Extracorporeal Shock Wave Therapy for Lateral Epicondylitis

Objective To evaluate the effectiveness of extracorporeal shock wave therapy (ESWT) for the treatment of lateral epicondylitis. Design Randomized, double blind, placebo-controlled trial. The sample size conferred sufficient power to detect a difference of 20% in outcome scores, and blinding was checked. Setting Multicenter trial at orthopedic university hospitals, clinics, and practices in Germany and Austria, in the years 1998 to 2000. Participants Patients were recruited through press reports, health insurance companies, orthopedic practitioners, and hospitals. Eligibility criteria were a diagnosis of radiohumeral epicondylitis on ≥2 of 4 clinical tests, a Roles and Maudsley score of 3 or 4 (range, 1–4; no pain and full activity to pain limiting activity), and ≥6 months of conservative therapy that was terminated ≥2 weeks before entering the trial. Patients with arthritis, neurologic abnormalities, infection, or tumor in the upper extremity to be treated; bilateral symptoms, thrombopathy, or hyperthyroidosis; allergy to mepivacaine or taking anticoagulant therapy; or <18 years of age or pregnant were excluded. Patients (n = 272; mean age, 47 yrs; duration of symptoms, 25 mo; right arm affected, 76%; women, 53%) were assigned to ESWT or placebo (fake ESWT). Intervention Local anesthetic (3 mL of 1% mepivacaine) preceded 3 weekly treatments of low-energy ESWT (2000 pulses at an energy flux density of 0.07 to 0.09 mJ/mm2) administered by physicians experienced in the technique. The placebo group was assigned to the same regimen, but the shock waves were reflected by means of an air-filled foil. Main outcome measures Successful treatment was defined as a reduction of the Roles and Maudsley score to 1 or 2 at the 12-week follow-up if the patient had received no additional conservative therapy. Secondary endpoints at 6 and 12 weeks and 12 months were Roles and Maudsley scores, pain, and grip strength. Main results Data for the 12-week success/failure criterion were available for 90% of the patients. Success rates for the ESWT group and the placebo group were 25.8% and 25.4% (95% CI for the difference, −10.5% to 11.3%). Failure due to Roles and Maudsley scores remaining at 3 or 4 or due to additional treatments received during the period did not differ between groups, or when the data were stratified by center and device used. Roles and Maudsley scores of 1 or 2 did not differ for the groups at 6 or 12 weeks or after 12 months (ESWT, 65.7% vs. placebo, 65.3%; 76% follow-up). Neither pain nor pain-free grip strength differed for the groups at any point. More patients in the ESWT group than the placebo group guessed their group assignment correctly (71% vs. 47%). More minor side effects (principally reddening and swelling of the skin) occurred in the ESWT group. Conclusion Extracorporeal shock wave therapy was not effective in the treatment of lateral epicondylitis. After 1 year, two thirds of all patients showed improvement.

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