OBJECTIVE: To compare extracorporeal shock wave therapy combined with oral medication and an exercise program versus sham treatment with medication and exercise for the treatment of chronic low back pain (CLBP). DESIGN: Randomized controlled trial. SETTING: Outpatient clinic at a university hospital. PARTICIPANTS: Eligibility criteria were age older than 18 years and duration of CLBP exceeding 3 months. Exclusion criteria were concurrent treatment or history of surgery for CLBP, cancer, fractures, infections, and disk degeneration. INTERVENTION: The intervention group received extracorporeal shock wave therapy once a week for 4 weeks along with oral medications and an exercise program. The control group received sham extracorporeal shock wave therapy along with oral medications and an exercise program. MAIN OUTCOME MEASURES: Visual analog scale and Oswestry Disability Index (ODI) were used to assess pain and disability at baseline and after 3 months. RESULTS: The pain score in the intervention group (N = 16) was 6.6 at baseline and 3.0 after 1 month (p < 0.0001) and 1.8 after 3 months (p < 0.0001). In the control group (N = 16), the pain score was 6.8 at baseline, 4.6 after 1 month (p < 0.0001), and 1.1 after 3 months (p < 0.0001). ODI scores decreased significantly in both groups compared with baseline values (first month: p < 0.001, third month: p < 0.05). The mean ODI score did not differ significantly between the groups (p = 0.942). CONCLUSION: Extracorporeal shock wave therapy combined with oral medication and exercise was safe and effective in the short-term treatment of chronic low back pain.

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