Abstract
Background
The available treatments for NSLBP (Non-Specific Low Back Pain) provide, typically, small to moderate average benefits to patients. The aim of this pilot cluster RCT was to test the hypothesis that the use of a patient decision aid together with an informed shared decision making consultation would produce better outcomes in satisfaction with treatment at four month follow-up.
Methods
We developed a DSP (Decision Support Package). We randomised the physiotherapists and trained those in the intervention arm in informed shared decision making and communication. Participants were recruited from a local physiotherapy department and those allocated to an appointment with an intervention therapist were sent a copy of the DSP in the post. Participants then attended their appointment as usual.
Results
We recruited 148 participants, 85 (57%) participants were assigned to the DSP arm. There was an 80% response rate for the primary outcome, satisfaction with treatment. The adjusted odds ratio of satisfaction with treatments from participants in the DSP arm against those in the control arm was 0.54 (95% CI: 0.19, 1.53). The difference between the treatment arms for the RMDQ (Roland Morris Disability Questionnaire) at four month follow-up was −2.27 (95% CI: −4.47, −0.08).
Conclusions
There were no differences in our primary outcome measure between the groups. There was a statistically significant and clinically important difference in the RMDQ. These data have informed our decision about progression to a full trial application.