Effect of unfocused extracorporeal shockwave therapy on bone mineral content of twelve distal forearms of postmenopausal women: a clinical pilot study

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%.

Evaluation of treatment parameters for focused-extracorporeal shock wave therapy in knee osteoarthritis patients with bone marrow lesions: a pilot study

“…Likewise, a study by Shi et al ( 33 ) reported that a high-energy focused-ESWT (0.28 mJ/mm 2 EFD) treatment improved hip BMD in postmenopausal osteoporotic patients compared with low-energy (0.15 mJ/mm 2 EFD) and control at 1-year follow-up. On the contrary, 1 session of unfocussed-ESWT with 3000 shocks and 0.3 mJ/mm 2 EFD on the distal forearm of 12 postmenopausal female subjects, free of bone disease, demonstrated no effect on BMD ( 34 ).…”

Extracorporeal Shockwave Therapy in the Treatment of Nonunion in Long Bones: A Systematic Review and Meta-Analysis

“…However, the optimal energy regimen is still controversial. Koolen et al have shown that a single treatment with unfocused ESW of 0.3 mJ/mm 2 energy flux did not result in increased bone mineral content or bone mineral density of the forearm in postmenopausal women [ 58 ]. Interestingly, in this systematic review, higher healing rates were associated with lower EFD.…”

Effect of external mechanical stimuli on human bone: a narrative review

“…Despite promoting fracture healing ESWT does not appear to have osteogenic effects on uninjured bone. A 2019 study found no significant differences in BMC and BMD in the healthy distal forearm of twelve non-osteoporotic post-menopausal women after six or twelve weeks of ESWT treatment [128]. The proposed mechanism of action focuses on the selective destruction of bony tissue to elicit an osteogenic response, so it is reasonable to speculate that ESWT yields the best results on fractures and nonunions rather than healthy bone.…”