Objective To determine the effectiveness of extracorporeal shock wave therapy compared with placebo in the treatment of chronic plantar fasciitis. Design Randomised, blinded, multicentre trial with parallel group design. Setting Nine hospitals and one outpatient clinic in Germany. Participants 272 patients with chronic plantar fasciitis recalcitrant to conservative therapy for at least six months: 135 patients were allocated extracorporeal shock wave therapy and 137 were allocated placebo. Main outcome measures Primary end point was the success rate 12 weeks after intervention based on the Roles and Maudsley score. Secondary end points encompassed subjective pain ratings and walking ability up to a year after the last intervention. Results The primary end point could be assessed in 94% (n=256) of patients. The success rate 12 weeks after intervention was 34% (n=43) in the extracorporeal shock wave therapy group and 30% (n=39) in the placebo group (95% confidence interval − 8.0% to 15.1%). No difference was found in the secondary end points. Few side effects were reported. Conclusions Extracorporeal shock wave therapy is ineffective in the treatment of chronic plantar fasciitis.
Facet joint pain is an important aspect of degenerative lumbar spine disease, and radiofrequency medial branch neurotomy remains an established therapy, while cryodenervation has still been poorly examined. This study was undertaken to examine the effects of medial branch cryodenervation in the treatment of lumbar facet joint pain. This was a prospective clinical case series. Patient selection was based on the history, physical examination and positive medial branch blocks. Percutaneous medial branch cryodenervation was performed using a Lloyd Neurostat 2000. Target parameters were low back pain (VAS), limitation of activity (McNab) and overall satisfaction. Fifty patients were recruited, and 46 completed the study. The follow-up time was 1 year. At 6 weeks, 33 patients (72%) were pain free or had major improvement of low back pain; 13 (28%) had no or little improvement. Including failures, mean low back pain decreased significantly from 7.7 preoperatively to 3.2 at 6 weeks, 3.3 at 3 months, 3.0 at 6 months and 4.2 at 12 months (P<0.0001). Limitation of the activities of daily living improved parallel to reduced pain. Our results suggest that medial branch cryodenervation is a safe and effective treatment for lumbar facet joint pain.
Background: Whereas various molecular working mechanisms of shock waves have been demonstrated, no study has assessed in detail the influence of varying energy flux densities (EFD) on new bone formation in vivo. Methods: Thirty Chinchilla bastard rabbits were randomly assigned to 5 groups (EFD 0.0, 0.35, 0.5, 0.9 and 1.2 mJ/mm2) and treated with extracorporeal shock waves at the distal femoral region (1,500 pulses; 1 Hz frequency). To investigate new bone formation, animals were injected with oxytetracycline at days 5–9 after shock wave application and sacrificed on day 10. Histological sections of all animals were examined using broad-band epifluorescent illumination, contact microradiography and Giemsa-Eosin staining. Results: Application of shock waves induced new bone formation beginning with 0.5 mJ/mm2 EFD and increasing with 0.9 mJ/mm2 and 1.2 mJ/mm2. The latter EFD resulted in new bone formation also on the dorsal cortical bone; cortical fractures and periosteal detachment also occurred. Conclusion: Here, for the first time, a threshold level is presented for new bone formation after applying shock waves to intact bone in vivo. The findings of this study are of considerable significance for preventing unwanted side effects in new approaches in the clinical application of shock waves.
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