treat and primary and secondary outcomes were analyzed using linear mixed models.
Results: The MDT group had greater improvements in pain intensity at 5 weeks; mean effect -1.00 point
(95% CI -2.09 to -0.01) but not for disability (-0.84 point, 95% CI -2.62 to 0.93). We did not detect between group differences for all secondary outcomes. Patients did not report any adverse events.
Conclusion(s): MDT method was slightly more effective than placebo for pain intensity after treatment, but not for pain at longer follow ups or for disability at any follow up, in patients with chronic low back pain.
Implications: This is the first trial to assess the efficacy of the MDT comparing with a placebo method in patients with chronic nonspecific low back pain at short, intermediate and long term follow up. This study provided precise estimates of treatment effects for pain but possibly doubtful clinical importance.
Funding acknowledgements: São Paulo Research Foundation - FAPESP (2013/20075-5) and Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES).
Topic: Musculoskeletal: spine
Ethics approval: Approved by the Research Ethics Committee of the Universidade Cidade de São Paulo (#480.754) and prospectively registered at ClinicalTrials.gov (NCT02123394).
All authors, affiliations and abstracts have been published as submitted.
