Abstract
Background
Shockwave therapy has been shown to induce osteoneogenesis in animal models. The mechanism of action is unclear, but experimental evidence suggests micro-fracture formation and increased blood flow as the most likely explanation. Several reports from Europe have suggested good results from the treatment of delayed fracture union with shock-waves. We present the results of a randomised double-blind placebo-controlled pilot study.
Method
Fourteen patients with clinically and radiologically confirmed delayed union of long-bones consented to enter the trial. The treatment group had a single application of 3000 high-energy shockwaves using the Stortz SLK unit with image intensifier control. The control group had the exactly the same treatment but with an ‘air-gap’ interposition to create a placebo-shockwave. Each patient was followed-up with serial radiographs as well as visual analogue pain scores and EuroQol assessments. All of the patients were reviewed for a minimum of three years post treatment.
Results
There was no difference between the groups in terms of time to fracture union (p=0.781 log-rank test). Nor was there any indication of a treatment effect on any of the secondary outcome measures.
Conclusion
We have been unable to recreate the previously reported favourable results of shockwave therapy in the treatment of delayed fracture union. On the basis of this study we have withdrawn a proposal for a multi-centre RCT.
