Abstract
SummaryExtracorporeal shockwave therapy showed a pronounced effect on bone mass in previous animal studies. We showed in this pilot study that a single treatment with unfocused shockwave therapy in unselected patients does not show side effects. Although our study did not show any effect of shockwave on BMD, the limited sample size does not definitively exclude this and a study with 174 subjects per group would be needed to show an effect size of 0.3 with a power of 80%.PurposeUnfocused extracorporeal shockwave therapy might stimulate bone formation to reduce the fracture risk. In this study, we assessed the safety of unfocused extracorporeal shockwave therapy and its effects on bone mass.MethodsA clinical pilot study with twelve female patients free of bone disease undergoing elective surgery of the lower extremity or elective spinal surgery under general anesthesia received 3.000 electrohydraulic-generated unfocused extracorporeal shockwaves (energy flux density 0.3 mJ/mm2) to one distal forearm. The contralateral forearm served as a control. We examined the effect on bone mass with the use of repeated dual energy X-ray absorptiometry measurements and we measured patient discomfort around the therapy.ResultsNo difference in bone mineral content and density was measured 6 and 12 weeks after therapy. shockwave therapy occasionally caused transient erythema or mild hematoma, but no discomfort in daily life or (late) adverse events.ConclusionsUnfocused extracorporeal shockwave therapy is a safe treatment, but no increase in bone mass on the forearm was found at 0.3 mJ/mm2 energy flux density. In this study, we were not able to demonstrate that a single treatment with unfocused shockwave therapy in unselected patients had any effect in terms of bone mineral density (BMD) or bone mineral content (BMC). A power analysis indicated that 174 patients per group are required to show an effect size of 0.3 with a power of 80%.
Highlights
Osteoporosis is a disease characterized by bone loss and deterioration of the bone micro architecture, leading to a higher susceptibility for fractures
In the search for an alternative, preferably anabolic therapy, we examined the application of extracorporeal shockwaves (ESW), which showed a pronounced effect on bone mass, leading to relatively early improved biomechanical properties in previous studies in the rat tibia [8,9,10,11]
When bone density increase can be achieved at clinically relevant levels, this may be a non-invasive additive to today’s osteoporosis treatment or locally improve bone quality for better osteosynthesis
Summary
Osteoporosis is a disease characterized by bone loss and deterioration of the bone micro architecture, leading to a higher susceptibility for fractures. In the search for an alternative, preferably anabolic therapy, we examined the application of extracorporeal shockwaves (ESW), which showed a pronounced effect on bone mass, leading to relatively early improved biomechanical properties in previous studies in the rat tibia [8,9,10,11]. For the treatment of dermatologic pathologies, generators that produce unfocused shockwaves have been developed, which produce a parallel bundle, enabling a homogenous treatment of larger areas [19] Skeletal sites, such as the distal radius and proximal femur, are interesting candidates to examine, because they represent well-known locations of osteoporotic fractures and are easy to reach for shockwave therapy [20]. In the current clinical pilot study, the safety as well as potential magnitude and duration of the anabolic effects of unfocussed shockwave therapy is being assessed in the distal forearm of twelve patients
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