Spinal manipulative therapy, Graston technique® and placebo for non-specific thoracic spine pain: A randomised controlled trial

Abstract

Background: Few controlled trials have assessed the efficacy of spinal manipulative therapy (SMT) for thoracic spine pain. No high quality trials have been performed to test the efficacy and effectiveness of Graston Technique® (GT), an instrument-assisted soft tissue therapy. The objective of this trial was to determine the efficacy of SMT and GT compared to sham therapy for the treatment of non-specific thoracic spine pain. Methods: People with non-specific thoracic pain were randomly allocated to one of three groups: SMT, GT, or a placebo (de-tuned ultrasound). Each participant received up to 10 supervised treatment sessions at Murdoch University chiropractic student clinic over a 4 week period. The participants and treatment providers were not blinded to the treatment allocation as it was clear which therapy they were receiving, however outcome assessors were blinded and we attempted to blind the participants allocated to the placebo group. Treatment outcomes were measured at baseline, 1 week, and at one, three, six and 12 months. Primary outcome measures included a modified Oswestry Disability Index, and the Visual Analogue Scale (VAS). Treatment effects were estimated with intention to treat analysis and linear mixed models. Results: One hundred and forty three participants were randomly allocated to the three groups (SMT = 36, GT = 63 and Placebo = 44). Baseline data for the three groups did not show any meaningful differences. Results of the intention to treat analyses revealed no time by group interactions, indicating no statistically significant between-group differences in pain or disability at 1 week, 1 month, 3 months, 6 months, or 12 months. There were significant main effects of time (p < 0.01) indicating improvements in pain and disability from baseline among all participants regardless of intervention. No significant adverse events were reported. Conclusion: This study indicates that there is no difference in outcome at any time point for pain or disability when comparing SMT, Graston Technique® or sham therapy for thoracic spine pain, however all groups improved with time. These results constitute the first from a fully powered randomised controlled trial comparing SMT, Graston technique® and a placebo. Trial Registration: This trial was registered with the Australia and New Zealand Clinical Trials Registry on the 7th February, 2008. Trial number: ACTRN12608000070336