Context: Published data on extracorporeal shock wave therapy (ESWT) for chronic plantar fasciitis provide controversial evidence about the clinical relevance and effectiveness. Treatment parameters have significant influence on outcome and optimal treatment protocols have to be determined.

Objective: To assess the effect size and safety of ESWT compared to placebo in the treatment of chronic painful heel syndrome with a new electromagnetic device and an optimized protocol.

Design, Setting, and Participants: Prospective, double-blind, randomized, placebo-controlled trial conducted among 40 patients. Interventions: ESWT (0.25 mJ/mm²) or placebo without anesthesia. Both groups received 3 treatments of 2000 shock wave impulses, each session 1 week apart. Main Outcome Measures: The primary outcome was the percentage change of heel pain quantified by VAS composite score 12 weeks after the last intervention compared to baseline. Secondary endpoints were defined as changes of single VAS scores (morning pain, pain at daily activities and pain with force-meter application), success rates and changes in Roles and Maudsley score.

Results: ESWT resulted in a 73.2% reduction of heel pain regarding the primary endpoint VAS composite score compared to baseline, being 32.7% superior to placebo. Effect size reached clinical relevance (Mann-Whitney effect size (MW) = 0.6737; 0.6400 being the benchmark for medium-sized, relevant superiority, p = 0.0302 single-sided). With regard to the percentage changes of the single VAS scores and the Roles and Maudsley score, the effect size denoted relevant superiority of the ESWT as well (all MWs ≥ 0.6400). No relevant adverse events occurred.

Conclusion: The results of the present study advocate ESWT for refractory painful heel syndrome demonstrating clinically relevant effect sizes. Specific treatment protocols with proven effectiveness ought to be used in the clinical setting.

In orthopedic surgery, sterilization of bone used for reconstruction of osteoarticular defects caused by malignant tumors is carried out in different ways. At present, to devitalize tumor-bearing osteochondral segments, mainly extracorporal irradiation or autoclaving is used. Both methods have substantial disadvantages, e.g. loss of biomechanical and biological integrity of the bone. In particular integration at the autograft-host junction after reimplantation is often impaired due to alterations of the osteoinductivity following irradiation or autoclaving. As an alternative approach, high hydrostatic pressure (HHP) treatment of bone is a new technology, now being used in preclinical testing to inactivate tumor cells without alteration of biomechanical properties of bone, cartilage and tendons. The aim of this study was to investigate the influence of HHP on fibronectin (FN), vitronectin (VN), and type I collagen (col. I) as major extracellular matrix proteins of bone tissue, accountable among others for the osteoinductive properties of bone.

Fibronectin, vitronectin and type I collagen were subjected to HHP (300 and 600 MPa) prior to the coating of cell culture plates with these pre-treated proteins. Following the biological properties were measured by means of cell proliferation, adherence, and spreading of the human osteosarcoma cell line (Saos-2) and primary human osteoblast-like cells.

Up to 600 MPa all tested matrix proteins did not show any changes, regarding the biological properties adherence, spreading and proliferation.

We anticipate that, in orthopedic surgery, HHP can serve as a novel, promising methodical approach, by damaging normal and tumor cells without alteration of osteoinductive properties, thus facilitating osteointegration of the devitalized bone segment in cancer patients after reimplantation.