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Treatment of Chronic Radial Epicondylitis with Botulinum Toxin A

A Double-Blind, Placebo-Controlled, Randomized Multicenter Study

¹ Centrum für Muskuloskeletale Chirurgie, Kliniken für Orthopädie,
Unfall- und Wiederherstellungschirurgie, Campus Virchow-Klinikum, Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin, Germany. E-mail address: richard.placzek{at}charite.de
² Orthopädische Universitätsklinik Frankfurt a.M. Marienburgstrasse 2, 60528 Frankfurt am Main, Germany
³ Orthopädische Universitätsklinik Hamburg-Eppendorf Martinistrasse 52, 20246 Hamburg, Germany
⁴ Orthopädische Universitätsklinik Heidelberg, Schlierbacher Landstrasse 200a, 69118 Heidelberg, Germany

Investigation performed at Orthopädische Universitätsklinik Hamburg-Eppendorf, Hamburg, Germany

Disclosure: In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from Ipsen Pharma, Ettlingen, Germany. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.

Methods: In the present prospective, controlled, double-blinded clinical trial, 130 patients were examined at sixteen study centers. A single injection of botulinum toxin A into the painful origin of the forearm extensor muscles was performed. Follow-up examinations were performed at two, six, twelve, and eighteen weeks. Clinical findings were documented with use of a new clinical pain score and with a visual analogue scale. A global assessment of the result of treatment was also provided by the patient and the attending doctor. Strength of extension of the third finger and the wrist was evaluated with use of the Brunner method, and grip strength (fist closure strength) was measured with a vigorimeter.

Results: The group treated with botulinum toxin A was found to have a significant improvement in the clinical findings, compared with those in the placebo group, as early as the second week after injection (p = 0.003). Subjective general assessment also showed improvement in that group, compared with the placebo group, at six weeks (p = 0.001) and at the time of the final examination (at eighteen weeks) (p = 0.001). There was a consistent increase in fist closure strength in both the group treated with botulinum toxin A and the control group, but there was no significant difference between groups. As was expected as a side effect, extension of the third finger was observed to be significantly weakened at two weeks but this complication had completely resolved at eighteen weeks.

Conclusions: We concluded that local injection of botulinum toxin A is a beneficial treatment for radial epicondylitis (tennis elbow). The treatment can be performed in an outpatient setting and does not impair the patient's ability to work.

Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.

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